BiondVax is developing a long-lasting and broadly protective influenza vaccine, designed to protect against seasonal and pandemic influenza.
Recent Highlights Include:
€20 million non-dilutive funding – June 19
The European Investment Bank (EIB) signed an agreement to support commercial scale production and Phase 3
BiondVax successfully meets Phase 2b clinical trial endpoints – July 20
M-001 showed statistically significant elevated T-cell immune responses, good safety profile and well-tolerated
Israeli government support mid-size commercial facility – March 30
Ministry of Economy granted 20% of a NIS 20m budget towards construction
$10 million secondary offering – September 18
Following the placement, BiondVax has 3 large strategic investors, each holding 5% to 20%
BiondVax's next generation flu vaccine is in late Phase 2 human clinical trials. Designed to offer multi-season protection against all seasonal and pandemic influenza, results from 5 completed trials have shown safety and immunogenicity. Learn More: www.biondvax.com.
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of drug candidates intended to transform existing treatment and prevention paradigms. Its lead Phase 3 antifungal candidate, rezafungin, will report Phase 3 data at the end of 2021. The potential peak sales opportunity for rezafungin in the US is ~$750M. In addition, the Company is developing Drug-Fc Conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform.
The research of Warwick McKibbin (Australian National University, The Brookings Institution, Centre of Excellence in Population Ageing Research) and Roshen Fernando (Australian National University, Centre of Excellence in Population Ageing Research (CEPAR))
Liste des effets secondaires du vaccin Pfizer reconnus par l'EMA. Cette liste est désormais élargie aux érythèmes multiformes et aux pertes du toucher. La totalité des effets secondaires est listée dans le document (en anglais). Elle rappelle la dangerosité du vaccin sous AMM conditionnelle.
The total installed capacity of wind generation in the United States surpassed
25 gigawatts (GW) at the end of 2008. Despite the global financial crisis, another
4.5 GW was installed in the first half of 2009. Because many states already have mandates in place for renewable energy penetration, significant growth is projected for the foreseeable future. In July 2008, the U.S. Department of Energy (DOE) published the findings of a year-long assessment of the costs, challenges, impacts and benefits of wind generation providing 20% of the electrical energy consumed in the United States by 2030 (EERE 2008). Developed through the collaborative efforts of a wide-ranging cross section of key stakeholders, that final report (referred to here as the 20% Report) takes a broad view of the electric power and wind energy industries. The 20% Report evaluates the requirements and outcomes in the areas of technology, manufacturing, transmission and integration, environmental impacts, and markets that would be necessary for reaching the 20% by 2030 target. The 20% Report states that although significant costs, challenges, and impacts
are associated with a 20% wind scenario, substantial benefits can be shown to overcome the costs. In other key findings, the report concludes that such a scenario is unlikely to be realized with a business-as-usual approach, and that a major national commitment to clean, domestic energy sources with desirable environmental attributes would be required. The growth of domestic wind generation over the past decade has sharpened the focus on two questions: Can the electrical grid accommodate very high amounts
of wind energy without jeopardizing security or degrading reliability? And, given that the nation’s current transmission infrastructure is already constraining further development of wind generation in some regions, how could significantly larger amounts of wind energy be developed? The answers to these questions could hold the keys to determining how much of a role wind generation can play in the U.S. electrical energy supply mix.
BiondVax's next generation flu vaccine is in late Phase 2 human clinical trials. Designed to offer multi-season protection against all seasonal and pandemic influenza, results from 5 completed trials have shown safety and immunogenicity. Learn More: www.biondvax.com.
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of drug candidates intended to transform existing treatment and prevention paradigms. Its lead Phase 3 antifungal candidate, rezafungin, will report Phase 3 data at the end of 2021. The potential peak sales opportunity for rezafungin in the US is ~$750M. In addition, the Company is developing Drug-Fc Conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform.
The research of Warwick McKibbin (Australian National University, The Brookings Institution, Centre of Excellence in Population Ageing Research) and Roshen Fernando (Australian National University, Centre of Excellence in Population Ageing Research (CEPAR))
Liste des effets secondaires du vaccin Pfizer reconnus par l'EMA. Cette liste est désormais élargie aux érythèmes multiformes et aux pertes du toucher. La totalité des effets secondaires est listée dans le document (en anglais). Elle rappelle la dangerosité du vaccin sous AMM conditionnelle.
