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Empowering Immunity, Defeating Cancer
Kineta
Jacques Bouchy
EVP Investor Rela ons &
Business Development
Shawn Iadonato
Chief Execu ve Officer
Thierry Guillaudeux
Chief Scien fic Officer
Empowering the
Immune System
Best Prac ces in Oncology Care
Healing with Precision
The Latest Advances in
Immuno-Oncology
February
Issue 01
2024
In the dynamic world of healthcare, 2024 places us at
the cutting edge of revolutionary advancements in
Immuno-Oncology. Our latest edition of "Healthcare
Everything" proudly presents the standout companies
reshaping the cancer treatment landscape.
This edition is dedicated to spotlighting the Best Companies
of 2024 in Immuno-Oncology, whose tireless dedication
and innovative methodologies are rewriting the narrative of
cancer care.
Like pioneers in uncharted territories, these companies are
pushing the boundaries of what was once considered
conceivable. From leveraging the immune system's
potential to crafting avant-garde therapies, they stand at the
forefront of a medical revolution.
Within the pages of this edition, anticipate captivating
stories of perseverance, resilience, and the indomitable
spirit of those who have devoted their lives to redefining the
benchmarks of cancer care. The Immuno-Oncology Frontier
isn't solely a scientific battleground; it vividly illustrates
human determination and the collective will to overcome
one of the most formidable adversaries we face.
"Trailblazing The Immuno-Oncology Frontier Best
Companies Of 2024" isn't just a compilation of success
stories; it's a celebration of the triumph of the human spirit
over adversity. It's an acknowledgment of the collaborative
efforts propelling us toward a future where cancer is not an
inescapable fate but a surmountable challenge.
Join us in recognizing and applauding these exceptional
companies that are shaping the narrative of Immuno-
Oncology in 2024. As we navigate this groundbreaking
frontier together, we are reminded that every discovery is a
victory in healthcare, and every step forward is a triumph
for humanity.
Wishing you an insightful reading and a renewed sense of
hope!
Managing Editor
Pioneering
Progress
-PeaShaw
Editor’s
Note
CoverStory
08
Empowering Immunity, Defeating Cancer
Kineta
Profile
CXO
Articles
22
30
18
26
Empowering the
Immune System
Best Prac ces in Oncology Care
Healing with Precision
The Latest Advances in
Immuno-Oncology
Sensius
Radiant Hope,
Revolu onary Healing
Lisa-Jean Clifford
Ar ficial Intelligence, Image Analysis
and Machine Learning in Pathology
– Is it Really Valuable?
Contents
Contact Us:
February, 2024
Managing Editor Executive Editor
Visualiser Art & Design Head Co-designer Art & Picture Editor
Business Development
Manager
Marketing Manager Business Development
Executives
Sales Executives
Technical Head Assistant Technical Head Technical Consultants
Digital Marketing
Manager
Assistant Digital
Marketing Manager
SME-SMO Executives
Research Analyst Circulation Manager
Editor-in-Chief
Abacus Bioscience
abacusbioscience.com
Alan Wahl
CEO
NodThera
nodthera.com
Alan Watt
CEO
Kineta
kineta.us
Shawn Iadonato, CEO
Thierry Guillaudeux, CSO
Jacques Bouchy,
EVP Investor Relations
& Business Development
Triumvira
Immunologics
triumvira.com
Paul Lammers
CEO
Sensius
sensiusthermo
therapy.com
Paul Van Den Biggelaar
CEO and Co-founder
Cover
Thierry Guillaudeux
Chief Scien fic Officer
My focus has
always been on new
drug development
involving the immune
system in cancer,
infec ous disease, and
inflamma on.
‘‘ ‘
‘
- Shawn Iadonato
Empowering Immunity, Defeating Cancer
Kineta
Jacques Bouchy
EVP Investor Rela ons &
Business Development
Shawn Iadonato
Chief Execu ve Officer
C
ancer presents a formidable challenge with its
complex strategies of immune evasion, and Kineta
is at the forefront of deciphering these complex
biological processes. In the ongoing struggle between
cancer and the immune system, a relentless battle unfolds
where tumors strive to escape detection, and the immune
system seeks to recognize and eradicate them.
Going beyond conventional therapies, Kineta delves into
the profound world of innate immunity, seeking to retrain
the body's ability to detect and kill cancer. Guided by the
seasoned expertise of Shawn Iadonato, Thierry
Guillaudeux, and Jacques Bouchy, the company is on a
mission to unravel the strategies of immune evasion
employed by tumors and develop innovative drugs to offer
patients new treatment options for managing cancer.
As a clinical-stage biotechnology firm, Kineta is dedicated
to transforming the lives of cancer patients through
groundbreaking immunotherapies. Focused on addressing
mechanisms of cancer immune resistance, the company
actively engages in the development of immunotherapies
poised to revolutionize and uplift the lives of patients facing
serious health challenges.
Shawn Iadonato, as Chief Executive Officer, brings over
twenty years of expertise in guiding startup biotech
companies and is also one of the co-founders of Kineta.
Thierry Guillaudeux, the Chief Scientific Officer, brings
over thirty years of experience in Immuno-Oncology,
steering Kineta's scientific initiatives from discovery to
clinical trials. Jacques Bouchy, the Executive Vice
President of Investor Relations and Business
Development, adds a wealth of commercial pharmaceutical
industry experience, ensuring Kineta's growth and impact.
Explore the strategies, leadership, and transformative
initiatives that position Kineta as a trailblazer in the
Immuno-oncology frontier, charting a course toward a
future where cancer can be met with resilience, innovation,
and hope.
Shawn's Odyssey in Drug Development
Shawn has played an important role in steering the course
of innovation as the Founder and former Chief Scientific
Officer of multiple companies in Seattle. He transitioned to
the role of CEO at Kineta in 2016, bringing his passion for
advancing healthcare solutions to a new level.
Reflecting on his journey, Shawn emphasizes his
commitment to advancing drug development in critical
areas such as cancer, infectious disease, and inflammation.
He states, "My focus has always been on new drug
development involving the immune system in cancer,
infectious disease, and inflammation."
Shawn sheds light on the transformative nature of his role,
stating, "The CEO role has really allowed me to narrow the
focus of the company to the immunotherapies that I thought
were most exciting. Most exciting scientifically, and most
exciting from a commercial perspective."
Under his leadership, Kineta underwent a strategic
refocusing, redirecting assets to align with the company's
emphasis on oncology. Shawn expresses his enthusiasm,
affirming, "My fundamental motivation is that I'm really
interested in groundbreaking science and new drug
development. I really like biotech and the process of
developing new drugs."
In describing the excitement fundamental in their work,
Shawn highlights the uniqueness of the areas they research,
emphasizing, "A lot of the areas that we work in are very
novel. So, it's not like people have done the same thing
before, and that novelty and innovation is very motivating."
Innovating for Patient Well-being in Immuno-Oncology
In explaining Kineta's mission, Thierry passionately
articulates, "The mission of Kineta is to develop new drugs
that are therapeutically very different than anything that's
been done before."
The mission of
Kineta is to develop
new drugs that are
therapeu cally very
different than
anything that's been
done before.
‘‘ ‘
‘
- Thierry Guillaudeux
Kineta directs its focus towards patients fighting with
advanced stages of cancer, those who have traversed
multiple lines of therapy and seek new treatments. Thierry
underscores the vision, stating, "Our mission is to develop
next-generation immunotherapies that transform patients'
lives."
Emphasizing the importance of strategic focus in fostering
innovation, Thierry echoes Shawn's sentiments, noting,
"Actually, I really think that if you want to be innovative,
you need to focus on a specific area." The strategic pivot to
immuno-oncology aligns with Thierry's lifelong dedication
to this field, driven by a recognition of cancer as a pervasive
challenge affecting both the young and the old worldwide.
Thierry notes, "To be on the top of innovation, you need to
focus the whole company in this specific field." Our focus
on immuno-oncology is a deliberate choice, recognizing the
complexity of science and the need for concentrated efforts
in a specialized area.
Kineta's is developing KVA12123, a new immunotherapy
that blocks an innate immune target called VISTA. VISTA
is a negative immune checkpoint that suppresses T cell
function, a key cancer fighting function, in a variety of
different types of tumors. Blocking VISTA can induce an
effective immune response to re-engage a suppressed
immune system to enable an anti-tumor response. This
monoclonal antibody is in clinical development as a twice
weekly infusion drug. KVA12123 is being evaluated in a
Phase 1/2 clinical trial as a monotherapy as well as in
combination with pembrolizumab in patients with advanced
solid tumors. The company is also developing another
monoclonal immunotherapy targeting CD27 that can
address exhausted T cells, another way to fight cancer.
Trailblazing the Immuno-Oncology Fron er: Best Companies of 2024
As an antibody-focused company, Kineta
distinguishes itself through the development of fully
human antibodies. Thierry emphasizes the
significance of this approach, stating, "Our antibodies
are innovative because they are fully human, and
that's also important for us because it prevents some
possible adverse events in patients." Safety remains
paramount in Kineta's attempts, with a deep-seated
concern for patients' well-being during drug
administration. Sharing Shawn's vision, Thierry adds,
"I think that was also one of the visions that Shawn
had in the company—to develop drugs that are safe
and improve efficacy for patients that need better drug
treatment options."
Navigating the Frontier
In the evolving landscape of cancer treatment, Thierry
articulates a pivotal shift from traditional approaches,
stating, "The field of cancer is evolving to new
immunotherapies that hold the promise of shrinking
tumors and turning cancer into a chronic disease that
can be managed" With a historical reliance on
chemotherapy, radiation and the subsequent
emergence of targeted therapy in the early 2000s, the
current industry focus lies in the space of immuno-
oncology."
Highlighting the progression of therapeutic
generations, Thierry explains, "And the current
generation is focused on immuno-oncology, and that's
where Kineta is leading." This latest wave
encompasses drugs that target PD1, PD-L1 and
CTLA-4, marking a significant breakthrough in 2010
and 2011. Their primary objective is to reinvigorate
the immune system, enabling it to naturally combat
cancer. However, Thierry acknowledges the
variability in efficacy across different types of cancer.
