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COMPANY OVERVIEW &
PLATFORM TECHNOLOGIES
IMMUNOMODULATORY STEM CELL THERAPY FOR CANCER
mRNA-NANOPARTICLE CANCER VACCINES
2
Immune checkpoint inhibitors (ICIs)
take the “brakes” off the immune
system and have transformed cancer
therapy. However, over two-thirds of
patients treated with ICIs do not
respond to treatment.
Through our preclinical studies, we have
found that the resistance to ICIs can be
overcome through an intravenously (IV)
delivered stem cell therapy. We have also
developed potent RNA-NPs that reprogram
the immunosuppressive tumor
microenvironments and turn “cold” tumors
into “hot” tumors.
Our mRNA-NP vaccine platform has entered
early phase clinical trials in refractory solid
cancers, and our stem cell therapeutic has
received FDA approval to initiate clinical
studies in patients with GBM. Capitalization
for clinical trial evaluation and development
of allogeneic ‘off-the-shelf’ stem cell
therapies is sought.
iONCOLOGi IN BRIEF
iOncologi, Inc. is a biotechnology ‘spin-out’ company from the University of Florida focused on the advancement of novel
cancer immunotherapies for refractory solid tumors.
We have discovered specialized stem cell therapies (iOi7, iOi8,) that overcome resistance to immune checkpoint inhibitors
(ICIs) and restore exhausted adaptive immune responses. We have developed proprietary RNA-nanoparticle vaccines (iOi9)
that reprogram immunosuppressive tumor microenvironments in multiple cancers.
3
PUBLISHED DATA ON OUR STEM CELL IMMUNOTHERAPY
4
PUBLISHED DATA ON OUR RNA NANOPARTICLE VACCINES
5
THE PROBLEM IN DEPTH
The Challenges of
Immune Checkpoint
Inhibitor (ICI) Resistance
Turning “Cold” Tumors
“Hot”
More than 2/3 of patients treated with ICIs
do not respond positively and still suffer the
risks of toxicity and the financial burden
of therapy.
In cold tumors characterized by low mutational
burden, a scarcity of immunoreactive T
lymphocytes, and an abundance of
immunosuppressive myeloid cells, effective
immunotherapeutic approaches must confront
these challenges to enhance immune responses.
iOncologi's treatment proprietary approach has
demonstrated significant success in
reprogramming the immune microenvironment
over time. This reprogramming leads to robust
and sustained immunologic attacks against
multiple refractory cancers, including primary and
metastatic brain cancers, as well as refractory
solid tumors such as non-small cell lung cancer
(NSCLC), colorectal, breast cancer, and sarcoma.
Despite multiple primary indications approved
for ICI therapy, many “cold” “solid tumors do
not respond to immunotherapy at all.
iOncologi’s technologies are aimed at
addressing the unmet need of treatment of
refractory solid cancers.
6
OUR SOLUTION
We have discovered specialized stem cell therapies that overcome complete resistance to ICIs and
activate potent immune responses (iOi7, iOi8) and have exclusivity to novel mRNA vaccines (iOi9)
that are effective against multiple tumor types.
We plan to follow a development and
clinical evaluation pathway that has
been used successfully by iOncologi’s
founders to advance six novel biologic
therapies into first-in-human studies in
adult and pediatric patients.
The treatments are delivered
intravenously, with stem cells traveling
to sites of invasive tumor growth and
reprogramming the suppressive tumor
microenvironment, and mRNA
vaccines acting as systemic modifiers
of anti-tumor immunity. This process
converts resistant cancers to tumors
that potently respond to ICI treatment.
7
THE LEADERSHIP TEAM
Duane A. Mitchell, M.D., Ph.D.
Founder and President
Chairman, Board of Directors
A leader in the field of brain tumor immunotherapy. Dr. Duane Mitchell
has pioneered the development of several novel therapeutics for brain
tumors and holds numerous patents related to his work. His work in
advancing brain tumor immunotherapy for glioblastoma was recognized
as one of the Top 10 Clinical Research Achievements by the Clinical
Research Forum in Washington, D.C. in 2016. Dr. Mitchell also leads the
UF Brain Tumor Immunotherapy Program (UFBTIP) at the Preston A.
Wells, Jr. Center for Brain Tumor Therapy at University of Florida. He has
secured over $40 million in research funding to support immunotherapy
development, including grants from the NIH, Department of Defense,
and private foundations.
Catherine Flores, Ph.D.