The total installed capacity of wind generation in the United States surpassed
25 gigawatts (GW) at the end of 2008. Despite the global financial crisis, another
4.5 GW was installed in the first half of 2009. Because many states already have mandates in place for renewable energy penetration, significant growth is projected for the foreseeable future. In July 2008, the U.S. Department of Energy (DOE) published the findings of a year-long assessment of the costs, challenges, impacts and benefits of wind generation providing 20% of the electrical energy consumed in the United States by 2030 (EERE 2008). Developed through the collaborative efforts of a wide-ranging cross section of key stakeholders, that final report (referred to here as the 20% Report) takes a broad view of the electric power and wind energy industries. The 20% Report evaluates the requirements and outcomes in the areas of technology, manufacturing, transmission and integration, environmental impacts, and markets that would be necessary for reaching the 20% by 2030 target. The 20% Report states that although significant costs, challenges, and impacts
are associated with a 20% wind scenario, substantial benefits can be shown to overcome the costs. In other key findings, the report concludes that such a scenario is unlikely to be realized with a business-as-usual approach, and that a major national commitment to clean, domestic energy sources with desirable environmental attributes would be required. The growth of domestic wind generation over the past decade has sharpened the focus on two questions: Can the electrical grid accommodate very high amounts
of wind energy without jeopardizing security or degrading reliability? And, given that the nation’s current transmission infrastructure is already constraining further development of wind generation in some regions, how could significantly larger amounts of wind energy be developed? The answers to these questions could hold the keys to determining how much of a role wind generation can play in the U.S. electrical energy supply mix.
Virios Therapeutics is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as Fibromyalgia (“FM”). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of which can be characterized by waxing and waning symptom flare-ups with no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.
Virios Therapeutics is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as Fibromyalgia (“FM”). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of which can be characterized by waxing and waning symptom flare-ups with no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.
Virios Therapeutics is a clinical-stage biotechnology company focused on
advancing novel, dual mechanism antiviral therapies to treat conditions
associated with virally triggered or maintained immune responses, such as
Fibromyalgia (“FM”). Immune responses related to the activation of tissue
resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a
potential root cause triggering and/or sustaining chronic illnesses such as
FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of
which can be characterized by waxing and waning symptom “flair-ups” with
no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a
novel, proprietary, fixed dose combination of famciclovir and celecoxib
designed to synergistically suppress HSV-1 replication, with the end goal
of reducing virally promoted disease symptoms.
Virios Therapeutics is a clinical-stage biotechnology company focused on
advancing novel, dual mechanism antiviral therapies to treat conditions
associated with virally triggered or maintained immune responses, such as
Fibromyalgia (“FM”). Immune responses related to the activation of tissue
resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a
potential root cause triggering and/or sustaining chronic illnesses such as
FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of
which can be characterized by waxing and waning symptom “flair-ups” with
no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a
novel, proprietary, fixed dose combination of famciclovir and celecoxib
designed to synergistically suppress HSV-1 replication, with the end goal
of reducing virally promoted disease symptoms.
Virios Therapeutics Inc is a development-stage biotechnology company. It is focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response such as fibromyalgia.
The Future Landscape of Covid-19 Vaccine MarketMehdiMehdiyev4
We believe that assessing the potential market for COVID-
19 vaccines is necessary in terms of reevaluating the risk/reward ratio of certain vaccine developing companies.
In addition, an overly utopian outlook for a potential COVID-19 vaccine market may lead to
disappointment and negatively affect future vaccine developers. And this concerns us more.
Vaccines have a successful history in eliminating or significantly decreasing the incidence of dangerous diseases. Vaccines prime your immune system to recognize and combat infections. Vaccines work by teaching your body to recognize specific dangerous pathogens, so your immune system is prepared to fight off that infection.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
Soligenix is a late-stage biopharmaceutical company specializing in developing and commercializing products to treat rare diseases with unmet medical needs. The Company's primary focus is on its Specialized BioTherapeutics business segment, which is responsible for the development of HyBryte™, a novel photodynamic therapy that uses safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). The Company has successfully completed a Phase 3 study for HyBryte™ and is now negotiating a confirmatory Phase 3 pivotal study design with the US Food & Drug Administration, while also evaluating/pursuing potential HyBryte™ marketing approval ex-U.S. with the successfully completed Phase 3 study.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Virios Therapeutics is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as Fibromyalgia (“FM”). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of which can be characterized by waxing and waning symptom flare-ups with no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.
Virios Therapeutics is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as Fibromyalgia (“FM”). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of which can be characterized by waxing and waning symptom flare-ups with no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.
Virios Therapeutics is a clinical-stage biotechnology company focused on
advancing novel, dual mechanism antiviral therapies to treat conditions
associated with virally triggered or maintained immune responses, such as
Fibromyalgia (“FM”). Immune responses related to the activation of tissue
resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a
potential root cause triggering and/or sustaining chronic illnesses such as
FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of
which can be characterized by waxing and waning symptom “flair-ups” with
no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a
novel, proprietary, fixed dose combination of famciclovir and celecoxib
designed to synergistically suppress HSV-1 replication, with the end goal
of reducing virally promoted disease symptoms.
Virios Therapeutics is a clinical-stage biotechnology company focused on
advancing novel, dual mechanism antiviral therapies to treat conditions
associated with virally triggered or maintained immune responses, such as
Fibromyalgia (“FM”). Immune responses related to the activation of tissue
resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a
potential root cause triggering and/or sustaining chronic illnesses such as
FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of
which can be characterized by waxing and waning symptom “flair-ups” with
no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a
novel, proprietary, fixed dose combination of famciclovir and celecoxib
designed to synergistically suppress HSV-1 replication, with the end goal
of reducing virally promoted disease symptoms.