Kineta's focus is on the ongoing development of
immuno-oncology drugs. Thierry states, "Our focus is
to try to stimulate more immune cells and different
immune cells to really help the immune system to
fight back against cancer." While still in the clinical
development phase, this approach holds promise and
remains a key area of concentration for the company.
Delving into the complicated dynamics between
cancer cells and the immune system, Thierry explains,
"Our immune system has a really important role in
preventing cancer, and once a tumor becomes established,
it's usually because that tumor was able to defeat the
immune system in some way." Kineta's research is deeply
rooted in innate immunity and understanding how tumors
evade the immune response and devising strategies to
reverse this process, allowing the immune system to resume
its natural role in eliminating cancer cells.
A Spotlight on Innovation and Expertise
Shawn shares the company's bold approach, stating, "Our
company only works on things that are innovative and
novel. Novel drug targets and immunotherapies that haven't
been proven in the clinic yet. That's a high-risk, high-
reward proposition, and we've really positioned the
company in that space."
Expanding on this distinctive strategy, Thierry dives into
the technical complexities, stating, "We decided to focus on
a specific part of the immune response called innate
immunity. It may be a little bit technical, but most of the
companies right now are working on a specific type of cell
that we call the T cells." Thierry emphasizes the company's
differentiation by directing their focus toward a different
facet of the immune response—innate immunity, a critical
component in the early stages of the immune response.
Highlighting the uniqueness that sets Kineta apart, Jacques
underscores several key points. Firstly, he credits the
innovative science and the essential work of Thierry and
Shawn, particularly in the domain of innate immunity, as
the core area of research. Secondly, he points to the
exceptional experience of the management team, with
Thierry's extensive background in immuno-oncology and
immunology, complemented by seasoned professionals with
vast experience in major pharmaceutical companies.
Jacques further notes the strategic prowess of the team,
citing, "The management team has demonstrated
continued success, and they are the right team in place to
advance KVA12123 through clinical development and to
keep moving the company forward." With a background
from Schering-Plough and Glaxo Smith Kline, Jacques
brings his own wealth of commercial pharmaceutical
experience to the table.
Jacques further highlights, "Kineta is an entrepreneurial,
nimble company that's been able to advance our drug
programs very effectively in a capital efficient manner."
This, coupled with a strong leadership team and a
commitment to innovation, positions Kineta as a trailblazer
in the field.
Charting the Oncological Arms Race
In the battle against cancer, Thierry underscores the
perpetual challenge of tumors adapting and genetically
modifying themselves. The dynamic nature of tumors poses
Everything we do
is unique. Developing
immunotherapies that
are differen ated is
crucial for a rac ng
investors today and
ul mately clinicians
seeking novel
immunotherapies for
their pa ents.
‘‘ ‘
‘
- Jacques Bouchy
a substantial barrier in drug development, where initial
success often gives way to the tumor's ability to grow,
evade and evolve. This is a frightening challenge for
patients and clinicians, given tumors' remarkable mutation
rates compared to normal healthy tissue.
While the scientific community has achieved a
breakthrough with immune checkpoint inhibitors, Thierry
notes that only 20-30% of individuals treated benefit from
first-generation immunotherapies. Thus, the team at Kineta
remains committed in their belief that pursuing new innate
immune drug targets and developing novel
immunotherapies is imperative. The multi-pronged strategy
involves developing new drugs, combining them with
others, and persistently advancing to enhance cancer-
fighting efficacy.
Shawn emphasizes the importance of perseverance in this
pioneering endeavor, stating, "I really think that because
what we're doing is new, there's an element of
determination that's really important. We have to stick with
it and explore new solutions to address the medical needs of
cancer patients." Refusing to accept 'no' as an answer from
scientists, clinicians, investors, or regulators is a key driver,
allowing the team to forge ahead and seek innovative new
treatment alternatives for patients and healthcare providers.
Adding a business perspective, Jacques aligns with Shawn's
emphasis on perseverance, highlighting the uniqueness of
Kineta's endeavors. He points out that differentiation is
crucial in the marketplace for attracting investors today and
ultimately clinicians seeking distinctive immunotherapies
for their patients. Jacques states, "Everything we do is
unique.
Jacques further emphasizes the importance of
differentiation in instilling confidence in patients regarding
the effectiveness of new medicines. He notes, "Ultimately,
patients want to have confidence that a new medicine
they're going to take is going to help them achieve an
improved survival outcome for their cancer."
Insights from Pioneers
Shawn, a seasoned entrepreneur, imparts invaluable advice
for those embarking on the entrepreneurial journey,
emphasizing the need for perseverance and commitment.
He states, "I think that people have to understand that in
order to do something really great and amazing, it takes real
determination and commitment, and it doesn't happen
overnight." He underscores the reality that success in
developing a new drug requires overcoming numerous
obstacles, and true greatness is a product of sustained effort
over time.
Reflecting the spirit of endurance, Thierry emphasizes the
importance of optimism in the face of complexities. He
acknowledges the challenges posed by intricate scientific
endeavors, the need for patience in navigating difficulties,
and the unpredictable nature of the market. Thierry asserts,
"You have to be deeply positive and persistent to keep this
program moving forward and reach success." Intrinsic
positivity becomes a driving force in moving projects
forward despite the inevitable hurdles and challenges that
Kineta faces in the drug discovery and development
process.
Redefining Cancer Treatment through Unique Drug
Innovation
Kineta's unique identity is forged in its pursuit of
pioneering innate immunity-focused drugs that possess the
transformative capability to shrink tumors—a distinctive
objective that sets the company apart as a trendsetter in the
field of oncology. The core mission is to develop next-
generation immunotherapies that transform patients' lives.
Immunotherapies demonstrate efficacy to achieve tangible,
unprecedented health outcomes for patients and marking a
departure from conventional approaches.
Emphasizing the importance of focus and resilience, the
team at Kineta is persistent in their commitment to proving
the efficacy of KVA12123, their lead drug program as well
In a society heavily reliant on continuous medical advancements,
the impact of new drugs and vaccines on human lives is profound,
reshaping our ability to combat diseases effectively. Cancer, a
significant health challenge, remains a focal point for innovation.
The evolving landscape holds promise for unique and
transformative approaches, offering substantial improvements in
patient treatment and tangible effects on their lives.
Addressing the pressing needs of individuals in the advanced
stages of their cancer journey, Shawn expresses Kineta's
commitment to developing new treatment options. These
innovations aim to make an enormous difference for those who
are running out of treatment alternatives. The mission to develop
next-generation immunotherapies that transform patients' lives.
As a society, the dependence on revolutionary solutions is pivotal,
and Kineta envisions playing a pivotal role in this transformative
journey. The success of the company is tied to the positive impact
it can make on patients' lives. By consistently pushing the
boundaries of what is possible in medical innovation, Kineta
aspires to be a pillar of progress, providing hope and new
possibilities for individuals navigating the complexities of cancer
treatment.
Kineta's Vision for
Transformative Healthcare
as the second drug program targeting
CD27 that is also focused on improving
cancer treatment outcomes. The aim is
not only to showcase the success of
each of these drug programs
independently but also to demonstrate
the potential of these drugs when used
in combination with other cancer
therapies, radiation, and surgery.
Taking a tactical approach to these
aspirations, the company sets specific
milestones to mark its progress in drug
development. One such milestone
involves the release of clinical data for
KVA12123, the lead asset targeting
VISTA, slated for the second quarter of
2024. These key scientific updates,
shared at major cancer conferences,
serve as crucial checkpoints for
investors, clinicians and patients,
offering insights into the program's
advancement.
Looking ahead, Kineta outlines its
phased approach, with plans to
commence a phase two study in the
third quarter of 2024. As the journey
unfolds into 2025, the company
anticipates releasing additional clinical
data as both single agent therapy and in
combination with other drugs that will
further highlight the uniqueness and
differentiation of the assets under
development.
The landscape of oncology care has been evolving,
with a growing emphasis on empowering the
body's immune system to combat cancer. In recent
years, researchers and healthcare professionals have delved
into innovative approaches that go beyond conventional
treatments. This shift towards harnessing the power of the
immune system marks a significant advancement in
oncology care, providing new hope for patients struggling
with the complexities of cancer.
Discover the transformative power of immunotherapy in
cancer care – a journey towards personalized treatment and
enhanced well-being awaits you!
Understanding the Immune System's Role
The human immune system, a formidable defense
mechanism, is designed to identify and eliminate foreign
invaders, including cancer cells. In oncology care, the focus
is on bolstering this inherent ability to recognize and attack
malignant cells. Unlike traditional therapies such as
chemotherapy and radiation, which aim both healthy and
cancerous cells, immunotherapy seeks to enhance the
body's natural defenses, providing a more targeted and
personalized approach.
Immunotherapy Modalities
Several modalities fall under the umbrella of
immunotherapy, each designed to engage different facets of
the immune system. Checkpoint inhibitors, for instance,
Empowering the Immune System
18 | February 2024 www.healthcareeverything.com
Best
Practices in
Oncology
Care
19 | February 2024 www.healthcareeverything.com
-Pearl Shaw
block proteins that hinder immune cells from accepting and
attacking cancer cells. Adoptive cell therapy involves
extracting, modifying, and reintroducing a patient's immune
cells to enhance their cancer-fighting capabilities.
Monoclonal antibodies, another type of immunotherapy, are
designed to bind to specific proteins on cancer cells,
marking them for the destruction of the immune system.
Combining Traditional and Immunotherapy
The integration of immunotherapy with traditional
treatments is becoming a hallmark of comprehensive
oncology care. This approach acknowledges the strengths
of both modalities, leveraging the immediate impact of
conventional treatments like surgery or chemotherapy while
empowering the immune system for long-term defense. The
synergy between these approaches represents a dynamic
shift towards a more holistic and patient-centered model of
cancer care.