Co-Founder & Stem Cell Biologist
Member, Board of Directors
Dr. Catherine Flores is an accomplished researcher who received her
Ph.D. in stem cell biology from the Imperial College​
of London. She currently serves as the Principal Investigator of the Stem
Cell Engineering Lab within the UF Brain Tumor Immunotherapy
Program. Dr. Flores' pioneering work has uncovered new insights into
the novel role of stem cells in modulating immune responses​ and has
revealed exciting new therapeutic opportunities. Dr. Flores has received
over $3M in funding from the NIH to investigate the novel use of stem
cells in the immunotherapeutic treatment of malignant brain tumors.
Her innovative work has resulted in several high-impact publications that
describe this exciting new area of research. ​
8
THE LEADERSHIP TEAM
Peter Kash, Ed.D., M.B.A.
Member, Board of Directors
Dr. Peter Kash is a highly experienced entrepreneur and biotech
industry leader. He is the Co-founder and Vice-Chairman of TargImmune
Therapeutics , a biotech company based in Switzerland that is
developing innovative cancer immunotherapies. With over 30 years of
experience in the biotech sector, Dr. Kash has co-founded more than a
dozen biotech companies and has co-raised over $2B in private
financings. Seven drugs that he has been involved with have reached
FDA approval from pre-clinical status. Dr. Kash has lectured on
healthcare-related topics and entrepreneurship in over 60 countries
around the world. In 2019, Dr. Kash gave a TEDx talk in London on
"Entrepreneurship in the Age of Millennials”. His wealth of experience
and knowledge make him a valuable leader in the biotech industry.
Lan Hoang-Minh, M.Eng., PhD.
Associate Director
Dr. Lan Hoang-Minh has over 10 years of experience in cancer research,
including project management as well as recruitment and supervision of
laboratory personnel. Prior to joining iOncologi, she served as a Research
Assistant Professor in the Brain Tumor Immunotherapy Program within the
University of Florida Lillian S. Wells Department of Neurosurgery. In this
capacity, Dr. Hoang-Minh concentrated on the development of research
tools and models and the advancement of innovative immunotherapy
strategies targeting malignant brain tumors. Her research, conducted under
the expert guidance of Dr. Duane Mitchell, was generously supported by
various foundation grants. Dr. Hoang-Minh earned both a Master of
Engineering and a Ph.D. in biomedical engineering from the University of
Florida.
9
INTELLECTUAL PROPERTY AND SECRET SAUCE
iOncologi has exclusivity to the stem cell immunotherapy platform developed at the
University of Florida
US Patent Application Number 17/748,284,
granted 5/26/2020, titled ‘Hematopoietic
Stem Cells in Combinatorial Therapy with
Immune Checkpoint Inhibitors Against
Cancer’, invented by Duane Mitchell, MD,
PhD, and Catherine Flores, PhD; and related
applications (U.S. patent issued, ,
international patent rights issued and
pending)
PCT Application Number
PCT/US2017/067914, published 6/28/2018,
entitled ‘CCR2+ Hematopoietic Stem Cells
Mediate T Cell Activation in Adoptive Cell
Therapy’, invented by Duane Mitchell, MD,
PhD and Catherine Flores, PhD (U.S. patent
issued, international patent rights issued
and pending)
FDA Investigational New Drug (IND) application for first-in-human application in glioblastoma
has been approved at University of Florida (FDA IND BB-21102; PI: Mitchell)
10
ADDITIONAL PLATFORM TECHNOLOGIES
iOncologi has additional exclusive rights to novel mRNA nanoparticle vaccines that have
entered clinical phase evaluation in patients with malignant gliomas
US PCT Application Number
PCT/US2019/046618, published 02/20/20,
entitled ‘Methods of sensitizing tumors to
treatment with immune checkpoint
inhibitors’, invented by Elias Sayour, MD, PhD
and Duane Mitchell, MD, PhD; and related
applications (U.S. and worldwide patent
rights filed).
PCT Application Number
PCT/US2017/053691, published 03/18/21,
entitled ‘Magnetic liposomes and related
treatment and imaging methods’, invented
by Adam Grippin, MD, PhD, et al., (U.S. and
worldwide patent rights filed).
FDA Investigational New Drug (IND) application for first-in-human application of mRNA
nanoparticle vaccines in refractory cancers has been issued and trial open to accrual
(FDA IND 19304 and clinicaltrials.gov NCT04573140)
11
BUSINESS OR REVENUE MODEL
Revenue Source
iOncologi will focus on the manufacturing
and delivery of stem cell products that are
effective in combination with ICIs and the
effective targeting of refractory solid
tumors with proprietary mRNA
nanoparticle vaccines.