Virios Therapeutics Inc is a development-stage biotechnology company. It is focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response such as fibromyalgia.
The Future Landscape of Covid-19 Vaccine MarketMehdiMehdiyev4
We believe that assessing the potential market for COVID-
19 vaccines is necessary in terms of reevaluating the risk/reward ratio of certain vaccine developing companies.
In addition, an overly utopian outlook for a potential COVID-19 vaccine market may lead to
disappointment and negatively affect future vaccine developers. And this concerns us more.
Vaccines have a successful history in eliminating or significantly decreasing the incidence of dangerous diseases. Vaccines prime your immune system to recognize and combat infections. Vaccines work by teaching your body to recognize specific dangerous pathogens, so your immune system is prepared to fight off that infection.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
Soligenix is a late-stage biopharmaceutical company specializing in developing and commercializing products to treat rare diseases with unmet medical needs. The Company's primary focus is on its Specialized BioTherapeutics business segment, which is responsible for the development of HyBryte™, a novel photodynamic therapy that uses safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). The Company has successfully completed a Phase 3 study for HyBryte™ and is now negotiating a confirmatory Phase 3 pivotal study design with the US Food & Drug Administration, while also evaluating/pursuing potential HyBryte™ marketing approval ex-U.S. with the successfully completed Phase 3 study.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
2. This presentation is not a prospectus or offer of securities for subscription or sale in any jurisdiction.
All statements in this communication, other than those relating to historical facts, are "forward-looking statements" within the meaning of the United States Private
Litigation Reform Act of 1995.You can identify forward-looking statements by terms including ‘‘anticipates,’’ ‘‘believes,’’ ‘‘could,’’ ‘‘estimates,’’ ‘‘expects,’’ ‘‘intends,’’
‘‘may,’’ ‘‘plans,’’ ‘‘potential,’’ ‘‘predicts,’’ ‘‘projects,’’ ‘‘should,’’ ‘‘will,’’ ‘‘would,’’ and similar expressions intended to identify forward-looking statements. These forward-
looking statements relate to our business and financial performance and condition, as well as our plans, strategies, objectives and expectations for our business,
operations and financial performance and condition. However, these forward-looking statements are not guarantees of future performance and are subject to a number
of assumptions, involve known and unknown risks, many of which are beyond our control, uncertainties and other factors that may cause our actual results, performance
or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important
factors that could cause actual results to differ materially from our expectations include, among others: the risk that drug development involves a lengthy and expensive
process with uncertain outcome; BiondVax's ability to successfully develop and commercialize its pharmaceutical product; the length, progress and results of any clinical
trials; the introduction of competing products; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in
receiving the regulatory approvals to commercialize BiondVax's products; the difficulty in evaluating business prospects; lack of sufficient funding to finance the clinical
trials; termination of license agreement with Yeda which is the owner of certain patents, patent applications and other intellectual property, as a result of dispute that can
arise with Yeda or the failure of BiondVax to comply with financial and other terms of the license; the difficulty of predicting actions of the U.S.A FDA; the regulatory
environment and changes in the health policies and regimes in the countries in which we operate; changes in the global pharmaceutical industry; changes in customers’
budgeting priorities; European Medicines Agency and other regulatory authority approvals; natural disasters; labor disputes; rising interest rates; general market, political
or economic conditions in the countries in which we operate; pension and health insurance liabilities; volatility or crises In the financial market; arbitration, litigation and
regulatory proceedings; and war or acts of terror;
Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. You should not
unduly rely on any forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot
guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The
risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Prospectus
which was declared effective on May 11, 2015. Readers are urged to carefully review and consider the various disclosures made in the Company’s SEC reports, which are
designed to advise interested parties of the risks and factors that may affect its business, financial condition, results of operations and prospects. These forward-looking
statements speak only as of the date of this presentation, and we assume no obligation to update or revise these forward-looking statements for any reason. whether as a
result of new information, future events or otherwise, except as required by law.