Personalized Medicine and Biomarkers
Advancements in genomic research have paved the way for
personalized medicine in oncology. By analyzing the
exclusive genetic makeup of a patient's tumor, healthcare
professionals can tailor treatment strategies to target
specific mutations driving cancer growth. Biomarkers play
a crucial role in identifying individuals who are most likely
to benefit from immunotherapy, enabling a more precise
and effective intervention. This personalized approach not
only enhances treatment efficacy but also minimizes
unnecessary side effects, promoting a higher quality of life
for patients.
Addressing Challenges and Side Effects
While immunotherapy offers promising outcomes, it is not
without challenges. Adverse reactions, known as immune-
related adverse events (irAEs), can occur as the immune
system becomes hyperactive. Managing these side effects
requires a nuanced understanding of the patient's overall
health and a proactive approach to mitigate potential
complications. Striking a balance between activating the
immune system and preventing collateral damage remains a
key consideration in optimizing immunotherapy
interventions.
Patient Education and Empowerment
In the realm of oncology care, patient education plays a
pivotal role. Empowering individuals with knowledge of
their treatment options, potential side effects, and the
rationale behind therapeutic decisions fosters a
collaborative relationship between patients and healthcare
providers. This shared decision-making process not only
enhances treatment adherence but also contributes to a more
positive and informed patient experience.
Research Frontiers and Future Prospects
Ongoing research in immunotherapy is uncovering new
frontiers and expanding the arsenal of available treatments.
Combination therapies, utilizing multiple
immunotherapeutic agents or combining immunotherapy
with other modalities, are currently under investigation.
Moreover, the exploration of novel targets and the
development of next-generation immunotherapies hold
promise for further refining and expanding the scope of
immune-based interventions.
Conclusion
The paradigm shift towards immunotherapy in oncology
care marks a profound advancement in the fight against
cancer. By harnessing the body's natural defenses,
healthcare professionals are navigating uncharted territory,
offering patients a more targeted and personalized approach
to treatment. The integration of immunotherapy with
traditional modalities, coupled with personalized medicine
and ongoing research endeavors, paints a promising picture
for the future of oncology care. As we continue to unravel
the complexities of the immune system and its interactions
with cancer, the journey towards empowering the body's
defenses is a testament to the resilience of both science and
the human spirit in the face of this formidable adversary.
20 | February 2024 www.healthcareeverything.com
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C
ancer, a malignant disease that affects millions of
lives, necessitates a thoughtful approach beyond
conventional methods of treatment. It's not just
about eliminating tumor cells; it's about preserving life's
quality throughout the process. In this relentless pursuit of
comprehensive cancer care, Sensius emerges as a source of
hope and innovation.
Going beyond the conventional trio of radiotherapy,
chemotherapy, and immunotherapy, Sensius integrates
controlled heating of deep-seated tumors into their
treatment methodology. The result is not only the effective
eradication of malignant cells but also a meticulous
preservation of surrounding tissues and organs.
The driving force behind this transformative endeavor is
Paul van den Biggelaar, Co-Founder and CEO of
Sensius. With rich experience spanning entrepreneurship,
Sensius
Radiant Hope, Revolutionary Healing
healthcare, politics, and technology, Paul brings a well-
rounded skill set and profound industry insight to the table.
His leadership is instrumental in guiding Sensius towards
its mission of enhancing the perspective for cancer patients
through the innovative application of thermotherapy.
In an exclusive interview with Paul, we delved into the
intricate details of Sensius' approach and discovered how
they are leading a transformative change in the immuno-
oncology frontier.
Please share about your professional background and
career highlights that led you to your current position.
As a former member of the Executive Team of Nucletron
(now an Elekta company), world leader in brachytherapy, I
was intrigued by hyperthermia, as it improves the effect of
existing therapies without additional toxicity. I have studied
its commercial feasibility since 2007. The work of Prof.
Van Rhoon and Prof. Paulides at Erasmus University
Medical Center (Rotterdam, the Netherlands) demonstrated
a paradigm shift in technology and workflow. They had
support letters from other universities. It was obvious to my
partner and serial entrepreneur Peter van Paassen and
myself that we needed to team up with Van Rhoon and
Paulides to build Sensius into a company that will change
the way we treat cancer.
Can you provide an overview of your company and its
focus on immuno-oncology?
Sensius is a medical device company that provides
microwave-based clinical thermotherapy solutions intended
as adjuvant treatment of specific solid cancers. The Sensius
system is a combination of proprietary and patented
hardware, software and expert services. Sensius aspires to
become the leading brand in the segment of Thermotherapy
by providing the adjuvant clinical tools for the treatment of
certain types of cancer.
Paul Van Den Biggelaar
CEO and Co-Founder
Sensius
22 | February 2024 www.healthcareeverything.com
Our thermotherapy is used in combination with radio-
chemo- and immunotherapy. Thermotherapy is the next
quality level in hyperthermia and provides focus and
o
controlled mild heating of the tumor to max 45 C. Sensius'
unique and patented technology enables us to focus the heat
to the tumor and protect nearby tissues from the heat. At
least five different biological methods of action are
triggered by this effect. The mild heating is an
immunomodulator and sensitizer for radio- and
chemotherapy. Research of prof. Weigelin (University of
Tübingen, Germany) demonstrates that mild heating of the
tumor increases T-cell killing efficiency with as much as
500%.
How does your company's approach to immuno-
oncology differ from other players in the field?
We use 20 microwave antennas, guided by AI software and
sensory data, to focus the heat to the tumor. Thermotherapy
by Sensius is non-invasive and is significantly more cost
effective than existing therapies. Adoption in clinics is
facilitated through alignment with established radiotherapy
workflow. The approach can be applied on a range of
different solid tumors. Thermotherapy can be applied safely
and cost-effectively without additional toxicity for patients.
What are some of the challenges your company faces in
the immuno-oncology field, and how are you addressing
them?
Many phase III studies have demonstrated the positive
effects of mild heating on tumor response without
additional toxicity, but current commercial solutions are not
widely adopted because of substantial technical limitations
which prevent robust and reproducible routine clinical use.
Sensius offers improved clinical efficacy and ease-of-use
and economic benefits of its thermotherapy: it is our
challenge to make oncologists comfortable with this
additional treatment option to the benefit of the patient
(survivorship, quality of life). Healthcare payers (insurance
companies, governments) will need to recognize how our
economic benefits (reduced recurrence, lower cost of
treatment of toxic effects, faster reintegration in society)
will reduce the economic burden of cancer.
What are some of the key products or therapies in your
current portfolio that demonstrate your commitment to
immuno-oncology?
Our launching product is the FocusCollar for treatment of
solid tumors in the head and neck area. This product is
based on the extensive experience of Eramus University
Medical Center and incorporates the experience of at least 5
more clinical research centers from all over the world. We
are also part of a consortium of 4 Dutch universities to
develop the FocusCup, a solution to treat breast cancer.
More tumor types are on our roadmap for the future.
Sensius will collaborate with clinical research centers,
universities and other companies on research and clinical
studies to improve quality of life and survivorship for
cancer patient.
Thermotherapy by
Sensius is non-invasive and is
significantly more cost effec ve
than exis ng therapies.
Trailblazing the Immuno-Oncology Fron er: Best Companies of 2024
23 | February 2024 www.healthcareeverything.com
Can you share any innovative technologies or techniques
that your company is currently exploring or
implementing in its research and development efforts?
Sensius uses a combination of technologies to achieve
performance, ease-of-use and economic benefits.
Performance to focus and control energy deposition on only
the tumor is implemented through 20 microwave antennas
emitting energy at a carefully selected frequency and
positioned strategically around the tumor area. AI-based
software calculates the exact setting for each antenna
individually to protect tissues around the tumor. This
secures a personalized treatment plan, which can be adapted
during treatment to accommodate for the specific situation
of the patient. A patented waterbolus (a flexible water
container between the device and the patient) secures the
transfer of the energy from the antennas into the body and
makes the patient comfortable. Workflow and patient
positioning are similar to radiotherapy, while a modular
system architecture support the treatment of different tumor
sites in the body.
What are the key milestones and achievements in your
company's history, particularly in the field of immuno-
oncology?
On our clinical prototypes, Erasmus University Medical
Center has already treated over 70 patients for head and
neck cancer. The results are published (Paulides et al 2016,
Verduijn et al 2018, Kroesen et al 2021) and show
significant benefits. Erasmus MC will start a new clinical
trial in the first half of 2024 with support of Sensius. The
commercial solution for head and neck cancer, the
FocusCollar will be ready for commercial deployment at
the end of 2025. Already over 15 clinics in Western-Europe,
the UK and in the USA want to participate in multi-center
international confirmation studies using the FocusCollar.
How do you see the immuno-oncology market evolving
in the next few years, and how is your company
positioned to capitalize on these changes?
Thermotherapy will improve the life of people with cancer
as it offers the possibility to improve survivorship and
quality of life. It can be used on multiple tumor sites in
combination with radiotherapy, chemotherapy and
immunotherapy. It is easy to adopt in oncology clinics and
will reduce the economic burden of cancer for society.
th
Therefore, we believe thermotherapy will become the 4
pillar in cancer treatment.
24 | February 2024 www.healthcareeverything.com
Healing with Precision
In the dynamic world of cancer care, immuno-oncology
has emerged as a transformative force, leveraging the
body's own defenses to combat the complexities of this
formidable adversary. Recent breakthroughs in this field
have ushered in an era of precision medicine, offering
targeted treatments tailored to each patient's unique
biological makeup.
Discover the future of cancer care – from personalized
treatments to overcoming challenges. Embrace immuno-
oncology's transformative journey for hope and healing!
The Foundation of Immuno-Oncology
At its core, immuno-oncology utilizes the innate ability of
the immune system to identify and eliminate cancer cells.
Unlike traditional approaches, such as chemotherapy and
radiation, which directly attack tumors, immuno-oncology
focuses on enhancing the body's natural ability to recognize
and eradicate malignant cells. This not only promises
increased efficacy but also suggests a potential reduction in
side effects compared to conventional therapies.