Channels
Distribution is planned through existing
accredited cell therapy clinics in an
outpatient setting and oncologists in
prescribing treatment centers.
Partnerships
Strategic alignment with ICI suppliers and
other I-O companies that may enhance
iOncologi’s therapeutic platforms are
actively being sought.
Primary Customer
Oncologists treating patients with
advanced cancer and medical treatment
centers. The treatments are reimbursed
through health insurance.
12
RISKS AND HOW THEY WILL BE MITIGATED
IMMUNOMODULATORY STEM CELLS
Mitigation
iOi’s stem cell technology is also being evaluated in
combination with other dedicated treatments.
Since iOncologi’s stem cell technology is able to reprogram
the immunosuppressive tumor’s environment, it could be
applied in multiple cancers and in combination with
multiple immunotherapy platforms.
iOi’s stem cell technology is being evaluated for
effectiveness in other cancers with significant resistant
patient populations, such as breast and lung cancers.
iOi will leverage existing infrastructure
and expertise within transplant centers for collection
and distribution, as well as established reimbursement
and pricing models for stem cell therapeutics.
Centralized cGMP manufacturing costs for the isolation
and expansion of the stem cell products will be
incorporated.
Cell therapies face risks due to complexity and costs of scale-up manufacturing,
consistency in product activity, and logistical and distribution challenges.
13
RISKS AND HOW THEY WILL BE MITIGATED
RNA NANOPARTICLE VACCINES
Mitigation
The mRNA NP vaccine platform to which iOi maintains
exclusive rights is synergistic with other I-O platforms (T cell
therapy, checkpoint inhibitors) and thus offers innovative
and unique combinatorial treatment opportunities within
iOi’s pipeline.
The mRNA-NP platform, similarly to the
immunomodulatory stem cells, is broadly applicable and
effective in multiple tumor types, offering several
populations of cancer patients that may benefit from this
novel therapy and a broad array of potential indications.
iOi’s exclusive mRNA NP platform has entered clinical
stage evaluation in adults and children with malignant
gliomas and has received funding at UF for evaluation
in multiple refractory solid tumors.
Proprietary formulation for optimized mRNA delivery and
immunologic reprogramming of the tumor
microenvironment uniquely positions iOi in the mRNA
vaccine space.
mRNA vaccines have shown considerable promise in inducing potent immunologic
responses and a favorable safety profile in humans. Industry competition is steep for
development of therapeutic mRNA cancer vaccines.
Ongoing studies in veterinary oncology setting provides de-
risked preclinical platform for drug development and
additional potential market.
14
iOncologi founders were able
to develop a stem cell therapy
that can overcome ICI resistance in
malignant brain tumors and
obtained exclusive rights to novel
mRNA nanoparticle vaccines for
cancer.
With strong ties to leading academic
health systems, iOi can rapidly
convert findings into early phase
clinical trials in patients with solid
tumors that have inherent or
acquired resistance to conventional
immunotherapies.
SUMMARY
iOi has assembled expertise
in immuno-oncology and
biopharmaceutical development to
advance
these therapeutic platforms, which
have reached clinical stage of
evaluation.
iOi is in a unique position
to introduce a new class of biologics
in the field of immuno-oncology
where the approach is applicable
to multiple types of cancer
and ICI pathways.
THANK YOU
For additional information, contact:
Duane A. Mitchell, MD, PhD
President & Chair, iOncologi, Inc.
The Hub at Innovation Square
747 SW 2nd Avenue
Gainesville, FL 32601
dmitchell@ioncologi.com
(352) 559-5100
APPENDIX
*technical information
Immunomodulatory
Stem Cell Therapy
18
HSCs Migrate to Areas of Intracranial Tumor Growth and
Recruit Tumor-Infiltrating Lymphocytes
Mice bearing intracranial gliomas received intravenous transfer of tumor-specific T lymphocytes from syngeneic GFP transgenic
mice with or without HSC transfer from DsRed transgenic mice, allowing the in vivo evaluation of T cell (green) and HSC (red)
trafficking to CNS tumors. Given the co-localization of HSC-derived cells and tumor-specific T cells observed in brain tumors, we
evaluated the impact of HSC transfer on lymphocyte infiltration into CNS gliomas. Enumeration of the number of GFP+ T cells
within the tumor microenvironment demonstrated that HSC transfer resulted in a profound increase in T lymphocytes within
malignant gliomas (Flores C and Mitchell DA et al., OncoImmunology, 2015).