SAFE HARBOR STATEMENT
One • For All : The Universal Flu Vaccine
2
3. BIONDVAX’S 2017 HIGHLIGHTS
1. http://www.biondvax.com/2017/06/biondvaxs-ceo-provides-first-half-2017-general-corporate-update/
2. http://www.biondvax.com/2017/06/european-investment-bank-eib-supports-late-stage-development-and-production-of-biondvaxs-universal-flu-vaccine-candidate-under-horizon-2020-initiative/
3. http://www.biondvax.com/2017/07/biondvax-reports-positive-phase-2b-clinical-trial-results-for-its-universal-flu-vaccine/
4. http://www.biondvax.com/2017/03/biondvax-approved-for-grant-from-israels-ministry-of-economy-and-industry-to-build-facility-for-commercial-scale-production-of-its-universal-flu-vaccine/
5. http://www.biondvax.com/2017/09/biondvax-announces-closing-of-10-million-public-offering-of-american-depositary-shares-and-exercise-of-over-allotment-option/
3
€20 million non-dilutive funding2 – June 19
The European Investment Bank (EIB) signed an agreement to support commercial scale production and Phase 3
BiondVax successfully meets Phase 2b clinical trial endpoints3 – July 20
M-001 showed statistically significant elevated T-cell immune responses, good safety profile and well-tolerated
Israeli government support mid-size commercial facility4 – March 30
Ministry of Economy granted 20% of a NIS 20m budget towards construction
$10 million secondary offering5 – September 18
Following the placement, BiondVax has 3 large strategic investors, each holding 5% to 20%
“…We now have the resources to launch our Phase 3 program
towards commercialization.” 1
5. The Flu Virus: Frequent and Unpredictable Mutations
A SEASONAL PROBLEM… A PANDEMIC THREAT
SEASONAL FLU
• Per year: 23,000 deaths1 (21,000 elderly) &
200,000 hospitalizations2 in just the US
• 8th leading cause of death3 (US), Worldwide death
toll of 250,000-500,000 annually4
• $87B economic burden5 in the US of which $56B
is in the elderly
PANDEMIC FLU
• When?… Where?... Which?… pandemic strain
• Pandemic strain: a new to Humans
• Past century: 4 major pandemics with over
100M deaths5
• The 1918 Spanish Flu cost to global GDP6 was 4.8%
or over $3T in today’s dollars
Bill Gates interviewed by Ezra Klein on VOX
“I rate the chances of a widespread epidemic in my
lifetime at well over 50%”
https://youtu.be/9AEMKudv5p0
5
1 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5933a1.htm#tab2; 2 http://www.cdc.gov/flu/about/qa/disease.htm;
3 http://www.cdc.gov/nchs/fastats/deaths.htm; 4 http://www.who.int/mediacentre/factsheets/fs211/en/
5 Molinari et. al, The annual impact of seasonal influenza in the US, Vaccine 25 (2007) 5086–5096;
6 1918 Influenza: the Mother of All Pandemics, Volume 12, Number 1—January 2006, CDC; 7 World Bank 2014:Pandemic Risk
6. CURRENT VACCINE FALLS SHORT: THE MISMATCH
1 Center for Disease Control: http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm
2 World Health Organization: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf
Seasonal Flu Vaccine Effectiveness (VE)
CDC data
1
, flu seasons 2004-2017
Why current solutions fall short…
• Past strains selection Mismatch
phenomenon
• Previous season’s vaccine will not necessarily
protect against next season’s flu strains
• 4-6 month production lag
As low as
9% VE
in elderly2
Average
40% VE in
general
population
6
42%
48%
19%
52%
49%
47%
60%
56%
41%
37%
52%
21%
10%
2016-17
2015-16
2014-15
2013-14
2012-13
2011-12
2010-11
2009-10
2008-09
2007-08
2006-07
2005-06
2004-05
7. THE ELDERLY – AT RISK AND IN NEED
• ~90% of seasonal flu related death occurs in elderly
• Seasonal vaccine effectiveness as low as 9% for elderly1
• 86% of adults 65+ have chronic conditions2
• Influenza worsens outcomes of chronic illness
• Elderly flu cost in US estimated3 at $56B per year
(hospitalization, mortality, lost earnings)
1 World Health Organization: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf
2 https://www.ncoa.org/healthy-aging/flu-you/flu-facts/
3 Molinari et. al, The annual impact of seasonal influenza in the US, Vaccine 25 (2007) 5086–5096
4 http://ije.oxfordjournals.org/content/35/2/352.short
NIH: “During the period from 1989 to 1997 the vaccination rate for
elderly persons ≥65 years of age in the US increased from 30 to 67%.
Despite this increase in coverage, mortality and hospitalization rates
continued to increase rather than decline as would be expected...”
International Journal of Epidemiology4 (Vol. 35, Issue 2, P352-353)
7
8. MEETING MILESTONES & CATALYSTS
2008
1st of two Phase
1/2 (IL)
May 2015
Nasdaq: BVXV
2010
1st of four
Phase 2 (IL, EU)
Technology developed
by Prof. Ruth Arnon
Mid 90’s
June 2007
TASE:BVXV
BiondVax
Operational
2005
EMA or EOP2M1
Phase 3 ready
2018
1 End of Phase 2 Meeting with the FDA or EMA prior to phase 3
Well known for the
development of
Solid Science, Advanced Clinical Stage, Strong IP
FDA accepts
IND
One • For All : The Universal Flu Vaccine
The Vaccine is Safe and Immunogenic
• 698 young adult to elderly have participated in clinical trials
• The vaccine was shown to be safe and immunogenic in all studies
2017
8
USA NIH Phase 2
USA CMO Phase 3 material
Mid-size manufacturing
plant construction
June 2017
€20M EIB
Successful
Phase 2b (EU)
9. THINKING OUTSIDE THE BOX
BiondVax’s M-001 Existing vaccines
Universal: Broad coverage Strain specific
Single formulation enabling
year-round vaccination
New vaccine every year
Quick, robust year-round
production (6-8 weeks)
Long (4-6 month)
production cycle
Induces cellular (CMI) and
enhances humoral (HAI priming
effect) immune response to flu
Limited vaccine
effectiveness
Target Common Regions
Nine common regions (epitopes) of flu
strains are connected to make one
recombinant protein called M-001
produced in E.coli
HemAgglutinin(HA)
NucleoProtein(NP)
Matrixprotein(M1)
The Influenza Virus
Universal Flu Vaccine
A common denominator for
Seasonal & Pandemic strains
BiondVax’s Key Advantages
One • For All : The Universal Flu Vaccine
9
10. M-001: ONE MULTI-SEASON & STRAIN FLU VACCINE
One • For All : The Universal Flu Vaccine
10
• The human immune system has two arms:
• Humoral: B-cells that produce antibodies.