Checkpoint Inhibitors: Releasing the Immune Response
A pivotal advancement in immuno-oncology is the
development of checkpoint inhibitors. These drugs block
specific proteins that contribute to the immune system,
enabling it to recognize and attack cancer cells more
effectively. Pembrolizumab and nivolumab, prominent
members of this drug class, have demonstrated remarkable
success in various cancers, including melanoma and lung
cancer.
CAR-T Cell Therapy: A Personalized Approach
Another groundbreaking avenue is CAR-T cell therapy, a
personalized treatment involving the modification of a
patient's immune cells to target cancer cells specifically.
Beginning with the extraction of T cells from the patient's
blood, genetic engineering introduces chimeric antigen
receptors (CARs) that recognize cancer cells. These
modified cells are then transferred into the patient. CAR-T
therapy has shown promise in treating certain blood
cancers, showcasing the potential of personalized
immunotherapies.
Monoclonal Antibodies: Precision Strikes Against
Cancer
Monoclonal antibodies, designed to target specific proteins
on cancer cell surfaces, represent another pivotal
development. By attaching to these proteins, these
antibodies flag cancer cells for immune system destruction.
Trastuzumab and rituximab have demonstrated success in
treating breast cancer and lymphomas, highlighting the
precision and efficacy of this targeted approach.
Combination Therapies: Maximizing Impact
Researchers are discovering the potential of combining
different immuno-oncology agents to maximize impact.
Combinations of checkpoint inhibitors with other
immunotherapies or conventional treatments such as
chemotherapy create a synergistic effect, enhancing the
body's ability to recognize and eliminate cancer cells. These
approaches not only improve response rates but also
contribute to a more comprehensive treatment strategy.
Biomarkers: Guiding Treatment Decisions
In the time of precision medicine, biomarkers are essential
in guiding treatment decisions. Biomarker testing allows
healthcare professionals to identify specific characteristics
or genetic mutations in a patient's tumor, helping determine
the most effective immuno-oncology approach. This
26 | February 2024 www.healthcareeverything.com
TheLatest Advances in
Immuno-Oncology
27 | February 2024 www.healthcareeverything.com
-Pearl Shaw
personalized approach minimizes trial-and-error, ensuring
patients receive interventions most likely to be beneficial
for their unique cancer profile.
Tumor Microenvironment: A Critical Player
Understanding the tumor microenvironment is becoming
increasingly crucial in immuno-oncology. The interactions
between cancer cells and their surroundings can influence
the effectiveness of immunotherapies. Ongoing research
explores ways to modulate the tumor microenvironment,
making it more receptive to immune system attacks and
enhancing the overall success of immuno-oncology
interventions.
Patient Advocacy and Support
Amidst the scientific strides, the importance of patient
advocacy and support cannot be overstated. Empowering
patients with information, providing emotional support, and
fostering a collaborative healthcare environment contribute
significantly to the overall success of immuno-oncology
treatments. Active participation in patient advocacy groups
and support networks helps amplify patients' voices,
ensuring that their unique needs and challenges are
addressed in the evolving landscape of cancer care.
Precision Oncology and Artificial Intelligence
Advancements in artificial intelligence (AI) are increasingly
playing a role in immuno-oncology. AI algorithms analyze
vast datasets, including genomic information, patient
records, and treatment outcomes, to identify patterns and
predict the most effective treatment strategies. This
intersection of technology and medicine is paving the way
for more precise and personalized cancer care, offering
tailored interventions based on comprehensive data
analysis.
Immunotherapy in Early-Stage Cancers
While immuno-oncology has shown significant success in
treating advanced-stage cancers, there is a growing interest
in its application in early-stage cancers. Research is
underway to explore the efficacy of immunotherapy as an
adjuvant or neoadjuvant treatment, aiming to eliminate
residual cancer cells after surgery or to shrink tumors before
surgical removal. This expansion of immuno-oncology into
earlier stages of cancer holds the potential to further
improve outcomes and reduce the risk of recurrence.
Cost and Accessibility
Despite the promise of immuno-oncology, concerns about
cost and accessibility persist. These advanced therapies can
be expensive, posing challenges for widespread adoption
and equitable access. Researchers and policymakers are
keenly addressing these issues, working towards developing
more cost-effective approaches and ensuring that these
cutting-edge treatments are accessible to a broader
population.
Challenges and Future Directions
While immuno-oncology holds immense promise,
challenges exist. Managing side effects, known as immune-
related adverse events, requires a nuanced approach to
ensure patient safety. Researchers are actively exploring
ways to expand the applicability of immuno-oncology to a
broader spectrum of cancers and investigating novel targets
for intervention.
Conclusion
As we navigate this dynamic frontier of immuno-oncology,
the expanding horizons bring both promise and challenges.
Understanding the intricacies of the tumor
microenvironment, prioritizing patient advocacy,
integrating artificial intelligence for precision, exploring
immunotherapy in early-stage cancers, addressing concerns
about cost and accessibility, and continuing research
endeavors are pivotal steps in advancing the field.
The strides made in immuno-oncology are not only
scientific breakthroughs but also a testament to the
collaborative efforts of researchers, healthcare
professionals, and advocates. Embracing these innovations
and addressing challenges collectively will pave the way for
a future where immuno-oncology becomes an integral part
of standard cancer care, offering hope and healing with
unprecedented precision.
28 | February 2024 www.healthcareeverything.com
here has been a vast uptick in technological
Tadvancements in the laboratory industry for digital
pathology and Artificial Intelligence solutions. In
fact, AI is the buzzword of the day. What is the difference
between algorithms, uses and accuracy?
It's very easy to conflate the terminology and in some cases,
the differences are very clear while in others the lines are a
bit less distinguishable. In short, Artificial Intelligence (AI)
and Machine Learning (ML) are closely related, but you
can think of it more as a hierarchical relationship. They
both relate to computers and programming; however, AI
algorithms rely on human input and ML algorithms are
taught. In other words, AI requires humans to provide
inputs such as visual perception, interpretation, decision
making, and results in algorithms that can make decisions
based on data that they have been trained on.
Whereas ML algorithms are based on building models, or
neural networks, that are trained to identify patterns and
trends in information to make decisions. ML is used to
classify data and recognize patterns; this is actually
essential to many AI algorithms.
Image Analysis (IA) is more about extracting data for a
purpose, or multiple purposes from an image. This is very
useful in workflow application optimization and can
provide significant added value to AI and ML, but more to
digital pathology solutions and their adoption.
There are two factions of thought on the overall use of these
technologies in patient diagnosis and care. The first is pro-
innovative technology and this group sees the benefits of
being able to use well-developed, trained and tested
algorithms in a variety of workflows. Some of the
professionals who fall in this community are for all uses,
some are for a subset and some are for a limited set of uses.
The second is anti-adoption.
Overall, these use cases fall into the following general
categories:
Diagnosis
AI and ML algorithms are typically deployed for use in
diagnosis. They can be used for preprocessing images to
provide a pathologist with an interpretation of the
specimen. This can include the image which typically
overlays on the original and shows a 'hot spot' view of the
cancer within that slide and can also provide textual and
contextual data i.e.: percentage of proliferation, grade of
cancer, number of positive and negative cells, etc. This type
of algorithm can often be used as a region of interest (ROI)
that is manually invoked by the pathologist on a slide or
area of a slide that they are looking for more insight on.
When integrated within a digital pathology solution, this
can also provide a streamlined workflow to include
capturing the image and output to include in a final report in
support of the pathologist's diagnosis. These algorithms can
be used (if FDA cleared for diagnosis or validated as an
LDT by the laboratory/pathologist) as diagnostic or as an
aid to the pathologist in rendering their diagnosis.
Workflow Optimization
IA algorithms provide a streamlined workflow through the
preprocessing analysis of images. These algorithms can
perform such tasks as auto registration of images, ensuring
that the images in a virtual slide tray are in the correct
order, analyzing images to make a priority assessment and
move cases with a higher probability of being positive, or
more complex, higher in the pathologist's worklist.
30 | February 2024 www.healthcareeverything.com
For more than 2 decades, Lisa-Jean Clifford has been a
noteworthy leader in the high-tech healthcare solu ons
space. Lisa-Jean's passion for making a posi ve impact on
the lives of pa ents through technology can be traced back
to her tenure at McKesson and IDX, now GE Healthcare,
where she served in vital business development and
marke ng roles and to Psyche Systems, an LIS solu on
provider, where she was the CEO for eleven years.
Now, recognized as an industry expert, she ac vely
par cipates in numerous boards including the Associa on
of Pathology Informa cs and MLO's Editorial Advisory
Board. She is widely published in many top laboratory
publica ons and noteworthy news sources, such as Forbes,
CAP Today, Medical Laboratory Observer, and Health Data
Management. Also, she is a highly sought-a er speaker and
focuses on delivering valuable content in cri cal areas such
as lab automa on including so ware and interoperability,
digital pathology, AI in pathology, lab informa cs, oncology,
and women's health.
Lisa-Jean's success can be a ributed to her perseverance,
integrity, her high-regard for ethics, and her desire to
con nue to learn, grow, and move technology solu ons in
a forward direc on for healthcare. Her collabora on with
industry partners, customers, colleagues, and compe tors
combined with her commitment to excep onal customer
rela onships is what dis nguishes her drive to foster a win-
win for the healthcare industry as a whole.
Algorithms also contribute to significant efficiency and
accuracy gains in use by pathologists. They can perform
calculations and computational work that software can do
exponentially faster than a human. This also removes the
need for tedious, manual tasks to be performed by high-
quality resources, such as pathologists, and affords them the
ability to focus on their expertise, the interpretation and
diagnosis of the patient.
Quality Assurance or Control
Algorithms can also be configured, or deployed, to provide
either an automatic review of all cases or be set to do a
review of a predetermined number or percentage of cases to
support regulatory requirements for review or for internal
training and safety. In this use case, the algorithms would
be run either before a case is signed out, but after it is
diagnosed, or after it is signed out to flag any questionable
diagnosis. It can highlight areas that may have been
missed, flag a tumor that may have been identified as a
grade 2 when it was determined to be a 4 by the algorithm,
etc.
