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Last Post: 8/4/2020 10:15:14 AM - Followers: 17 - Board type: Free - Posts Today: 1

About Us

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.

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Induction of highly potent virus-specific killer T-cells

boost

Demonstrated high levels of antigen-specific T-cell and antibody responses following a single vaccination

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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:

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PIPELINES:
https://www.pdsbiotech.com/pipeline/infectious-disease

Overview

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


https://www.pdsbiotech.com/pipeline/oncology
 

Partnerships

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:

merck nih

Strategic Research Collaborations with:

NCI Stacked COLOR nih nih niaid
 

Leadership Team

Frank Bedu Addo PDS

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.

 

Frank Bedu Addo PDS

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.

 

Frank Bedu Addo PDS

MICHAEL KING
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.

 

Frank Bedu Addo PDS

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.

VERSAMUNE®
PLATFORM

Transformative Vaccines

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:

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Stimulate the immune system to recognize the pathogen and induce potent antibody response for near-term protection

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Induce potent killer T-cell and memory T-cell response for long-term protection

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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.

https://www.pdsbiotech.com/investors/news-center/press-releases/news-2020

 

                                                                                                  Scientific Presentations And Publications:

                                                                                                                                                     https://www.pdsbiotech.com/versamune-platform/publications

 


Gandhapudi SK, Ward M, Bush JPC, Bedu-Addo F, Conn G, Woodward JG. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL responses through novel induction of a Type I IFN response. J Immunol. 202 (12): 3524-3536.
 

Vasievich EA, Ramishetti S, Zhang Y, Huang L. 2012. Trp2 peptide vaccine adjuvanted with (R)-DOTAP inhibits tumor growth in an advanced melanoma model. Mol Pharmaceutics. 9(2): 261-268.
 

Vasievich EA, Chen W, Huang L. 2011. Enantiospecific adjuvant activity of cationic lipid DOTAP in cancer
vaccine. Cancer Immunol Immunother. 60(5): 629-638.
 

 


Chen W, Yan W, Huang L. 2008. A simple but effective cancer vaccine consisting of an antigen and a
cationic lipid. Cancer Immunol Immunother. 57(4): 517-530.
 

Yan W, Chen W, Huang L. 2007. Mechanism of adjuvant activity of
cationic liposome: phosphorylation of a MAP kinase, ERK and induction
of chemokines. Molecular Immunology 44(15): 3672-3681.
 

Vangasseri DP, Cui Z, Chen W, Hokey DA, Falo LD Jr, Huang L. 2006. Immunostimulation of dendritic cell
by cationic liposomes. Mol Membr Biol. 23(5): 385-395.
 

 


Zelphati, O., Y. Wang, S. Kitada, J. C. Reed, P. L. Felgner, and J. Corbeil. 2001. Intracellular delivery of proteins with a new lipid-mediated delivery system. J Biol Chem 276: 35103-35110.
 

Felgner, P. L., T. R. Gadek, M. Holm, R. Roman, H. W. Chan, M. Wenz, J. P. Northrop, G. M. Ringold, and M. Danielsen. 1987. Lipofection: a highly efficient, lipid-mediated DNA-transfection procedure. Proc Natl Acad Sci U S A 84: 7413-7417.
 

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.

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.

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/

 