19
HSCs Synergize with Anti-PD-1 Blockade to Restore Response in
Refractory Glioblastoma, Medulloblastoma, and Brain Stem Glioma
0 2 0 4 0 6 0 8 0
0
5 0
1 0 0
D a y s s u rv iv a l
P
e
r
c
e
n
t
s
u
r
v
iv
a
l
T u m o r o n ly
H S C T h e ra p y
P D -1 o n ly
H S C T h e ra p y + P D -1
0 2 0 4 0 6 0
0
5 0
1 0 0
Tim e
P
e
r
c
e
n
t
s
u
r
v
iv
a
l
T u m o r o n ly
A n ti-P D -1 o n ly
H S C o n ly
A n ti-P D 1 + H S C
Nf1+/- p53+/-
GBM
Ptch+/-
SHH MB
K27M DIPG
Treatment of immunocompetent murine GBM (upper left),
Sonic Hedgehog medulloblastoma (upper right), or
histone 3.3 mutant brain stem glioma models with HSC
therapy alone or PD-1 blockade alone demonstrates
complete resistance to treatment. However, the
combination of HSCs + anti-PD-1 reverses resistance to
immune checkpoint blockade in all three models and
reveals synergistic extension of survival and long-term
cures in 20-50% of mice with GBM or medulloblastoma.
These studies have been confirmed in multiple repeated
experiments (Flores C, Mitchell DA, et al., Nature
Communications, 2018).
20
Specialized HSC subsets overcome resistance to PD-1 blockade.
Mice bearing intracranial gliomas received intravenous infusion of unfractionated lineage negative HSCs or purified subsets of
HSCs in combination with anti-PD-1 antibodies. A particular subset of HSCs (Subset B) demonstrated marked enhancement of
the efficacy of immune checkpoint blockade in mice with invasive gliomas (Flores C and Mitchell DA, et al., Nature
Communications, 2018).
RNA Nanoparticle Vaccines
22
RNA-NANOPARTICLE VACCINES
Personalized RNA-NP vaccines targeting tumor antigens
result in systemic activation of innate and adaptive
immune system as well as reprogramming of the tumor
microenvironment from immunosuppressive (“cold”) to
immune stimulatory (“hot”).
23
Multi-lamellar RNA-NPs elicit long-term memory recall responses, decrease
immunosuppressive macrophages (TAMs) and myeloid-derived suppressor cells (MDSCs) and
increase activated dendritic cells (DCs) in the tumor microenvironment
Efficacy demonstrated in
immunocompetent brain stem
glioma (K7M2) and melanoma
(B16F10) models
24
RNA-NPs mediate anti-tumor efficacy against immunologically cold tumors
25
RNA-NPs have significant capacity for enhancement through co-packaging of
modulatory mRNAs/siRNAs
Enhanced anti-tumor efficacy demonstrated by co-delivery of mRNA encoding for GM-CSF (left)
or siRNA to PD-L1 (right) demonstrating versatility of the RNA-NP platform.
26
Veterinary Clinical Trials in Spontaneous Cancer
27
Rapid Immune Activation in Canines with Brain Cancer using RNA-NP vaccines
28
Promising survival outcomes in canines (n=5) with terminal
gliomas receiving RNA-NPs
Mean Survival: Foster ES et al. J Vet Intern Med. 1988;2(2):71-4
Median Survival: Pluhar et al. Vaccine. 2010 Apr 26;28(19):3371-8
29
FDA-approved clinical trial of mRNA-NP vaccines in newly diagnosed
adult GBM & pediatric high-grade gliomas
First-in-human clinical trial approved by FDA for mRNA-NP
vaccines targeting newly-diagnosed pediatric high-grade
gliomas and adult GBM
Phase 1 dose-escalation study in adults at UF with national
Phase 2 study in pediatric HGGs through PNOC consortium
PNOC-020 (Study Chair: Elias Sayour, MD, PhD)
FDA IND BB-19304
Open for enrollment
THANK YOU
For additional information, contact:
Duane A. Mitchell, MD, PhD
President & Chair, iOncologi, Inc.