The second set of professionals in this community are not
bought into the safety or use of algorithms in diagnostic
practice. There is the argument that many of these are not
fully tested, they are not able to be used "out of the box" for
a variety of reasons leading to a wide variation in how
images are viewed (color saturation, stain types, scanner file
formats, etc.). Many of the algorithms are rated on their
accuracy by a correlation factor and pathologists are not
always in concordance with themselves 100% of the time,
never mind with each other.
Then, there is the concern that drift results can occur.
Recently, Fortune reported that a study conducted by
Stanford University found that "Over just a few months,
ChatGPT went from correctly answering a simple math
problem 98% of the time to just 2%". While this is not
indicative of what a commercially available, tested
pathology algorithm would encounter, it does add to the
doubt of those who are in this community of adaptors.
In summary, algorithms, when tested and validated by each
laboratory for deployment within a digital workflow
solution can provide improved efficiency, streamlined
workflow, reduce errors and increase the experience for the
pathologist.
31 | February 2024 www.healthcareeverything.com
Transforming Healthcare
are
Health
Everything
www.healthcareeverything.com

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Trailblazing The Immuno-Oncology Frontier Best Companies Of 2024.pdf

  • 1. Empowering Immunity, Defeating Cancer Kineta Jacques Bouchy EVP Investor Rela ons & Business Development Shawn Iadonato Chief Execu ve Officer Thierry Guillaudeux Chief Scien fic Officer Empowering the Immune System Best Prac ces in Oncology Care Healing with Precision The Latest Advances in Immuno-Oncology February Issue 01 2024
  • 2.
  • 3.
  • 4. In the dynamic world of healthcare, 2024 places us at the cutting edge of revolutionary advancements in Immuno-Oncology. Our latest edition of "Healthcare Everything" proudly presents the standout companies reshaping the cancer treatment landscape. This edition is dedicated to spotlighting the Best Companies of 2024 in Immuno-Oncology, whose tireless dedication and innovative methodologies are rewriting the narrative of cancer care. Like pioneers in uncharted territories, these companies are pushing the boundaries of what was once considered conceivable. From leveraging the immune system's potential to crafting avant-garde therapies, they stand at the forefront of a medical revolution. Within the pages of this edition, anticipate captivating stories of perseverance, resilience, and the indomitable spirit of those who have devoted their lives to redefining the benchmarks of cancer care. The Immuno-Oncology Frontier isn't solely a scientific battleground; it vividly illustrates human determination and the collective will to overcome one of the most formidable adversaries we face. "Trailblazing The Immuno-Oncology Frontier Best Companies Of 2024" isn't just a compilation of success stories; it's a celebration of the triumph of the human spirit over adversity. It's an acknowledgment of the collaborative efforts propelling us toward a future where cancer is not an inescapable fate but a surmountable challenge. Join us in recognizing and applauding these exceptional companies that are shaping the narrative of Immuno- Oncology in 2024. As we navigate this groundbreaking frontier together, we are reminded that every discovery is a victory in healthcare, and every step forward is a triumph for humanity. Wishing you an insightful reading and a renewed sense of hope! Managing Editor Pioneering Progress -PeaShaw
  • 7. Profile CXO Articles 22 30 18 26 Empowering the Immune System Best Prac ces in Oncology Care Healing with Precision The Latest Advances in Immuno-Oncology Sensius Radiant Hope, Revolu onary Healing Lisa-Jean Clifford Ar ficial Intelligence, Image Analysis and Machine Learning in Pathology – Is it Really Valuable? Contents
  • 8. Contact Us: February, 2024 Managing Editor Executive Editor Visualiser Art & Design Head Co-designer Art & Picture Editor Business Development Manager Marketing Manager Business Development Executives Sales Executives Technical Head Assistant Technical Head Technical Consultants Digital Marketing Manager Assistant Digital Marketing Manager SME-SMO Executives Research Analyst Circulation Manager Editor-in-Chief
  • 9. Abacus Bioscience abacusbioscience.com Alan Wahl CEO NodThera nodthera.com Alan Watt CEO Kineta kineta.us Shawn Iadonato, CEO Thierry Guillaudeux, CSO Jacques Bouchy, EVP Investor Relations & Business Development Triumvira Immunologics triumvira.com Paul Lammers CEO Sensius sensiusthermo therapy.com Paul Van Den Biggelaar CEO and Co-founder
  • 10. Cover Thierry Guillaudeux Chief Scien fic Officer My focus has always been on new drug development involving the immune system in cancer, infec ous disease, and inflamma on. ‘‘ ‘ ‘ - Shawn Iadonato
  • 11. Empowering Immunity, Defeating Cancer Kineta Jacques Bouchy EVP Investor Rela ons & Business Development Shawn Iadonato Chief Execu ve Officer
  • 12. C ancer presents a formidable challenge with its complex strategies of immune evasion, and Kineta is at the forefront of deciphering these complex biological processes. In the ongoing struggle between cancer and the immune system, a relentless battle unfolds where tumors strive to escape detection, and the immune system seeks to recognize and eradicate them. Going beyond conventional therapies, Kineta delves into the profound world of innate immunity, seeking to retrain the body's ability to detect and kill cancer. Guided by the seasoned expertise of Shawn Iadonato, Thierry Guillaudeux, and Jacques Bouchy, the company is on a mission to unravel the strategies of immune evasion employed by tumors and develop innovative drugs to offer patients new treatment options for managing cancer. As a clinical-stage biotechnology firm, Kineta is dedicated to transforming the lives of cancer patients through groundbreaking immunotherapies. Focused on addressing mechanisms of cancer immune resistance, the company actively engages in the development of immunotherapies poised to revolutionize and uplift the lives of patients facing serious health challenges. Shawn Iadonato, as Chief Executive Officer, brings over twenty years of expertise in guiding startup biotech companies and is also one of the co-founders of Kineta. Thierry Guillaudeux, the Chief Scientific Officer, brings over thirty years of experience in Immuno-Oncology, steering Kineta's scientific initiatives from discovery to clinical trials. Jacques Bouchy, the Executive Vice President of Investor Relations and Business Development, adds a wealth of commercial pharmaceutical industry experience, ensuring Kineta's growth and impact. Explore the strategies, leadership, and transformative initiatives that position Kineta as a trailblazer in the Immuno-oncology frontier, charting a course toward a future where cancer can be met with resilience, innovation, and hope. Shawn's Odyssey in Drug Development Shawn has played an important role in steering the course of innovation as the Founder and former Chief Scientific Officer of multiple companies in Seattle. He transitioned to the role of CEO at Kineta in 2016, bringing his passion for advancing healthcare solutions to a new level. Reflecting on his journey, Shawn emphasizes his commitment to advancing drug development in critical areas such as cancer, infectious disease, and inflammation. He states, "My focus has always been on new drug development involving the immune system in cancer, infectious disease, and inflammation." Shawn sheds light on the transformative nature of his role, stating, "The CEO role has really allowed me to narrow the focus of the company to the immunotherapies that I thought were most exciting. Most exciting scientifically, and most exciting from a commercial perspective." Under his leadership, Kineta underwent a strategic refocusing, redirecting assets to align with the company's emphasis on oncology. Shawn expresses his enthusiasm, affirming, "My fundamental motivation is that I'm really interested in groundbreaking science and new drug development. I really like biotech and the process of developing new drugs." In describing the excitement fundamental in their work, Shawn highlights the uniqueness of the areas they research, emphasizing, "A lot of the areas that we work in are very novel. So, it's not like people have done the same thing before, and that novelty and innovation is very motivating." Innovating for Patient Well-being in Immuno-Oncology In explaining Kineta's mission, Thierry passionately articulates, "The mission of Kineta is to develop new drugs that are therapeutically very different than anything that's been done before." The mission of Kineta is to develop new drugs that are therapeu cally very different than anything that's been done before. ‘‘ ‘ ‘ - Thierry Guillaudeux
  • 13. Kineta directs its focus towards patients fighting with advanced stages of cancer, those who have traversed multiple lines of therapy and seek new treatments. Thierry underscores the vision, stating, "Our mission is to develop next-generation immunotherapies that transform patients' lives." Emphasizing the importance of strategic focus in fostering innovation, Thierry echoes Shawn's sentiments, noting, "Actually, I really think that if you want to be innovative, you need to focus on a specific area." The strategic pivot to immuno-oncology aligns with Thierry's lifelong dedication to this field, driven by a recognition of cancer as a pervasive challenge affecting both the young and the old worldwide. Thierry notes, "To be on the top of innovation, you need to focus the whole company in this specific field." Our focus on immuno-oncology is a deliberate choice, recognizing the complexity of science and the need for concentrated efforts in a specialized area. Kineta's is developing KVA12123, a new immunotherapy that blocks an innate immune target called VISTA. VISTA is a negative immune checkpoint that suppresses T cell function, a key cancer fighting function, in a variety of different types of tumors. Blocking VISTA can induce an effective immune response to re-engage a suppressed immune system to enable an anti-tumor response. This monoclonal antibody is in clinical development as a twice weekly infusion drug. KVA12123 is being evaluated in a Phase 1/2 clinical trial as a monotherapy as well as in combination with pembrolizumab in patients with advanced solid tumors. The company is also developing another monoclonal immunotherapy targeting CD27 that can address exhausted T cells, another way to fight cancer. Trailblazing the Immuno-Oncology Fron er: Best Companies of 2024
  • 14.