• Cellular (CMI): T-cells that produce cytokines with anti-viral activities.
• Current flu vaccines mainly induce antibodies (HAI) against specific flu virus
strains (variable immunodominant regions of HA).
• However, viruses are intracellular parasites, thus mostly are out of reach of our
immune system’s antibodies. However, T-cells target viruses within host cells.
• M-001 was designed to induce T-cells that target common and conserved
regions of flu viruses and to produce anti-viral cytokines such as INF-gamma and
IL-2. Indirectly, M-001 has a T-cell priming effect that enhances B-cell (HAI)
responses to flu viruses.
• Thus, M-001’s dual mode of action potentially can offer multi-season and
multi-strain protection.
11. In the clinical trials we looked
for the intrinsic CMI M-001
immunogenicity compared to
baseline and it’s priming effect
SUCCESSFUL CLINICAL TRIALS
ResultsStatus
Total
Participants
Population (age)YearTrialPhase
M-001 was well
tolerated and a
cellular (CMI) and
humoral (priming
effect) immune
response was
observed
Completed63Younger Adults (18-49)2009BVX-0021/2
Completed60Older Adults (55-75)2010BVX-0031/2
Completed200Younger Adults (18-49)2011BVX-0042
Completed120Elderly (65+)2012BVX-0052
Completed36Older Adults (50-65)2015BVX-0062
Completed219EU Adults (18-60)2015-16BVX-007*2b
698
Ongoing collaboration with NIH180USA Adults (18-45)2016BVX-0082
In preparation7,700East EU Adults (50+)2018BVX-0103
One • For All : The Universal Flu Vaccine
M-001: Safe and Immunogenic in Young Adults to Elderly
11
* BVX-007 was conducted in collaboration with the EU’s UNISEC consortium
• No treatment-related severe adverse events
• Adverse events were mild to moderate
• All adverse events observed were transient
• Both cellular and humoral immunity were induced
12. 0
0.05
0.1
0.15
0.2
0.25
0.3
A/Brisbane/10/07
H3N2
A/California/7/09
H1N1
A/Perth/16/09
H3N2
B/Brisbane/60/08 Flumist
%Positiveofallcells
Baseline Day 42 (after M-001 x2)*
*
0
0.05
0.1
0.15
0.2
0.25
0.3
A/Brisbane/10/07
H3N2
A/California/7/09
H1N1
A/Perth/16/09
H3N2
B/Brisbane/60/08 Flumist 2011
%positivecells(Mean+SE)
M-001 twice Day 0
M-001 twice Day 42* *
* *
**
M-001: DESIGNED FOR CELL MEDIATED IMMUNITY
* P<0.05
**P<0.07
12
*
*
*
1 Jacob Atsmon et al. Priming by a novel universal influenza vaccine (Multimeric-001)—A gateway for improving immune response in the
elderly population. Vaccine 32 (2014) 5816–5823
Direct Evidence: CD8, CD4 T-cell Activated Cells Produce TH1 Cytokines (IFN-gamma, IL-2 & TNF-alpha)
BVX0051: CD8 & IFN-gamma in ElderlyBVX0051: CD4 & IFN-gamma in Elderly
“Multiple-Cytokine-
Producing Antiviral CD4
T Cells Are Functionally
Superior to Single-
Cytokine-Producing
Cells”
S Kannanganat et al, J VIROL, 2007,
81(16)8468–76
211
134
1347
663
347
0
-200
0
200
400
600
800
1000
1200
1400
high
any
low
any
high
2/3
low 2/3 high
combi
low
combi
%overplacebo
*
*
*
*
Single Double Triple
M-001: 1mg 0.5mg 1mg 0.5mg 1mg 0.5mg
UNISEC (EU): 13 fold increase in responders expressing 2 cytokines (18-60 Y)
678
380
530
474
38
-23
-200
0
200
400
600
800
1000
high INF low INF highIL2 low il2 high
tnfa
low tnfa
%overplacebo
M-001: 1mg 0.5mg 1mg 0.5mg 1mg 0.5mg
IFN-gamma IL-2 TNF-alpha
UNISEC (EU): statistically significant anti viral cytokines
* P<0.05 * P<0.05* P<0.05
13. H1N1 pandemic swine flu
M-001: DESIGNED FOR CELL MEDIATED IMMUNITY
13
0
10
20
30
40
50
60
70
TIV 2011/12 M-001 & TIV 2011/12
%Seroprotection(HAI)
*
“M-001 can provide broadened enhanced immunity
extending even to influenza strains destined to
circulate in future years.” – Vaccine 2
In 2011 we
administered M-001
to seniors 65+
(BVX005)
4 years later, 5 times
more seniors were
seroprotected from a
new epidemic strain
(A/Swiss) that didn’t
exist in 2011!