The Hub at Innovation Square
747 SW 2nd Avenue
Gainesville, FL 32601
dmitchell@ioncologi.com
(352) 559-5100

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iOncologi_Pitch Deck_2024 slide show for hostinger

  • 1. COMPANY OVERVIEW & PLATFORM TECHNOLOGIES IMMUNOMODULATORY STEM CELL THERAPY FOR CANCER mRNA-NANOPARTICLE CANCER VACCINES
  • 2. 2 Immune checkpoint inhibitors (ICIs) take the “brakes” off the immune system and have transformed cancer therapy. However, over two-thirds of patients treated with ICIs do not respond to treatment. Through our preclinical studies, we have found that the resistance to ICIs can be overcome through an intravenously (IV) delivered stem cell therapy. We have also developed potent RNA-NPs that reprogram the immunosuppressive tumor microenvironments and turn “cold” tumors into “hot” tumors. Our mRNA-NP vaccine platform has entered early phase clinical trials in refractory solid cancers, and our stem cell therapeutic has received FDA approval to initiate clinical studies in patients with GBM. Capitalization for clinical trial evaluation and development of allogeneic ‘off-the-shelf’ stem cell therapies is sought. iONCOLOGi IN BRIEF iOncologi, Inc. is a biotechnology ‘spin-out’ company from the University of Florida focused on the advancement of novel cancer immunotherapies for refractory solid tumors. We have discovered specialized stem cell therapies (iOi7, iOi8,) that overcome resistance to immune checkpoint inhibitors (ICIs) and restore exhausted adaptive immune responses. We have developed proprietary RNA-nanoparticle vaccines (iOi9) that reprogram immunosuppressive tumor microenvironments in multiple cancers.
  • 3. 3 PUBLISHED DATA ON OUR STEM CELL IMMUNOTHERAPY
  • 4. 4 PUBLISHED DATA ON OUR RNA NANOPARTICLE VACCINES
  • 5. 5 THE PROBLEM IN DEPTH The Challenges of Immune Checkpoint Inhibitor (ICI) Resistance Turning “Cold” Tumors “Hot” More than 2/3 of patients treated with ICIs do not respond positively and still suffer the risks of toxicity and the financial burden of therapy. In cold tumors characterized by low mutational burden, a scarcity of immunoreactive T lymphocytes, and an abundance of immunosuppressive myeloid cells, effective immunotherapeutic approaches must confront these challenges to enhance immune responses. iOncologi's treatment proprietary approach has demonstrated significant success in reprogramming the immune microenvironment over time. This reprogramming leads to robust and sustained immunologic attacks against multiple refractory cancers, including primary and metastatic brain cancers, as well as refractory solid tumors such as non-small cell lung cancer (NSCLC), colorectal, breast cancer, and sarcoma. Despite multiple primary indications approved for ICI therapy, many “cold” “solid tumors do not respond to immunotherapy at all. iOncologi’s technologies are aimed at addressing the unmet need of treatment of refractory solid cancers.
  • 6. 6 OUR SOLUTION We have discovered specialized stem cell therapies that overcome complete resistance to ICIs and activate potent immune responses (iOi7, iOi8) and have exclusivity to novel mRNA vaccines (iOi9) that are effective against multiple tumor types. We plan to follow a development and clinical evaluation pathway that has been used successfully by iOncologi’s founders to advance six novel biologic therapies into first-in-human studies in adult and pediatric patients. The treatments are delivered intravenously, with stem cells traveling to sites of invasive tumor growth and reprogramming the suppressive tumor microenvironment, and mRNA vaccines acting as systemic modifiers of anti-tumor immunity. This process converts resistant cancers to tumors that potently respond to ICI treatment.