  • 15. As an antibody-focused company, Kineta distinguishes itself through the development of fully human antibodies. Thierry emphasizes the significance of this approach, stating, "Our antibodies are innovative because they are fully human, and that's also important for us because it prevents some possible adverse events in patients." Safety remains paramount in Kineta's attempts, with a deep-seated concern for patients' well-being during drug administration. Sharing Shawn's vision, Thierry adds, "I think that was also one of the visions that Shawn had in the company—to develop drugs that are safe and improve efficacy for patients that need better drug treatment options." Navigating the Frontier In the evolving landscape of cancer treatment, Thierry articulates a pivotal shift from traditional approaches, stating, "The field of cancer is evolving to new immunotherapies that hold the promise of shrinking tumors and turning cancer into a chronic disease that can be managed" With a historical reliance on chemotherapy, radiation and the subsequent emergence of targeted therapy in the early 2000s, the current industry focus lies in the space of immuno- oncology." Highlighting the progression of therapeutic generations, Thierry explains, "And the current generation is focused on immuno-oncology, and that's where Kineta is leading." This latest wave encompasses drugs that target PD1, PD-L1 and CTLA-4, marking a significant breakthrough in 2010 and 2011. Their primary objective is to reinvigorate the immune system, enabling it to naturally combat cancer. However, Thierry acknowledges the variability in efficacy across different types of cancer. Kineta's focus is on the ongoing development of immuno-oncology drugs. Thierry states, "Our focus is to try to stimulate more immune cells and different immune cells to really help the immune system to fight back against cancer." While still in the clinical development phase, this approach holds promise and remains a key area of concentration for the company. Delving into the complicated dynamics between cancer cells and the immune system, Thierry explains, "Our immune system has a really important role in
  • 16. preventing cancer, and once a tumor becomes established, it's usually because that tumor was able to defeat the immune system in some way." Kineta's research is deeply rooted in innate immunity and understanding how tumors evade the immune response and devising strategies to reverse this process, allowing the immune system to resume its natural role in eliminating cancer cells. A Spotlight on Innovation and Expertise Shawn shares the company's bold approach, stating, "Our company only works on things that are innovative and novel. Novel drug targets and immunotherapies that haven't been proven in the clinic yet. That's a high-risk, high- reward proposition, and we've really positioned the company in that space." Expanding on this distinctive strategy, Thierry dives into the technical complexities, stating, "We decided to focus on a specific part of the immune response called innate immunity. It may be a little bit technical, but most of the companies right now are working on a specific type of cell that we call the T cells." Thierry emphasizes the company's differentiation by directing their focus toward a different facet of the immune response—innate immunity, a critical component in the early stages of the immune response. Highlighting the uniqueness that sets Kineta apart, Jacques underscores several key points. Firstly, he credits the innovative science and the essential work of Thierry and Shawn, particularly in the domain of innate immunity, as the core area of research. Secondly, he points to the exceptional experience of the management team, with Thierry's extensive background in immuno-oncology and immunology, complemented by seasoned professionals with vast experience in major pharmaceutical companies. Jacques further notes the strategic prowess of the team, citing, "The management team has demonstrated continued success, and they are the right team in place to advance KVA12123 through clinical development and to keep moving the company forward." With a background from Schering-Plough and Glaxo Smith Kline, Jacques brings his own wealth of commercial pharmaceutical experience to the table. Jacques further highlights, "Kineta is an entrepreneurial, nimble company that's been able to advance our drug programs very effectively in a capital efficient manner." This, coupled with a strong leadership team and a commitment to innovation, positions Kineta as a trailblazer in the field. Charting the Oncological Arms Race In the battle against cancer, Thierry underscores the perpetual challenge of tumors adapting and genetically modifying themselves. The dynamic nature of tumors poses Everything we do is unique. Developing immunotherapies that are differen ated is crucial for a rac ng investors today and ul mately clinicians seeking novel immunotherapies for their pa ents. ‘‘ ‘ ‘ - Jacques Bouchy
  • 17. a substantial barrier in drug development, where initial success often gives way to the tumor's ability to grow, evade and evolve. This is a frightening challenge for patients and clinicians, given tumors' remarkable mutation rates compared to normal healthy tissue. While the scientific community has achieved a breakthrough with immune checkpoint inhibitors, Thierry notes that only 20-30% of individuals treated benefit from first-generation immunotherapies. Thus, the team at Kineta remains committed in their belief that pursuing new innate immune drug targets and developing novel immunotherapies is imperative. The multi-pronged strategy involves developing new drugs, combining them with others, and persistently advancing to enhance cancer- fighting efficacy. Shawn emphasizes the importance of perseverance in this pioneering endeavor, stating, "I really think that because what we're doing is new, there's an element of determination that's really important. We have to stick with it and explore new solutions to address the medical needs of cancer patients." Refusing to accept 'no' as an answer from scientists, clinicians, investors, or regulators is a key driver, allowing the team to forge ahead and seek innovative new treatment alternatives for patients and healthcare providers. Adding a business perspective, Jacques aligns with Shawn's emphasis on perseverance, highlighting the uniqueness of Kineta's endeavors. He points out that differentiation is crucial in the marketplace for attracting investors today and ultimately clinicians seeking distinctive immunotherapies for their patients. Jacques states, "Everything we do is unique. Jacques further emphasizes the importance of differentiation in instilling confidence in patients regarding the effectiveness of new medicines. He notes, "Ultimately, patients want to have confidence that a new medicine they're going to take is going to help them achieve an improved survival outcome for their cancer." Insights from Pioneers Shawn, a seasoned entrepreneur, imparts invaluable advice for those embarking on the entrepreneurial journey, emphasizing the need for perseverance and commitment. He states, "I think that people have to understand that in order to do something really great and amazing, it takes real determination and commitment, and it doesn't happen overnight." He underscores the reality that success in developing a new drug requires overcoming numerous obstacles, and true greatness is a product of sustained effort over time. Reflecting the spirit of endurance, Thierry emphasizes the importance of optimism in the face of complexities. He acknowledges the challenges posed by intricate scientific endeavors, the need for patience in navigating difficulties, and the unpredictable nature of the market. Thierry asserts, "You have to be deeply positive and persistent to keep this program moving forward and reach success." Intrinsic positivity becomes a driving force in moving projects forward despite the inevitable hurdles and challenges that Kineta faces in the drug discovery and development process. Redefining Cancer Treatment through Unique Drug Innovation Kineta's unique identity is forged in its pursuit of pioneering innate immunity-focused drugs that possess the transformative capability to shrink tumors—a distinctive objective that sets the company apart as a trendsetter in the field of oncology. The core mission is to develop next- generation immunotherapies that transform patients' lives. Immunotherapies demonstrate efficacy to achieve tangible, unprecedented health outcomes for patients and marking a departure from conventional approaches. Emphasizing the importance of focus and resilience, the team at Kineta is persistent in their commitment to proving the efficacy of KVA12123, their lead drug program as well
  • 18. In a society heavily reliant on continuous medical advancements, the impact of new drugs and vaccines on human lives is profound, reshaping our ability to combat diseases effectively. Cancer, a significant health challenge, remains a focal point for innovation. The evolving landscape holds promise for unique and transformative approaches, offering substantial improvements in patient treatment and tangible effects on their lives. Addressing the pressing needs of individuals in the advanced stages of their cancer journey, Shawn expresses Kineta's commitment to developing new treatment options. These innovations aim to make an enormous difference for those who are running out of treatment alternatives. The mission to develop next-generation immunotherapies that transform patients' lives. As a society, the dependence on revolutionary solutions is pivotal, and Kineta envisions playing a pivotal role in this transformative journey. The success of the company is tied to the positive impact it can make on patients' lives. By consistently pushing the boundaries of what is possible in medical innovation, Kineta aspires to be a pillar of progress, providing hope and new possibilities for individuals navigating the complexities of cancer treatment. Kineta's Vision for Transformative Healthcare as the second drug program targeting CD27 that is also focused on improving cancer treatment outcomes. The aim is not only to showcase the success of each of these drug programs independently but also to demonstrate the potential of these drugs when used in combination with other cancer therapies, radiation, and surgery. Taking a tactical approach to these aspirations, the company sets specific milestones to mark its progress in drug development. One such milestone involves the release of clinical data for KVA12123, the lead asset targeting VISTA, slated for the second quarter of 2024. These key scientific updates, shared at major cancer conferences, serve as crucial checkpoints for investors, clinicians and patients, offering insights into the program's advancement. Looking ahead, Kineta outlines its phased approach, with plans to commence a phase two study in the third quarter of 2024. As the journey unfolds into 2025, the company anticipates releasing additional clinical data as both single agent therapy and in combination with other drugs that will further highlight the uniqueness and differentiation of the assets under development.
