April 2013: PDS Granted IND Approval to Evaluate PDS0101 in Human Clinical Trials. The FDA has accepted PDS’s IND application to begin clinical evaluation of its first-in-class nanoparticle cancer immunotherapy PDS0101 in patients with cervical intraepithelial neoplasia. The first application of the vaccine being developed to treat cancers caused by infection with the human papillomavirus will be in the treatment of late-stage neoplasia (CIN2/3). The simple 2-component vaccine consists of nanoparticles consisting of a unique and biodegradable lipid enantiomer combined with HPV-peptide nanoparticles. In extensive preclinical toxicology studies in multiple animal models, the technology and clinical product demonstrated an excellent safety profile. PDS0101 also demonstrated excellent potency. Patient recruitment is expected to begin in Q2 2013.
December 2011: PDS completes successful pre-IND meeting with FDA. PDS had a successful face-to-face meeting with the FDA to discuss the company’s preclinical package and phase 1 human clinical trial protocol. Based on the discussions, PDS is in the process of performing the pivotal toxicology study with the final human formulation and performing GMP manufacturing in order to file the IND for PDS0101 and to initiate human clinical trials in 2012.
September 2011: Asklepios Capital, LLC the lead investor in PDS, made a third equity investment in PDS. Based on the company’s successful preclinical development of PDS0101 and demonstrated superior efficacy in treating HPV-related cancers, the funds are intended to complement NIH award funding to finalize PDS0101 preclinical studies in 2012.
May 2011: Dr. Eric Jacobson joined the PDS team as the Director of Drug Development from the University of Cincinnati where he was an Assistant Professor at The Vontz Center for Molecular Studies, Department of Endocrinology. At UC Eric’s research focused on understanding the molecular and genetic basis for disease. Prior to UC, Eric was an Assistant Professor at the Mount Sinai School of Medicine. Eric obtained his PhD in Biochemistry from Columbia University and has published widely in the fields of immunology and immunity.
September 2010: PDS Biotechnology and UNC awarded NIH grant to develop novel nanocrystal technology. The US National Cancer Institute has awarded PDS Biotechnology and The University of North Carolina at Chapel Hill a phase 1 STTR grant to apply a novel nanocrystal technology developed at UNC to the development of safer and more effective hydrophobic cancer drugs. The project is to be funded for 1 year.
September 2010: PDS invited to present at the Sachs Associates 10th Annual Biotech in Europe Investor Forum, Zurich, Switzerland. Dr. Bedu-Addo will present the company’s Versamune™ nanotechnology and preclinical drug development data at the conference on 09/29/2010. The presentation will highlight preclinical efficacy and toxicology data for the company’s HPV-cancer and melanoma immunotherapies.
March 2010: PDS Biotechnology awarded $1.3M NCI contract. PDS Biotechnology Corporation has been awarded a $1.3M phase 2 SBIR contract by the National Cancer Institute division of the US National Institutes of Health. The award is to complete studies required to file an investigational new drug application (IND) with the FDA for the company’s lead drug to treat human papillomavirus related cancers such as cervical cancer and head and neck cancer. Human clinical trials are anticipated to begin in 2010. The phase 1 contract awarded in September 2007 focused on confirming the anti-cancer efficacy of the drug in human models of the disease.
September 2009: PDS Biotechnology has completed a GLP toxicology study in rodents and non-human primates demonstrating safety of the company’s HPV cancer therapy, Versamune™-HPV. Animals received multiple doses of the drug at doses as high as 40X the preclinical therapeutic dose with no toxic side effects observed. The pharmacokinetic and bio-distribution studies also confirm efficient uptake of the nanoparticles by the dendritic cells of the immune system. The toxicology studies were funded by a contract awarded by the National Cancer Institute (NCI). Human clinical trials are planned for 2010.
September 2009: PDS Biotechnology will present the company’s technology and products at two of the industry’s leading biotechnology conferences, BioPharm America and Bio-Europe. BioPharma America will be held in San Francisco from September 16-18, 2009 and Bio-Europe from November 2-4, 2009.
