PDS Biotech was established after the discovery that certain positively charged cationic lipids are able to induce a powerful activation of the immune system. The PDS Biotech scientific team observed that these cationic lipids induce high levels of protective neutralizing antibodies when combined with certain disease-related proteins called antigens. When administered with disease-specific antigens, these lipids efficiently induced the body to produce targeted killer T-cells. This was a major accomplishment that had previously been a significant hurdle impeding the effectiveness of immunotherapy technologies to effectively harness the body’s immune system to fight cancer. Additionally, the role of both antibodies and killer T-cells in the management of pathogen-induced diseases is well studied. The Versamune® platform enables the development of vaccines capable of activating both the defensive and curative arms of the immune system to better prevent and potentially treat these deadly infectious diseases.
PDS Biotech’s team has studied all the underlying biologic mechanisms related to how specific cationic lipids interact in the body and have used that proprietary knowledge to engineer Versamune® to optimize its effectiveness.
PDS Biotech is developing multiple therapies based on the Versamune® platform, which has been designed to activate an adaptive immune response to specific disease targets. When combined with disease-specific proteins, Versamune® induces high levels of protective neutralizing antibodies to create powerful vaccines to defend against infectious diseases. When paired with an disease-specific antigen the body’s immune system produces antigen-specific T-cells to fight and kill the disease.
PDS Biotech has partnered with some of the leading institutions in cancer research and vaccine development to advance clinical testing of PDS Biotech products in multiple therapeutic areas. PDS Biotech clinical strategy in advanced cancer is to focus on efficiency and risk mitigation to proof of concept 16 Versamune®-based immunotherapies are being developed as combination therapies to exploit the demonstrated synergies between Versamune® and other anti-cancer agents
Checkpoint inhibitors have shown confirmed clinical efficacy and have demonstrated clinical benefit in late stage cancer ? Checkpoint inhibitors block a key immunological defense mechanism for cancer cells, and are reported to work primarily in patients whose immune systems are already generating tumorattacking CD8+ killer T-cells pre-treatment • Using various tumor-specific proteins (antigens), Versamune® has demonstrated the unique ability to generate large and superior numbers of CD8+ killer T-cells that effectively recognize and kill antigenexpressing cancer cells in pre-clinical and human clinical studies
Versamune® is a proprietary T-cell activating platform technology designed to train the immune system to better protect and fight against disease. Versamune® delivers both a protective disease-specific antibody and powerful curative killer T-cell response with minimal side effects and is engineered for simplicity and ease of administration.
Versatile and potent T-cellactivating platform ? Clinically validated induction of active antigen-specific killer helper T-cells as well as antibodies in vivo ? Promising clinical efficacy in early trials of PDS0101 monotherapy with good safety and no dose limiting toxicities.
Versamune® design and novel immunological mechanisms of action promote a powerful disease-specific killer T-cell response
Mechanism of action associated with regression of disease in human studies (PDS0101 monotherapy)
Mechanism of action results in a lack of clinically relevant toxicities, even at the highest dose, in human studies
? Publicly listed on NASDAQ: PDSB ? ~15 employees with headquarters in Florham Park and Princeton, NJ ? 15.4M shares outstanding* insiders own 39% insititutions 10% net scientific own 8% with approximately $21.0M in cash
COVID-19 Vaccine Program
Developing Potent, Broadly Protective Vaccines Against This Pandemic Virus.
PDS Biotech is proud to respond to the continuing COVID-19 global health emergency. This page summarizes our work to advance PDS0203 and PDS0204, our vaccine candidates against the novel coronavirus. Both PDS0203 and PDS0204 stimulate a broad, potent and rapid immune response using the Versamune® platform that is simple, safe and scaleable.
COVID-19 Vaccines That Rapidly Produces Both T-Cells And Antibodies Against SARS-CoV-2
Versamune®-based vaccines are designed to train the immune system to better protect against infectious diseases. Versamune® delivers both a protective antibody and powerful T-cell response with minimal side effects. Versamune® also induces long-term memory T-cell responses. T-cells are an essential component of our immune system with the unique ability to attack foreign agents, including viruses. The advantage of inducing virus-specific T-cell responses in addition to neutralizing antibodies is that it provides broader protection against severe illness caused by viruses like SARS-CoV-2, the virus responsible for COVID-19. The advantage of inducing virus-recognizing memory T-cell responses is that this protection may be retained for several years.
PDS Biotech has demonstrated that our Versamune® platform safely produces a robust T-cell response against viral targets in humans. Our goal for both PDS0203 and PDS0204 – each of which contains a different antigen of SARS-CoV-2 - is to demonstrate rapid immune responses after a single vaccine dose that is well tolerated.
Induction of highly potent virus-specific killer T-cells
Demonstrated high levels of antigen-specific T-cell and antibody responses following a single vaccination
Technology composed of a single synthetic, cost-effective lipid poised for rapid commercial scale-up
PDS Biotech is working urgently to develop an effective vaccine for global deployment. This work is currently in preclinical development.
Collaborating to address an urgent global health crisis
PDS Biotech is working with a global coalition of partners to rapidly advance our COVID programs:
PDS Biotech’s pipeline combines Versamune® technology with disease-specific antigens in both the development of cancer immunotherapies and infectious disease vaccines.
Oncology Infectious Disease
PDS Biotech aims to advance and expand its proprietary pipeline programs independently or in collaboration with renowned research institutions and pharmaceutical companies.