1. Jacob Atsmon et al. Priming by a novel universal influenza vaccine (Multimeric-001)—A gateway for improving immune response in the
elderly population. Vaccine 32 (2014) 5816–5823
2. Lowell GH et al. Back to the future: Immunization with M-001 prior to trivalent influenza vaccine in 2011/12 enhanced protective immune
responses against 2014/15 epidemic strain. Vaccine (2017)
Indirect Evidence: Extending T-Cell Priming Effect for Enhanced HAI Responses to Current Flu Vaccines
BVX0051: 2012, age 65+ YO
BVX003: 2009, age 55-75 YO
0
10
20
30
40
50
60
70
A/California/7/09 A/Perth/16/09 B/Brisbane/60/08
%Seroconversion
TIV Twice M-001 + TIV
*
0
10
20
30
40
50
60
70
80
A/Brisbane/59/07 A/Brisbane/10/07 B/Brisbane/60/08
%seroconversion
TIV Twice M-001 + TIV
* P<0.05
14. PIVOTAL CLINICAL EFFICACY PHASE 3 DESIGN
14
• Sample size: ~7,700 participants with flexible enrollment (TBD)
• Population: 50+ years old; stratification to <65> years old (TBD)
• Endpoint: Clinical efficacy by reduction of illness rate and severity
• Phase 3 ready: First cohort enrollment expected autumn 2018
Proposed Trial Design Season 1 Season 2 Season 3 (optional)
Day 1 Day 21 Day 180 Follow up Follow up
Experimental 1mg M-001 1mg M-001 Safety, PCR
and culture on
any ILI
(flu season)
PCR and culture
on any ILI
(flu season)
PCR and culture on
any ILI
(flu season)Control Placebo Placebo
Opportunity: Financing and Phase 2 Trial Results Leads to Clinical Efficacy Phase 3
One • For All : The Universal Flu Vaccine
Study title: A multicenter,
randomized, double-blind,
placebo-controlled pivotal
phase 3 trial to assess the
safety and clinical efficacy of
a M-001 influenza vaccine
administered intramuscularly
twice in old adults and
elderly (≥50 YO)
15. PRODUCTS NEED PRODUCTION
15
• From pilot GMP to mid-size GMP manufacturing facility (Israel)*
• Funding: EIB, BiondVax, and Israel’s Ministry of Economy & Industry
• Capacity: up to 20 million single-doses or 40 million doses (bulk) per year
• Year-round Production & Stockpile per market demand
Goal: Fully Integrated Pharma Operating Under International GMP Standards
* BiondVax is in collaboration with a US-based CMO for upscaling and optimization
16. BIONDVAX: FIRST-IN-CLASS, BEST-IN-CLASS
One • For All : The Universal Flu Vaccine
16
Player Technology Strength
Phase
Progress
ReportedPre-
clinical
I II
Synthetic protein
B- & T-cell peptides
(HA, M1, NP)
• Broad coverage
• Large # of human clinical trials
• Young to elderly
Q3-2017: Statistically significant
European Ph2b trial. UNISEC
consortium. Commencing trial in
USA under NIAID/NIH
4 T-cell peptides adjuvanted
formulation
• Small challenge trial
2015 Announced collaboration
with NIAID/NIH & Europe.
UNISEC consortium. 2016
Created Imutex with hVIVO
Adenovirus vector expressing
Influenza A conserved NP and M1
proteins
• T-cell boost when administered
with TIV
Preparing for Ph2 in 2000
participants. Oxford University
spinoff, raised £10m in 2016.