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PDSB News: Current Report Filing (8-k) 07/31/2020 05:10:06 PM
PDSB News: PDS Biotechnology Announces Conference Call and Webcast for Second Quarter 2020 Financial Results 07/30/2020 04:05:10 PM
PDSB News: PDS Biotech Announces Preclinical Data for PDS0203, a T-Cell Activating Recombinant Protein Vaccine Against COVID-19 07/27/2020 08:30:10 AM
PDSB News: Securities Registration Statement (simplified Form) (s-3) 07/22/2020 04:16:38 PM
PDSB News: Current Report Filing (8-k) 07/14/2020 04:31:13 PM
PostSubject
#209   PDSB awesome setting. Looks like we close before l2 hunter 08/07/20 12:17:55 PM
#208   going up again 4,60 1upandaway 08/04/20 10:15:14 AM
#207   4.30 1upandaway 08/03/20 03:33:29 PM
#206   upwego 5++ coming 1upandaway 08/03/20 03:30:05 PM
#205   https://www.pdsbiotech.com/images/presentation/PDS_Biotech_Corporate_Presentatio 1upandaway 08/03/20 08:29:52 AM
#204   expect a boost to the upside.... 1upandaway 07/30/20 01:16:44 PM
#203   See what tomorrow brings starkd748 07/27/20 08:51:17 PM
#202   upwego nice reversal intraday 1upandaway 07/27/20 02:38:36 PM
#201   Maybe 5 dollars at opening bell Wesley Smith 07/27/20 09:20:39 AM
#200   O there a lot of shorts... starkd748 07/27/20 09:19:40 AM
#199   Let’s get a nice squeeze today!!!... if we silkyballer 07/27/20 09:16:39 AM
#198   My roth ira is happy lol starkd748 07/27/20 08:51:13 AM
#197   Big news!!!! silkyballer 07/27/20 08:49:36 AM
#196   Gonna be a great day today IMO Wesley Smith 07/27/20 08:39:02 AM
#195   Fantastic news out $$$$$ Wesley Smith 07/27/20 08:38:02 AM
#194   Sextuplets HTBX has the 150 million shelf offering Fress 07/24/20 02:34:03 PM
#193   next week upwego 1upandaway 07/24/20 01:27:51 PM
#192   100 milly offering not yet starkd748 07/24/20 12:59:01 PM
#191   looks like upwego 1upandaway 07/23/20 03:40:31 PM
#190   Oh baby boy silkyballer 07/23/20 11:20:22 AM
#189   Top Covid Plays: Fress 07/23/20 11:18:15 AM
#188   warming up Fress 07/23/20 10:57:54 AM
#187   From your lips to gods ears silkyballer 07/22/20 04:49:26 PM
#186   Tick Tock Tick Tick Tock Fress 07/22/20 03:23:09 PM
#185   Patiently waiting for the Kaboom.. Fress 07/22/20 01:50:37 PM
#184   Agreed silkyballer 07/22/20 09:17:48 AM
#183   Yes for me everything feels right here, I Wesley Smith 07/22/20 08:20:33 AM
#182   PDSB very strong in PM, most biotech are down... Eisholland 07/22/20 07:45:28 AM
#181   CEORoadshow Interview with Dr. Frank Bedu-Addo, President & Fress 07/21/20 09:36:27 PM
#180   PDS Biotech Collaborator Granted NIAID Award to Accelerate Fress 07/21/20 08:56:12 PM
#179   This is what will differentiate Versamune-CoV-2FC from other Fress 07/21/20 08:02:06 PM
#178   Noooope lol starkd748 07/21/20 05:47:36 PM
#177   PDSB Biotechnology and Farmacore Biotechnology announce co-development of Fress 07/21/20 05:05:14 PM
#176   "The preliminary results are expected to be concluded Fress 07/21/20 04:52:18 PM
#175   back from beach. Whats up??? no $6 zetti 07/21/20 03:30:57 PM
#174   MM signal 505 is a very good sign. Fress 07/21/20 01:53:26 PM
#173   Weeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee looks lik Fress 07/21/20 01:33:57 PM
#172   Gap filled starkd748 07/21/20 12:47:09 PM
#171   Beautiful reset. Fress 07/21/20 12:45:18 PM
#170   Not yet ... starkd748 07/21/20 11:19:59 AM
#169   Yep gap must fill no 450s or 6 starkd748 07/21/20 11:19:28 AM
#168   gapclose area 3,20-3,40 1upandaway 07/21/20 11:02:23 AM
#167   Agreed! silkyballer 07/21/20 10:22:36 AM
#166   Here we go, in an hour we are Eisholland 07/21/20 10:15:50 AM
#165   Red to green we needed that reset to Fress 07/21/20 09:53:53 AM
#164   Yess a good thing starkd748 07/21/20 09:41:32 AM
#163   looks like gapclose today... 1upandaway 07/21/20 09:40:15 AM
#162   Let’s goooooo silkyballer 07/21/20 09:27:02 AM
#161   PDSB around $5 opening and $6 test in l2 hunter 07/21/20 09:06:50 AM
#160   Opening SQUEEZE? l2 hunter 07/21/20 09:02:27 AM
PostSubject