  • 7. 7 THE LEADERSHIP TEAM Duane A. Mitchell, M.D., Ph.D. Founder and President Chairman, Board of Directors A leader in the field of brain tumor immunotherapy. Dr. Duane Mitchell has pioneered the development of several novel therapeutics for brain tumors and holds numerous patents related to his work. His work in advancing brain tumor immunotherapy for glioblastoma was recognized as one of the Top 10 Clinical Research Achievements by the Clinical Research Forum in Washington, D.C. in 2016. Dr. Mitchell also leads the UF Brain Tumor Immunotherapy Program (UFBTIP) at the Preston A. Wells, Jr. Center for Brain Tumor Therapy at University of Florida. He has secured over $40 million in research funding to support immunotherapy development, including grants from the NIH, Department of Defense, and private foundations. Catherine Flores, Ph.D. Co-Founder & Stem Cell Biologist Member, Board of Directors Dr. Catherine Flores is an accomplished researcher who received her Ph.D. in stem cell biology from the Imperial College​ of London. She currently serves as the Principal Investigator of the Stem Cell Engineering Lab within the UF Brain Tumor Immunotherapy Program. Dr. Flores' pioneering work has uncovered new insights into the novel role of stem cells in modulating immune responses​ and has revealed exciting new therapeutic opportunities. Dr. Flores has received over $3M in funding from the NIH to investigate the novel use of stem cells in the immunotherapeutic treatment of malignant brain tumors. Her innovative work has resulted in several high-impact publications that describe this exciting new area of research. ​
  • 8. 8 THE LEADERSHIP TEAM Peter Kash, Ed.D., M.B.A. Member, Board of Directors Dr. Peter Kash is a highly experienced entrepreneur and biotech industry leader. He is the Co-founder and Vice-Chairman of TargImmune Therapeutics , a biotech company based in Switzerland that is developing innovative cancer immunotherapies. With over 30 years of experience in the biotech sector, Dr. Kash has co-founded more than a dozen biotech companies and has co-raised over $2B in private financings. Seven drugs that he has been involved with have reached FDA approval from pre-clinical status. Dr. Kash has lectured on healthcare-related topics and entrepreneurship in over 60 countries around the world. In 2019, Dr. Kash gave a TEDx talk in London on "Entrepreneurship in the Age of Millennials”. His wealth of experience and knowledge make him a valuable leader in the biotech industry. Lan Hoang-Minh, M.Eng., PhD. Associate Director Dr. Lan Hoang-Minh has over 10 years of experience in cancer research, including project management as well as recruitment and supervision of laboratory personnel. Prior to joining iOncologi, she served as a Research Assistant Professor in the Brain Tumor Immunotherapy Program within the University of Florida Lillian S. Wells Department of Neurosurgery. In this capacity, Dr. Hoang-Minh concentrated on the development of research tools and models and the advancement of innovative immunotherapy strategies targeting malignant brain tumors. Her research, conducted under the expert guidance of Dr. Duane Mitchell, was generously supported by various foundation grants. Dr. Hoang-Minh earned both a Master of Engineering and a Ph.D. in biomedical engineering from the University of Florida.
  • 9. 9 INTELLECTUAL PROPERTY AND SECRET SAUCE iOncologi has exclusivity to the stem cell immunotherapy platform developed at the University of Florida US Patent Application Number 17/748,284, granted 5/26/2020, titled ‘Hematopoietic Stem Cells in Combinatorial Therapy with Immune Checkpoint Inhibitors Against Cancer’, invented by Duane Mitchell, MD, PhD, and Catherine Flores, PhD; and related applications (U.S. patent issued, , international patent rights issued and pending) PCT Application Number PCT/US2017/067914, published 6/28/2018, entitled ‘CCR2+ Hematopoietic Stem Cells Mediate T Cell Activation in Adoptive Cell Therapy’, invented by Duane Mitchell, MD, PhD and Catherine Flores, PhD (U.S. patent issued, international patent rights issued and pending) FDA Investigational New Drug (IND) application for first-in-human application in glioblastoma has been approved at University of Florida (FDA IND BB-21102; PI: Mitchell)
  • 10. 10 ADDITIONAL PLATFORM TECHNOLOGIES iOncologi has additional exclusive rights to novel mRNA nanoparticle vaccines that have entered clinical phase evaluation in patients with malignant gliomas US PCT Application Number PCT/US2019/046618, published 02/20/20, entitled ‘Methods of sensitizing tumors to treatment with immune checkpoint inhibitors’, invented by Elias Sayour, MD, PhD and Duane Mitchell, MD, PhD; and related applications (U.S. and worldwide patent rights filed). PCT Application Number PCT/US2017/053691, published 03/18/21, entitled ‘Magnetic liposomes and related treatment and imaging methods’, invented by Adam Grippin, MD, PhD, et al., (U.S. and worldwide patent rights filed). FDA Investigational New Drug (IND) application for first-in-human application of mRNA nanoparticle vaccines in refractory cancers has been issued and trial open to accrual (FDA IND 19304 and clinicaltrials.gov NCT04573140)
  • 11. 11 BUSINESS OR REVENUE MODEL Revenue Source iOncologi will focus on the manufacturing and delivery of stem cell products that are effective in combination with ICIs and the effective targeting of refractory solid tumors with proprietary mRNA nanoparticle vaccines. Channels Distribution is planned through existing accredited cell therapy clinics in an outpatient setting and oncologists in prescribing treatment centers. Partnerships Strategic alignment with ICI suppliers and other I-O companies that may enhance iOncologi’s therapeutic platforms are actively being sought. Primary Customer Oncologists treating patients with advanced cancer and medical treatment centers. The treatments are reimbursed through health insurance.