Broad seasonal and pandemic
candidate. T-cell booster
• Intranasal, replication deficient
adenovirus
Formerly ITS, Vaxin. Phase 2
expected start Q3-2017. Merged
PharmaAthene, listed on
NASDAQ
DNA constructs encoding HA
proteins
• Versatile technology of mix and
match
Q3-2012 Phase 1
Single replication virus, M2SR
Broadening immunogenicity to
flu sub type H3N2
• Immunogenic in mice
Q3-2016 Phase I, H3N2
Raised $27m, including $5.5m
Aug 2017
Stem-only immunogens based on
rational design
• Innovative approach,
heterosubtypic protection in mice,
ferrets, primates
Q3-2015
Results in animals
Academic Labs
N=698
N=373
N=150
N=60
N=49
N=96
17. SUMMARY FINANCIAL DATA
Financial Data Highlights
• Successful IPO on Nasdaq in May 2015, $10M gross proceeds
• €20M EIB non-dilutive funding agreement1 signed June 2017
• Secondary offering Sept 2017, $10M gross proceeds
• Lean structure with 15 employees
• 6.5M outstanding ADS (8.8M fully diluted)2
• IFRS; calendar year basis
Balance Sheet Highlights
• >$22M cash on hand, no debt ~$30M total investment to date
• Current burn is ~$250K/month
• Ongoing clinical studies sponsored by 3rd parties
• $4.8M royalty-based liabilities from OCS grants (Office of the Israeli
Chief Scientist grants, off balance sheet)
BVXV
BVXVW
American Depository Shares ticker:
17
1 European Investment Bank (EIB) €20M support for M-001 Phase 3 trials and commercial production also includes:
• Zero-percent fixed interest loan for five years after each of the 3 drawdowns
• Variable remuneration based on royalties of net sales
• Milestone based drawdowns. Ultimate milestone includes regulatory authorization to launch Phase 3 trial
2 1 ADS = 40 ordinary shares
BVXV
Ordinary Shares ticker:
Intent to voluntarily delist from
TASE announced 31 August 2017
18. FLU VACCINES – A LARGE AND GROWING MARKET
Global Flu Vaccine Sales - 2015
$1,435M6
$410M5
$290M8
$652M7
Flu Vaccine Market
Seasonal Flu
o Worldwide: $4B global market in 20151;
expected to grow to $5.3B2 by 2021
o US: $1.4B in 2012 growing to $2.6B by 20222
o ~140M doses in just the US2
o Forecasted CAGR of 5.7%2
Pandemic Flu
o Swine Flu (A/H1N1) 2009 + first half of 2010
sales: ~$6.4B worldwide by Novartis, GSK and
Sanofi (on top of seasonal flu vaccine sales)3
“…part of the national strategy for pandemic
influenza, the United States’ plan is to stockpile enough
pre-pandemic influenza vaccines to cover 20 million in
the critical workforce.”4
“The United States has spent approximately $1 billion
in these [H5N1 flu vaccine stockpile] efforts to date.”4
2014: GSK bought Novartis’
vaccine unit except the Flu
2014: CSL bought Novartis’
Flu vaccine unit
2015: Rebrands to Seqirus
Others
2014: Pfizer bought
Baxter’s Flu vaccine unit
18
(1) http://www.cnbc.com/2015/10/19/the-16-billion-business-of-flu.html (2) Datamonitor report: DMKC0107117, Publication Date: 18/11/2013 (3) http://www.reports-research.com/news/datamonitor-vaccine-market-overview-
2010.html [Accessed 20 Nov 2016] (4) http://www.who.int/immunization/sage/meetings/2013/november/SAGE_WG_H5vaccine_background_paper_16Oct2013_v4.pdf (5) GSK, http://us.gsk.com/en-us/about-us/what-we-
do/vaccines/ (6) Sanofi, http://en.sanofi.com/Images/40570_20160209_Results-2015_presentation.pdf, slide 11 [At 31 Dec 2015 exchange rate of 1.08573] (7) CSL/Seqirus, http://annualreport.csl.com.au/year-in-review/seqirus.htm
(8) FiercePharma, http://www.fiercepharma.com/pharma/astrazeneca-s-flumist-shunned-by-cdc-group-resulting-80-million-inventory-hit [5,6,7,8 Accessed 25 January 2017]
Sanofi
36%
Seqirus / CSL
(Novartis)
16%
GSK
10%
AZ 7%
Others
31%
19. MANAGEMENT
One • For All : The Universal Flu Vaccine
Ron Babecoff
DMV, MEI
Tamar Ben-
Yedidia
PhD
Uri Ben-Or
CPA, MBA
Shimon Hassin
PhD
Joshua
Phillipson
Hon. BSc
Kenny Green
Msc, Mres
Founder,
President & CEO
CSO CFO COO BD Manager Investor Relations
•Degree from University of
Liège (ULG)
•Master in
Entrepreneurship &
Innovation (ISEMI,
Swinburne)
•Omrix Biopharmaceuticals
Ltd (Marketing Manager)
•Dexcel Pharma (Regional
Export Manager)
• Co-inventor of the
universal flu vaccine
• Degree from Weizmann
Institute of Science
• Biotechnology General
Ltd.