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  • 20. The landscape of oncology care has been evolving, with a growing emphasis on empowering the body's immune system to combat cancer. In recent years, researchers and healthcare professionals have delved into innovative approaches that go beyond conventional treatments. This shift towards harnessing the power of the immune system marks a significant advancement in oncology care, providing new hope for patients struggling with the complexities of cancer. Discover the transformative power of immunotherapy in cancer care – a journey towards personalized treatment and enhanced well-being awaits you! Understanding the Immune System's Role The human immune system, a formidable defense mechanism, is designed to identify and eliminate foreign invaders, including cancer cells. In oncology care, the focus is on bolstering this inherent ability to recognize and attack malignant cells. Unlike traditional therapies such as chemotherapy and radiation, which aim both healthy and cancerous cells, immunotherapy seeks to enhance the body's natural defenses, providing a more targeted and personalized approach. Immunotherapy Modalities Several modalities fall under the umbrella of immunotherapy, each designed to engage different facets of the immune system. Checkpoint inhibitors, for instance, Empowering the Immune System 18 | February 2024 www.healthcareeverything.com Best Practices in Oncology Care
  • 21. 19 | February 2024 www.healthcareeverything.com
  • 22. -Pearl Shaw block proteins that hinder immune cells from accepting and attacking cancer cells. Adoptive cell therapy involves extracting, modifying, and reintroducing a patient's immune cells to enhance their cancer-fighting capabilities. Monoclonal antibodies, another type of immunotherapy, are designed to bind to specific proteins on cancer cells, marking them for the destruction of the immune system. Combining Traditional and Immunotherapy The integration of immunotherapy with traditional treatments is becoming a hallmark of comprehensive oncology care. This approach acknowledges the strengths of both modalities, leveraging the immediate impact of conventional treatments like surgery or chemotherapy while empowering the immune system for long-term defense. The synergy between these approaches represents a dynamic shift towards a more holistic and patient-centered model of cancer care. Personalized Medicine and Biomarkers Advancements in genomic research have paved the way for personalized medicine in oncology. By analyzing the exclusive genetic makeup of a patient's tumor, healthcare professionals can tailor treatment strategies to target specific mutations driving cancer growth. Biomarkers play a crucial role in identifying individuals who are most likely to benefit from immunotherapy, enabling a more precise and effective intervention. This personalized approach not only enhances treatment efficacy but also minimizes unnecessary side effects, promoting a higher quality of life for patients. Addressing Challenges and Side Effects While immunotherapy offers promising outcomes, it is not without challenges. Adverse reactions, known as immune- related adverse events (irAEs), can occur as the immune system becomes hyperactive. Managing these side effects requires a nuanced understanding of the patient's overall health and a proactive approach to mitigate potential complications. Striking a balance between activating the immune system and preventing collateral damage remains a key consideration in optimizing immunotherapy interventions. Patient Education and Empowerment In the realm of oncology care, patient education plays a pivotal role. Empowering individuals with knowledge of their treatment options, potential side effects, and the rationale behind therapeutic decisions fosters a collaborative relationship between patients and healthcare providers. This shared decision-making process not only enhances treatment adherence but also contributes to a more positive and informed patient experience. Research Frontiers and Future Prospects Ongoing research in immunotherapy is uncovering new frontiers and expanding the arsenal of available treatments. Combination therapies, utilizing multiple immunotherapeutic agents or combining immunotherapy with other modalities, are currently under investigation. Moreover, the exploration of novel targets and the development of next-generation immunotherapies hold promise for further refining and expanding the scope of immune-based interventions. Conclusion The paradigm shift towards immunotherapy in oncology care marks a profound advancement in the fight against cancer. By harnessing the body's natural defenses, healthcare professionals are navigating uncharted territory, offering patients a more targeted and personalized approach to treatment. The integration of immunotherapy with traditional modalities, coupled with personalized medicine and ongoing research endeavors, paints a promising picture for the future of oncology care. As we continue to unravel the complexities of the immune system and its interactions with cancer, the journey towards empowering the body's defenses is a testament to the resilience of both science and the human spirit in the face of this formidable adversary. 20 | February 2024 www.healthcareeverything.com
  • 24. C ancer, a malignant disease that affects millions of lives, necessitates a thoughtful approach beyond conventional methods of treatment. It's not just about eliminating tumor cells; it's about preserving life's quality throughout the process. In this relentless pursuit of comprehensive cancer care, Sensius emerges as a source of hope and innovation. Going beyond the conventional trio of radiotherapy, chemotherapy, and immunotherapy, Sensius integrates controlled heating of deep-seated tumors into their treatment methodology. The result is not only the effective eradication of malignant cells but also a meticulous preservation of surrounding tissues and organs. The driving force behind this transformative endeavor is Paul van den Biggelaar, Co-Founder and CEO of Sensius. With rich experience spanning entrepreneurship, Sensius Radiant Hope, Revolutionary Healing healthcare, politics, and technology, Paul brings a well- rounded skill set and profound industry insight to the table. His leadership is instrumental in guiding Sensius towards its mission of enhancing the perspective for cancer patients through the innovative application of thermotherapy. In an exclusive interview with Paul, we delved into the intricate details of Sensius' approach and discovered how they are leading a transformative change in the immuno- oncology frontier. Please share about your professional background and career highlights that led you to your current position. As a former member of the Executive Team of Nucletron (now an Elekta company), world leader in brachytherapy, I was intrigued by hyperthermia, as it improves the effect of existing therapies without additional toxicity. I have studied its commercial feasibility since 2007. The work of Prof. Van Rhoon and Prof. Paulides at Erasmus University Medical Center (Rotterdam, the Netherlands) demonstrated a paradigm shift in technology and workflow. They had support letters from other universities. It was obvious to my partner and serial entrepreneur Peter van Paassen and myself that we needed to team up with Van Rhoon and Paulides to build Sensius into a company that will change the way we treat cancer. Can you provide an overview of your company and its focus on immuno-oncology? Sensius is a medical device company that provides microwave-based clinical thermotherapy solutions intended as adjuvant treatment of specific solid cancers. The Sensius system is a combination of proprietary and patented hardware, software and expert services. Sensius aspires to become the leading brand in the segment of Thermotherapy by providing the adjuvant clinical tools for the treatment of certain types of cancer. Paul Van Den Biggelaar CEO and Co-Founder Sensius 22 | February 2024 www.healthcareeverything.com
  • 25. Our thermotherapy is used in combination with radio- chemo- and immunotherapy. Thermotherapy is the next quality level in hyperthermia and provides focus and o controlled mild heating of the tumor to max 45 C. Sensius' unique and patented technology enables us to focus the heat to the tumor and protect nearby tissues from the heat. At least five different biological methods of action are triggered by this effect. The mild heating is an immunomodulator and sensitizer for radio- and chemotherapy. Research of prof. Weigelin (University of Tübingen, Germany) demonstrates that mild heating of the tumor increases T-cell killing efficiency with as much as 500%. How does your company's approach to immuno- oncology differ from other players in the field? We use 20 microwave antennas, guided by AI software and sensory data, to focus the heat to the tumor. Thermotherapy by Sensius is non-invasive and is significantly more cost effective than existing therapies. Adoption in clinics is facilitated through alignment with established radiotherapy workflow. The approach can be applied on a range of different solid tumors. Thermotherapy can be applied safely and cost-effectively without additional toxicity for patients. What are some of the challenges your company faces in the immuno-oncology field, and how are you addressing them? Many phase III studies have demonstrated the positive effects of mild heating on tumor response without additional toxicity, but current commercial solutions are not widely adopted because of substantial technical limitations which prevent robust and reproducible routine clinical use. Sensius offers improved clinical efficacy and ease-of-use and economic benefits of its thermotherapy: it is our challenge to make oncologists comfortable with this additional treatment option to the benefit of the patient (survivorship, quality of life). Healthcare payers (insurance companies, governments) will need to recognize how our economic benefits (reduced recurrence, lower cost of treatment of toxic effects, faster reintegration in society) will reduce the economic burden of cancer. What are some of the key products or therapies in your current portfolio that demonstrate your commitment to immuno-oncology? Our launching product is the FocusCollar for treatment of solid tumors in the head and neck area. This product is based on the extensive experience of Eramus University Medical Center and incorporates the experience of at least 5 more clinical research centers from all over the world. We are also part of a consortium of 4 Dutch universities to develop the FocusCup, a solution to treat breast cancer. More tumor types are on our roadmap for the future. Sensius will collaborate with clinical research centers, universities and other companies on research and clinical studies to improve quality of life and survivorship for cancer patient. Thermotherapy by Sensius is non-invasive and is significantly more cost effec ve than exis ng therapies. Trailblazing the Immuno-Oncology Fron er: Best Companies of 2024 23 | February 2024 www.healthcareeverything.com
  • 26. Can you share any innovative technologies or techniques that your company is currently exploring or implementing in its research and development efforts? Sensius uses a combination of technologies to achieve performance, ease-of-use and economic benefits. Performance to focus and control energy deposition on only the tumor is implemented through 20 microwave antennas emitting energy at a carefully selected frequency and positioned strategically around the tumor area. AI-based software calculates the exact setting for each antenna individually to protect tissues around the tumor. This secures a personalized treatment plan, which can be adapted during treatment to accommodate for the specific situation of the patient. A patented waterbolus (a flexible water container between the device and the patient) secures the transfer of the energy from the antennas into the body and makes the patient comfortable. Workflow and patient positioning are similar to radiotherapy, while a modular system architecture support the treatment of different tumor sites in the body. What are the key milestones and achievements in your company's history, particularly in the field of immuno- oncology? On our clinical prototypes, Erasmus University Medical Center has already treated over 70 patients for head and neck cancer. The results are published (Paulides et al 2016, Verduijn et al 2018, Kroesen et al 2021) and show significant benefits. Erasmus MC will start a new clinical trial in the first half of 2024 with support of Sensius. The commercial solution for head and neck cancer, the FocusCollar will be ready for commercial deployment at the end of 2025. Already over 15 clinics in Western-Europe, the UK and in the USA want to participate in multi-center international confirmation studies using the FocusCollar. How do you see the immuno-oncology market evolving in the next few years, and how is your company positioned to capitalize on these changes? Thermotherapy will improve the life of people with cancer as it offers the possibility to improve survivorship and quality of life. It can be used on multiple tumor sites in combination with radiotherapy, chemotherapy and immunotherapy. It is easy to adopt in oncology clinics and will reduce the economic burden of cancer for society. th Therefore, we believe thermotherapy will become the 4 pillar in cancer treatment. 24 | February 2024 www.healthcareeverything.com