  • 12. 12 RISKS AND HOW THEY WILL BE MITIGATED IMMUNOMODULATORY STEM CELLS Mitigation iOi’s stem cell technology is also being evaluated in combination with other dedicated treatments. Since iOncologi’s stem cell technology is able to reprogram the immunosuppressive tumor’s environment, it could be applied in multiple cancers and in combination with multiple immunotherapy platforms. iOi’s stem cell technology is being evaluated for effectiveness in other cancers with significant resistant patient populations, such as breast and lung cancers. iOi will leverage existing infrastructure and expertise within transplant centers for collection and distribution, as well as established reimbursement and pricing models for stem cell therapeutics. Centralized cGMP manufacturing costs for the isolation and expansion of the stem cell products will be incorporated. Cell therapies face risks due to complexity and costs of scale-up manufacturing, consistency in product activity, and logistical and distribution challenges.
  • 13. 13 RISKS AND HOW THEY WILL BE MITIGATED RNA NANOPARTICLE VACCINES Mitigation The mRNA NP vaccine platform to which iOi maintains exclusive rights is synergistic with other I-O platforms (T cell therapy, checkpoint inhibitors) and thus offers innovative and unique combinatorial treatment opportunities within iOi’s pipeline. The mRNA-NP platform, similarly to the immunomodulatory stem cells, is broadly applicable and effective in multiple tumor types, offering several populations of cancer patients that may benefit from this novel therapy and a broad array of potential indications. iOi’s exclusive mRNA NP platform has entered clinical stage evaluation in adults and children with malignant gliomas and has received funding at UF for evaluation in multiple refractory solid tumors. Proprietary formulation for optimized mRNA delivery and immunologic reprogramming of the tumor microenvironment uniquely positions iOi in the mRNA vaccine space. mRNA vaccines have shown considerable promise in inducing potent immunologic responses and a favorable safety profile in humans. Industry competition is steep for development of therapeutic mRNA cancer vaccines. Ongoing studies in veterinary oncology setting provides de- risked preclinical platform for drug development and additional potential market.
  • 14. 14 iOncologi founders were able to develop a stem cell therapy that can overcome ICI resistance in malignant brain tumors and obtained exclusive rights to novel mRNA nanoparticle vaccines for cancer. With strong ties to leading academic health systems, iOi can rapidly convert findings into early phase clinical trials in patients with solid tumors that have inherent or acquired resistance to conventional immunotherapies. SUMMARY iOi has assembled expertise in immuno-oncology and biopharmaceutical development to advance these therapeutic platforms, which have reached clinical stage of evaluation. iOi is in a unique position to introduce a new class of biologics in the field of immuno-oncology where the approach is applicable to multiple types of cancer and ICI pathways.
  • 15. THANK YOU For additional information, contact: Duane A. Mitchell, MD, PhD President & Chair, iOncologi, Inc. The Hub at Innovation Square 747 SW 2nd Avenue Gainesville, FL 32601 dmitchell@ioncologi.com (352) 559-5100
  • 18. 18 HSCs Migrate to Areas of Intracranial Tumor Growth and Recruit Tumor-Infiltrating Lymphocytes Mice bearing intracranial gliomas received intravenous transfer of tumor-specific T lymphocytes from syngeneic GFP transgenic mice with or without HSC transfer from DsRed transgenic mice, allowing the in vivo evaluation of T cell (green) and HSC (red) trafficking to CNS tumors. Given the co-localization of HSC-derived cells and tumor-specific T cells observed in brain tumors, we evaluated the impact of HSC transfer on lymphocyte infiltration into CNS gliomas. Enumeration of the number of GFP+ T cells within the tumor microenvironment demonstrated that HSC transfer resulted in a profound increase in T lymphocytes within malignant gliomas (Flores C and Mitchell DA et al., OncoImmunology, 2015).
  • 19. 19 HSCs Synergize with Anti-PD-1 Blockade to Restore Response in Refractory Glioblastoma, Medulloblastoma, and Brain Stem Glioma 0 2 0 4 0 6 0 8 0 0 5 0 1 0 0 D a y s s u rv iv a l P e r c e n t s u r v iv a l T u m o r o n ly H S C T h e ra p y P D -1 o n ly H S C T h e ra p y + P D -1 0 2 0 4 0 6 0 0 5 0 1 0 0 Tim e P e r c e n t s u r v iv a l T u m o r o n ly A n ti-P D -1 o n ly H S C o n ly A n ti-P D 1 + H S C Nf1+/- p53+/- GBM Ptch+/- SHH MB K27M DIPG Treatment of immunocompetent murine GBM (upper left), Sonic Hedgehog medulloblastoma (upper right), or histone 3.3 mutant brain stem glioma models with HSC therapy alone or PD-1 blockade alone demonstrates complete resistance to treatment. However, the combination of HSCs + anti-PD-1 reverses resistance to immune checkpoint blockade in all three models and reveals synergistic extension of survival and long-term cures in 20-50% of mice with GBM or medulloblastoma. These studies have been confirmed in multiple repeated experiments (Flores C, Mitchell DA, et al., Nature Communications, 2018).