• Degree from College of
Administration
• Glycominds Ltd. (VP
Finance)
• Menorah Capital Markets
(Comptroller)
• Degree from University of
Maryland Biotechnology
Institute
• Kadimastem (CEO)
• InSight
Biopharmaceuticals (Head
of Bioprocessing)
• Hon. BSc. from University
of Toronto
• Accenture (Business
Management Consultant)
• BioData Ltd. (Marketing
Manager)
• Masters in Management
Degree from Cambridge
University & Master of
Research from University
of London
• IR for leading public
Israeli companies
including Elbit Systems
and Tower
Semiconductor
19
20. One • For All : The Universal Flu Vaccine
BOARD OF DIRECTORS
Board
Biodar (CEO), Rodar (Founder), Israel Biotech Organization (Chairman,
Steering committee)
Prof. Avner Rotman, PhD
Chairman of the Board
Rosen Partners LLC (Founder), CompreMedx Chairman), Kuala Healthcare
(CEO & President), Fusion Telecommunications (Director)
Mr. Jack Rosen
Director
ID Biomedical (CSO), Intellivax (Founder), Walter Reed General Hospital
(Consultant)
Dr. George Lowell, MD
Director
Omrix Pharmaceuticals Ltd (Marketing Manager), Dexcel Pharma
Technologies Ltd. (Formerly Dexxon, Regional Export Manager))
Ron Babecoff, DMV, MEI
Founder, President and CEO
Credit Suisse First Boston (Investment Banking), Private equity and venture
capital funds (Founder)
Mr. Isaac Devash, MBA
Director
Linkury Technology International Group (CFO), Union Bank, Spectronix,
Biomedix incubator, ADO group, Arko holdings, Algomizer (Director)
Mrs. Michal Marom Brikman, CPA
Director
Mor Langermann (Co-CEO), Medical Compression Systems Ltd (CFO),
Excellence Gemel & Pension Funds (External Director)
Mr. Ori Mor
Director
BioSight Ltd (CEO, Director), SHL Telemedicine (Director), Cellect
Biotechnology (Director)
Dr. Ruth Ben Yakar, PhD
Director
20
21. One • For All : The Universal Flu Vaccine
21
Expiration
Date
ADS
Equivalent
Exercise
price
NIS ($)
%
ADS
Equivalent
Shares
Outstanding26 Sept 2017
ADS-Shares 1:40 ratio
74.02%6,535,490261,419,599Ordinary shares
Employees
Variable
$ 7.20
NIS 0.70
($ 0.18)
3.49%308,48812,339,503Options
Oct 29, 2017$ 15.60
NIS 1.50
($ 0.39)
1.78%157,5506,302,000Options (Series 5)
May 5, 2020$ 6.2519.97%1,762,89770,515,880ADS Warrants
May 11, 2020$ 6.250.74%65,4252,617,000
Warrants issued to
underwriters
100.00%8,829,850353,193,982
Fully Diluted Shares
Outstanding
CAP TABLE
22. IP: COMPREHENSIVE AND EXPANDING COVERAGE
Updated: July 2017One • For All : The Universal Flu Vaccine
22 22
ExpiryStatus
Priority &
Assignee
Subject Matter
International
Publication
Title
Nov 2019
(Aug 2020
for US)
Granted: USA, Israel, Australia, Korea, Mexico, New Zealand,
Canada, Hong Kong, Belgium, France, Germany, Italy,
Netherlands, Spain, Switzerland, UK
11/30/1998
Yeda R&D
licensed to
BiondVax
Vaccine comprising
different epitopes
of the virus
WO 00/032228
Peptide-Based Vaccine for
Influenza
Dec 2026
(Jan 2027
for US)
Granted: USA, Australia, Austria, Belgium, Canada, Denmark,
France, Germany, Greece, Ireland, Israel, Italy, Luxembourg,
Netherlands, Portugal, Sweden, Spain, Switzerland, UK
12/6/2005
Yeda R&D
licensed to
BiondVax
Wide–range
vaccines – broad
strain and
extended
protection
WO 2007/066334
Improved Influenza
Vaccine
Aug 2028
(Aug 2031
for US)
Granted: USA, Mexico, Russia, Australia, China, Hong Kong, Japan,
Austria, Belgium, Croatia, Czech Republic, Denmark, Finland,
France, Germany, Hungary, Ireland, Italy, Luxembourg,
Netherlands, Poland, Portugal, Romania, Spain, Sweden,
Switzerland, Turkey, UK, Korea, Israel
Filed: Brazil
Allowed: Canada
Under Examination: India
8/2/2007
BiondVax
Vaccines
comprising multiple
copies of several
epitopes – current
product
WO 2009/016639
Multimeric Multi-Epitope
Influenza Vaccines
Feb 2031
Granted: USA, Australia
Under Examination: Canada
BiondVax
Use of Multimeric
as a primer to
conventional
vaccines
WO 2012/114323
Multimeric Multi-Epitope
Polypeptides in improved
Seasonal and Pandemic
Influenza Vaccines
April 2035
Filed: Australia, Canada, Europe, India, China, Hong Kong, Japan,
Israel, USA
4/3/2014
BiondVax
Production &
formulation
WO 2015/151103
Vaccine Compositions of
Multimeric Multi-epitope
Influenza Polypeptides
and their Production
23. THANK YOU!
CONTACT INFORMATION:
JOSHUA PHILLIPSON
j.phillipson@biondvax.com
+972-8-930-2529
www.biondvax.com
A game changer
for the world
healthcare system