April 2009: PDS Biotechnology Scientific Advisory Board member Dr. Darron Brown receives Pharmaceutical Research and Manufacturers of America (PhRMA) award for creating the first cancer vaccine. http://www.insideindianabusiness.com/life-sciences.asp?detail=true&id=140
February 2009: PDS Biotechnology Corporation Finalizes Commercial Licensing Agreement with Merck Eprova AG to Utilize Merck Eprova’s Enantiomers of DOTAP Chloride in Immunotherapies. PDS Biotechnology has obtained an exclusive license from Merck Eprova AG to utilize Merck’s proprietary chiral lipid DOTAP Chloride in PDS Biotechnology’s Versamune™–based products. PDS Biotechnology will own the intellectual property rights to products incorporating the chiral DOTAP lipids for immunotherapeutic applications.
January 2009: Dr. Darron Brown, an expert in the fields of immunology and infectious diseases and Professor of Medicine and Infectious Diseases, Indiana University School of Medicine joined PDS Biotechnology Corporation’s Scientific Advisory Board. Mr. Ron Labrum, CEO of Fenwal, Inc. and former CEO of Cardinal Health’s Healthcare Supply Chain Services also joined the company’s board of directors.
January 2009: PDS Biotechnology completed a $2.75M funding round with a $2.0M grant from the Indiana Economic Development Corporation’s 21st Century Fund. Also included in the funding round was a $0.5M investment made by Asklepios Capital, LLC the company’s lead investor and a $0.25M investment made by the Sherrie Labrum Trust. PDS Biotechnology will relocate its Cincinnati operations to a yet to be determined location in the state of Indiana.
November 2008: PDS Biotechnology Corporation completes a second round of funding with Asklepios Capital, LLC and the Labrum Trust.
October 2008: The National Cancer Institute (NCI), a branch of the United States National Institutes of Health (NIH), awards PDS Biotechnology Corporation a grant to initiate toxicology studies of Versamune™ –HPV in rodents and monkeys geared towards an IND filing with the FDA and initiation of human clinical trials.
September 2008: Dr. Mark Einstein, M.S., M.D., Director of Clinical Research, Division of Gynecologic Oncology, Department of Obstetrics & Gynecology and Women’s Health, Albert Einstein College of Medicine, Albert Einstein Cancer Center, and Montefiore Medical Center, an internationally renowned cervical cancer researcher and clinical expert in HPV-related disease joins PDS Biotechnology's scientific advisory board.
September, 2008: The National Cancer Institute (NCI), awards PDS Biotechnology a Small Business Innovation Research (SBIR) grant to develop Versamune™ –Melanoma, a therapy for melanoma, the most aggressive form of skin cancer, based on the company's simple nanoparticle Versamune™ platform technology.
June, 2008: The Nanotechnology Characterization Laboratory (NCL) selected PDS Biotechnology as an affiliate to collaborate on the development of PDS Biotechnology's HPV cancer immunotherapy Versamune™ –HPV. The NCL is a collaboration between the NCI, the FDA and NIST aimed at accelerating promising cancer nanotechnologies through regulatory submissions to clinical development.
September, 2007: The National Cancer Institute (NCI) awards PDS Biotechnology Corporation an SBIR contract to develop a therapy for cancers related to infection with the human papilloma virus. The award was based on successful review of the company’s proprietary cationic lipid nanoparticle technology Versamune™ and drug development strategy. These cancers include cervical, anal and head and neck cancers. There are currently no FDA approved therapies for these cancers.
September, 2007: PDS Biotechnology Corporation received a notice of approval of the company’s patent claims filed May, 2005, patent #7303881. The patent covers the use of the Versamune™ technology in the development of immunotherapies to treat cancer and infectious diseases.
August, 2007: Dr. Bedu-Addo, President and CEO of PDS Biotechnology, invited to present “Potent and Targeted Lipid-based Immunotherapy for the Treatment of Cancer and Viral Diseases.” at the World Vaccine Congress, Europe. October 8-10, 2007, Palais des Congrès de Lyon, Lyon, France.
April, 2007: Dr. Bedu-Addo, President and CEO of PDS Biotechnology, invited to present “A Cationic Lipid-Based Immunotherapy Technology for Use in the Development of Cancer and Antiviral Drugs” at the World Vaccine Congress, Asia. June 4-7, 2007, Meritus Mandarin, Singapore.