  • 20. 20 Specialized HSC subsets overcome resistance to PD-1 blockade. Mice bearing intracranial gliomas received intravenous infusion of unfractionated lineage negative HSCs or purified subsets of HSCs in combination with anti-PD-1 antibodies. A particular subset of HSCs (Subset B) demonstrated marked enhancement of the efficacy of immune checkpoint blockade in mice with invasive gliomas (Flores C and Mitchell DA, et al., Nature Communications, 2018).
  • 22. 22 RNA-NANOPARTICLE VACCINES Personalized RNA-NP vaccines targeting tumor antigens result in systemic activation of innate and adaptive immune system as well as reprogramming of the tumor microenvironment from immunosuppressive (“cold”) to immune stimulatory (“hot”).
  • 23. 23 Multi-lamellar RNA-NPs elicit long-term memory recall responses, decrease immunosuppressive macrophages (TAMs) and myeloid-derived suppressor cells (MDSCs) and increase activated dendritic cells (DCs) in the tumor microenvironment Efficacy demonstrated in immunocompetent brain stem glioma (K7M2) and melanoma (B16F10) models
  • 24. 24 RNA-NPs mediate anti-tumor efficacy against immunologically cold tumors
  • 25. 25 RNA-NPs have significant capacity for enhancement through co-packaging of modulatory mRNAs/siRNAs Enhanced anti-tumor efficacy demonstrated by co-delivery of mRNA encoding for GM-CSF (left) or siRNA to PD-L1 (right) demonstrating versatility of the RNA-NP platform.
  • 26. 26 Veterinary Clinical Trials in Spontaneous Cancer
  • 27. 27 Rapid Immune Activation in Canines with Brain Cancer using RNA-NP vaccines
  • 28. 28 Promising survival outcomes in canines (n=5) with terminal gliomas receiving RNA-NPs Mean Survival: Foster ES et al. J Vet Intern Med. 1988;2(2):71-4 Median Survival: Pluhar et al. Vaccine. 2010 Apr 26;28(19):3371-8
  • 29. 29 FDA-approved clinical trial of mRNA-NP vaccines in newly diagnosed adult GBM & pediatric high-grade gliomas First-in-human clinical trial approved by FDA for mRNA-NP vaccines targeting newly-diagnosed pediatric high-grade gliomas and adult GBM Phase 1 dose-escalation study in adults at UF with national Phase 2 study in pediatric HGGs through PNOC consortium PNOC-020 (Study Chair: Elias Sayour, MD, PhD) FDA IND BB-19304 Open for enrollment
  • 30. THANK YOU For additional information, contact: Duane A. Mitchell, MD, PhD President & Chair, iOncologi, Inc. The Hub at Innovation Square 747 SW 2nd Avenue Gainesville, FL 32601 dmitchell@ioncologi.com (352) 559-5100

Editor's Notes

  1. Add background slide? “The immune system plays a crucial role as the body’s primary defense against cancer. However, a significant challenge in combating cancer is the development of immunosuppression, where cancer cells manipulate and inhibit immune cells to evade detection and destruction. Immunotherapies have emerged as a revolutionary approach, leveraging the inherent power of the body's immune system to identify and fight cancerous cells. Immune checkpoint inhibitors (ICIs) are a notable example, removing the “brakes” on the immune system. Despite their success, over two-thirds of cancer patients remain resistant to ICIs. Hematopoietic stem cells (HSCs) are key contributors to the immune system's response to cancer. As multipotent stem cells, HSCs possess the remarkable ability to differentiate into various blood cell types, including white blood cells. These white blood cells are essential components of the immune system, serving as the body's primary defense mechanism against cancer. iOncologi has pioneered an advanced, immunomodulatory stem cell therapy named iMD, which overcomes the inherent resistance of brain tumors to ICIs. When combined, HSC therapy can replenish or augment the immune cell population, while ICIs can enhance the functional capacity of these cells. The increased quantity of immune cells from HSC therapy, now more active and less restrained due to ICIs, can lead to a more potent immune response against cancer cells.”