Key commercial partners:
Strategic Research Collaborations with:
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FRANK BEDU-ADDO, PH.D.
CHIEF EXECUTIVE OFFICER, DIRECTOR
Dr. Bedu-Addo has served as a director, president and CEO of PDS Biotech since its inception in 2005. Dr. Bedu-Addo is a veteran biotech executive with experience successfully starting and growing biotechnology organizations. He has been responsible for the development and implementation of both operational and drug development strategies, supervising and managing both large organizations and emerging biotechnology companies. Dr. Bedu-Addo was a founding and senior executive at KBI BioPharma, Inc. As Vice President of Drug Development, he oversaw all business and drug development operations.
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GREGORY CONN, PH.D.
CHIEF SCIENTIFIC OFFICER
Dr. Conn has more than 35 years of drug-development expertise, including development of antiviral and anticancer drugs through to commercialization. He is a graduate of the Albert Einstein College of Medicine, where he obtained both his M.S. and Ph.D., discovering novel angiogenic molecules in the human brain. Dr. Conn started his pharmaceutical career at Merck, Sharpe, and Dohme, where he continued his work on novel angiogenic factors, discovering and characterizing the VEGF family of growth factors, work which led to the development and commercialization of the anti-cancer drug Avastin.
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CHIEF FINANCIAL OFFICER (INTERIM)
Mr. King joined PDS Biotech in 2014 as the Chief Financial Officer and took the company public via a reverse merger with Edge Therapeutics in March 2019. From the completion of the merger through his appointment as interim Chief Financial Officer in 2020, he served as a financial consultant to PDS Biotech. Mr. King is the former long-time Chief Business Officer and CFO of Aprecia Pharmaceuticals, a specialty pharmaceuticals company that develops branded specialty products using three-dimensional printing, a unique pharmaceutical manufacturing technology.
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LAUREN V. WOOD, M.D.
CHIEF MEDICAL OFFICER
Dr. Wood joined PDS Biotech as Chief Medical Officer in February 2019. She has overall responsibility for clinical development of the novel, immune activating Versamune® platform product pipeline targeting HPV-related pre-cancer and advanced cancers as well as a broad spectrum of solid tumors. With 30 years of extensive clinical research experience at the National Institutes of Health, Dr. Wood most recently was the Clinical Director of the Vaccine Branch, Center for Cancer Research, National Cancer Institute. While there she oversaw the translational development of immune-based therapies for both cancer and HIV infection and was a co-inventor of two patented therapeutic cancer vaccine platforms targeting the TARP and HER tumor antigens.
Vaccines are essential to protect against pathogens such as viruses. Effective vaccination has been instrumental in limiting the incidence of several debilitating diseases such as measles, polio and rubella. The development of more effective vaccines is critical in the fight against pathogens that cause certain diseases including tuberculosis, influenza and coronaviruses. Vaccines that induce virus-specific killer T-cell responses in addition to neutralizing antibodies are much more effective in providing protection against severe illness caused by such viruses. An ideal vaccine can:
Stimulate the immune system to recognize the pathogen and induce potent antibody response for near-term protection
Induce potent killer T-cell and memory T-cell response for long-term protection
Provide protection safely with no clinically relevant toxicities
Effective vaccines must also be easily manufactured, highly stable and simply delivered to optimize delivery to a large number of healthy patients.
Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to eradicate HPV-positive tumors after a single dose 9 Produces > 10-fold number of highly potent (polyfunctional) killer T-cells vs. other T-cell technologies
PDS Biotechnology and Farmacore Biotechnology Announce Co-Development of PDS0204 COVID-19 Vaccine...
Brazilian government to provide initial funding... PDS Biotech retains the right of first refusal for commercialization outside of Latin America. PDS Biotech is in discussions with other governmental and non-governmental agencies regarding additional funding for a COVID-19 vaccine.
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PDS0101 is the only compound selected by Merck for evaluation in combination with KEYTRUDA® as first line cancer therapy • PDS0101 + KEYTRUDA® ? Keytruda® first immunotherapy approved as standard of care for first line treatment of cancer (recurrent or metastatic head and neck cancer) ? PDS0101 first T-cell activating immunotherapy to demonstrate both high levels of circulating CD8+ killer Tcells and therapeutic benefit as monotherapy ? Unique immuno-oncology combination addressing first-line treatment of cancer ? Validation of both efficacy and safety of PDS0101 ? Anticipated advantages of combining PDS0101 with standard of care: ? Mitigated risk ? Potential enhanced rates of recruitment ? Potential for rapid market penetration and market leadership.
|Smalley Rumfield C, Pellom ST, Morillon II YM, Schlom J, Jochems C. 2020. Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine. J. for ImmunoTherapy of Cancer 8:e000612. |
Multiple layers of technology and product protection for Versamune®- related products through mid-2030s are secured • Versamune® and associated patents are owned and licensed by PDS Biotech • Patents cover methods and compositions stimulating/promoting an immune response with Versamune® technology in various forms and mechanisms through 2034 – Use of specific cationic lipids to induce an immune response – Compositions and use of any cationic lipid to activate MAP kinase – Compositions and use of R-DOTAP to induce immune response – Micellar antigen + cationic lipids compositions (US still ongoing) – Compositions of R-DOTAP with GM-CSF to reduce immune suppressive myeloid derived suppressor cells in the tumor • Five issued international patent families (including Europe and Japan) https://www.pdsbiotech.com/