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  • 28. Healing with Precision In the dynamic world of cancer care, immuno-oncology has emerged as a transformative force, leveraging the body's own defenses to combat the complexities of this formidable adversary. Recent breakthroughs in this field have ushered in an era of precision medicine, offering targeted treatments tailored to each patient's unique biological makeup. Discover the future of cancer care – from personalized treatments to overcoming challenges. Embrace immuno- oncology's transformative journey for hope and healing! The Foundation of Immuno-Oncology At its core, immuno-oncology utilizes the innate ability of the immune system to identify and eliminate cancer cells. Unlike traditional approaches, such as chemotherapy and radiation, which directly attack tumors, immuno-oncology focuses on enhancing the body's natural ability to recognize and eradicate malignant cells. This not only promises increased efficacy but also suggests a potential reduction in side effects compared to conventional therapies. Checkpoint Inhibitors: Releasing the Immune Response A pivotal advancement in immuno-oncology is the development of checkpoint inhibitors. These drugs block specific proteins that contribute to the immune system, enabling it to recognize and attack cancer cells more effectively. Pembrolizumab and nivolumab, prominent members of this drug class, have demonstrated remarkable success in various cancers, including melanoma and lung cancer. CAR-T Cell Therapy: A Personalized Approach Another groundbreaking avenue is CAR-T cell therapy, a personalized treatment involving the modification of a patient's immune cells to target cancer cells specifically. Beginning with the extraction of T cells from the patient's blood, genetic engineering introduces chimeric antigen receptors (CARs) that recognize cancer cells. These modified cells are then transferred into the patient. CAR-T therapy has shown promise in treating certain blood cancers, showcasing the potential of personalized immunotherapies. Monoclonal Antibodies: Precision Strikes Against Cancer Monoclonal antibodies, designed to target specific proteins on cancer cell surfaces, represent another pivotal development. By attaching to these proteins, these antibodies flag cancer cells for immune system destruction. Trastuzumab and rituximab have demonstrated success in treating breast cancer and lymphomas, highlighting the precision and efficacy of this targeted approach. Combination Therapies: Maximizing Impact Researchers are discovering the potential of combining different immuno-oncology agents to maximize impact. Combinations of checkpoint inhibitors with other immunotherapies or conventional treatments such as chemotherapy create a synergistic effect, enhancing the body's ability to recognize and eliminate cancer cells. These approaches not only improve response rates but also contribute to a more comprehensive treatment strategy. Biomarkers: Guiding Treatment Decisions In the time of precision medicine, biomarkers are essential in guiding treatment decisions. Biomarker testing allows healthcare professionals to identify specific characteristics or genetic mutations in a patient's tumor, helping determine the most effective immuno-oncology approach. This 26 | February 2024 www.healthcareeverything.com TheLatest Advances in Immuno-Oncology
  • 29. 27 | February 2024 www.healthcareeverything.com
  • 30. -Pearl Shaw personalized approach minimizes trial-and-error, ensuring patients receive interventions most likely to be beneficial for their unique cancer profile. Tumor Microenvironment: A Critical Player Understanding the tumor microenvironment is becoming increasingly crucial in immuno-oncology. The interactions between cancer cells and their surroundings can influence the effectiveness of immunotherapies. Ongoing research explores ways to modulate the tumor microenvironment, making it more receptive to immune system attacks and enhancing the overall success of immuno-oncology interventions. Patient Advocacy and Support Amidst the scientific strides, the importance of patient advocacy and support cannot be overstated. Empowering patients with information, providing emotional support, and fostering a collaborative healthcare environment contribute significantly to the overall success of immuno-oncology treatments. Active participation in patient advocacy groups and support networks helps amplify patients' voices, ensuring that their unique needs and challenges are addressed in the evolving landscape of cancer care. Precision Oncology and Artificial Intelligence Advancements in artificial intelligence (AI) are increasingly playing a role in immuno-oncology. AI algorithms analyze vast datasets, including genomic information, patient records, and treatment outcomes, to identify patterns and predict the most effective treatment strategies. This intersection of technology and medicine is paving the way for more precise and personalized cancer care, offering tailored interventions based on comprehensive data analysis. Immunotherapy in Early-Stage Cancers While immuno-oncology has shown significant success in treating advanced-stage cancers, there is a growing interest in its application in early-stage cancers. Research is underway to explore the efficacy of immunotherapy as an adjuvant or neoadjuvant treatment, aiming to eliminate residual cancer cells after surgery or to shrink tumors before surgical removal. This expansion of immuno-oncology into earlier stages of cancer holds the potential to further improve outcomes and reduce the risk of recurrence. Cost and Accessibility Despite the promise of immuno-oncology, concerns about cost and accessibility persist. These advanced therapies can be expensive, posing challenges for widespread adoption and equitable access. Researchers and policymakers are keenly addressing these issues, working towards developing more cost-effective approaches and ensuring that these cutting-edge treatments are accessible to a broader population. Challenges and Future Directions While immuno-oncology holds immense promise, challenges exist. Managing side effects, known as immune- related adverse events, requires a nuanced approach to ensure patient safety. Researchers are actively exploring ways to expand the applicability of immuno-oncology to a broader spectrum of cancers and investigating novel targets for intervention. Conclusion As we navigate this dynamic frontier of immuno-oncology, the expanding horizons bring both promise and challenges. Understanding the intricacies of the tumor microenvironment, prioritizing patient advocacy, integrating artificial intelligence for precision, exploring immunotherapy in early-stage cancers, addressing concerns about cost and accessibility, and continuing research endeavors are pivotal steps in advancing the field. The strides made in immuno-oncology are not only scientific breakthroughs but also a testament to the collaborative efforts of researchers, healthcare professionals, and advocates. Embracing these innovations and addressing challenges collectively will pave the way for a future where immuno-oncology becomes an integral part of standard cancer care, offering hope and healing with unprecedented precision. 28 | February 2024 www.healthcareeverything.com
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  • 32. here has been a vast uptick in technological Tadvancements in the laboratory industry for digital pathology and Artificial Intelligence solutions. In fact, AI is the buzzword of the day. What is the difference between algorithms, uses and accuracy? It's very easy to conflate the terminology and in some cases, the differences are very clear while in others the lines are a bit less distinguishable. In short, Artificial Intelligence (AI) and Machine Learning (ML) are closely related, but you can think of it more as a hierarchical relationship. They both relate to computers and programming; however, AI algorithms rely on human input and ML algorithms are taught. In other words, AI requires humans to provide inputs such as visual perception, interpretation, decision making, and results in algorithms that can make decisions based on data that they have been trained on. Whereas ML algorithms are based on building models, or neural networks, that are trained to identify patterns and trends in information to make decisions. ML is used to classify data and recognize patterns; this is actually essential to many AI algorithms. Image Analysis (IA) is more about extracting data for a purpose, or multiple purposes from an image. This is very useful in workflow application optimization and can provide significant added value to AI and ML, but more to digital pathology solutions and their adoption. There are two factions of thought on the overall use of these technologies in patient diagnosis and care. The first is pro- innovative technology and this group sees the benefits of being able to use well-developed, trained and tested algorithms in a variety of workflows. Some of the professionals who fall in this community are for all uses, some are for a subset and some are for a limited set of uses. The second is anti-adoption. Overall, these use cases fall into the following general categories: Diagnosis AI and ML algorithms are typically deployed for use in diagnosis. They can be used for preprocessing images to provide a pathologist with an interpretation of the specimen. This can include the image which typically overlays on the original and shows a 'hot spot' view of the cancer within that slide and can also provide textual and contextual data i.e.: percentage of proliferation, grade of cancer, number of positive and negative cells, etc. This type of algorithm can often be used as a region of interest (ROI) that is manually invoked by the pathologist on a slide or area of a slide that they are looking for more insight on. When integrated within a digital pathology solution, this can also provide a streamlined workflow to include capturing the image and output to include in a final report in support of the pathologist's diagnosis. These algorithms can be used (if FDA cleared for diagnosis or validated as an LDT by the laboratory/pathologist) as diagnostic or as an aid to the pathologist in rendering their diagnosis. Workflow Optimization IA algorithms provide a streamlined workflow through the preprocessing analysis of images. These algorithms can perform such tasks as auto registration of images, ensuring that the images in a virtual slide tray are in the correct order, analyzing images to make a priority assessment and move cases with a higher probability of being positive, or more complex, higher in the pathologist's worklist. 30 | February 2024 www.healthcareeverything.com
  • 33. For more than 2 decades, Lisa-Jean Clifford has been a noteworthy leader in the high-tech healthcare solu ons space. Lisa-Jean's passion for making a posi ve impact on the lives of pa ents through technology can be traced back to her tenure at McKesson and IDX, now GE Healthcare, where she served in vital business development and marke ng roles and to Psyche Systems, an LIS solu on provider, where she was the CEO for eleven years. Now, recognized as an industry expert, she ac vely par cipates in numerous boards including the Associa on of Pathology Informa cs and MLO's Editorial Advisory Board. She is widely published in many top laboratory publica ons and noteworthy news sources, such as Forbes, CAP Today, Medical Laboratory Observer, and Health Data Management. Also, she is a highly sought-a er speaker and focuses on delivering valuable content in cri cal areas such as lab automa on including so ware and interoperability, digital pathology, AI in pathology, lab informa cs, oncology, and women's health. Lisa-Jean's success can be a ributed to her perseverance, integrity, her high-regard for ethics, and her desire to con nue to learn, grow, and move technology solu ons in a forward direc on for healthcare. Her collabora on with industry partners, customers, colleagues, and compe tors combined with her commitment to excep onal customer rela onships is what dis nguishes her drive to foster a win- win for the healthcare industry as a whole. Algorithms also contribute to significant efficiency and accuracy gains in use by pathologists. They can perform calculations and computational work that software can do exponentially faster than a human. This also removes the need for tedious, manual tasks to be performed by high- quality resources, such as pathologists, and affords them the ability to focus on their expertise, the interpretation and diagnosis of the patient. Quality Assurance or Control Algorithms can also be configured, or deployed, to provide either an automatic review of all cases or be set to do a review of a predetermined number or percentage of cases to support regulatory requirements for review or for internal training and safety. In this use case, the algorithms would be run either before a case is signed out, but after it is diagnosed, or after it is signed out to flag any questionable diagnosis. It can highlight areas that may have been missed, flag a tumor that may have been identified as a grade 2 when it was determined to be a 4 by the algorithm, etc. The second set of professionals in this community are not bought into the safety or use of algorithms in diagnostic practice. There is the argument that many of these are not fully tested, they are not able to be used "out of the box" for a variety of reasons leading to a wide variation in how images are viewed (color saturation, stain types, scanner file formats, etc.). Many of the algorithms are rated on their accuracy by a correlation factor and pathologists are not always in concordance with themselves 100% of the time, never mind with each other. Then, there is the concern that drift results can occur. Recently, Fortune reported that a study conducted by Stanford University found that "Over just a few months, ChatGPT went from correctly answering a simple math problem 98% of the time to just 2%". While this is not indicative of what a commercially available, tested pathology algorithm would encounter, it does add to the doubt of those who are in this community of adaptors. In summary, algorithms, when tested and validated by each laboratory for deployment within a digital workflow solution can provide improved efficiency, streamlined workflow, reduce errors and increase the experience for the pathologist. 31 | February 2024 www.healthcareeverything.com
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