CEO Quarterly Update
First Quarter 2013
PDS has received approval from the FDA for its Investigational New Drug (IND) application to evaluate PDS0101 for treatment of HPV-induced cancers and pre-cancer in a phase 1 human clinical trial. The first-in-class therapeutic vaccine will be the first immunotherapy of its kind. The 2-component vaccine consists of nanoparticles consisting of a unique and biodegradable lipid enantiomer combined with HPV-peptide nanoparticles. The product demonstrated an excellent safety profile in preclinical toxicology studies, and also demonstrated excellent potency. Clinical manufacturing has been completed, and PDS anticipates that phase 1 clinical studies to be performed in patients with early stage cervical intraepithelial neoplasia (CIN) will begin during the second quarter of 2013.
PDS also continues to develop its simple and effective nanoparticle pandemic influenza vaccine (PDS0102) which has demonstrated superior potency in an in-vivo preclinical model. The prophylactic vaccine is also based on the proprietary Versamune™ platform.
Mr. Tom Stuart a well-respected veteran pharmaceutical executive joined PDS’s board of directors. The web site has been updated to include Tom’s bio. PDS welcomes Tom to the board.
Fourth Quarter 2012
PDS continues to rapidly progress development of its HPV cancer immunotherapy. PDS also continues with application of the nanotechnology to the development of safer and more effective influenza vaccines.
PDS0101 – Treatment of HPV-induced cancers and pre-cancer
PDS has begun the process of evaluating potential clinical sites for the upcoming phase 1 human clinical trial in HPV-induced cancer. The company intends to select 2-3 US based sites where the clinical trial will be performed. This study will be the first test of the company’s novel cancer treatment in humans and should pave the way for application of the proprietary technology in other innovative cancer therapies.
Third Quarter 2012
PDS continues to progress development of its 2 lead cancer immunotherapies to treat HPV-induced cancers and melanoma. PDS also continues with application of the nanotechnology to the development of safer and more effective influenza vaccines.
PDS0101 – Treatment of HPV-induced cancers and pre-cancer
PDS and its selected cGMP clinical manufacturer have completed successful manufacture of the clinical product to be utilized in the upcoming clinical trial. A detailed toxicological study of the clinical product in humanized transgenic mice was also completed and showed no signs of toxicity at all tested doses. This is in agreement with toxicology studies performed in non-human primates and rats. During Q3 PDS also selected an experienced CRO to run the phase 1 human clinical trial. The data will be presented at a conference to be announced in the near future.
Second Quarter 2012
PDS continues to progress development of its 2 lead cancer immunotherapies to treat HPV-induced cancers and melanoma. PDS also initiated application of the Versamune™ technology to the development of a universal pandemic influenza vaccine.
PDS0101 – Treatment of HPV-induced cancers and pre-cancer
PDS and its selected cGMP clinical manufacturer have performed successful scale up and manufacture of the cGMP Versamune™ product at clinical scale. Successful completion of the “in-life” portion of the company’s pivotal toxicology study in humanized transgenic animals occurred in June with no safety concerns observed. A detailed toxicological analysis is in progress, and the data will be presented at a conference to be announced in the near future.
PDS0103 – Protection against Pandemic Influenza
PDS generated initial exciting data demonstrating significant superiority of the protective efficacy of an existing influenza vaccine at much lower doses when combined with Versamune™ prior to vaccination. The enhanced effect was seen with all virus strains contained in the vaccine. The study constitutes an initial demonstration of the nanotechnology’s compatibility with viral preventative vaccines, and provides the first steps towards the development of safer, cheaper and more potent preventative vaccines.
Licensing and Partnerships
On June 28 2012, PDS granted Merck KGaA, Darmstadt, Germany a license to utilize PDS’s proprietary Versamune™ technology in two therapeutic cancer vaccines currently being developed by Merck (see July 9, 2012 Press Release).
First Quarter 2012
PDS continues to make great strides with developing its two lead immunotherapies. PDS just concluded another exciting quarter in the company’s growth and progress.
PDS0101 – HPV-induced cancers and pre-cancer
PDS selected a manufacturer to synthesize the HPV peptides to be included in the final clinical formulation under FDA current Good Manufacturing Processes (cGMP) guidelines. PDS also selected a cGMP-capable manufacturer to manufacture and fill the final clinical product to be used in the final pivotal toxicology study and in the up-coming phase I human clinical trial. PDS initiated transfer of all production methods to the manufacturing facility.
PDS0102 – Melanoma
PDS continues to progress preclinical development of its melanoma vaccine. Results of an immunological study to understand key parameters influencing vaccine potency were performed in the laboratory of Prof. Leaf Huang at UNC Chapel Hill. The very enlightening and promising results were published in the 2012 Vol. 9 (2) issue of Molecular Pharmaceutics.
Conferences and Presentations
Dr. Bedu-Addo has accepted an invitation to present on PDS’s Versamune™ nanotechnology and products at the upcoming 2012 Bio International Convention and Business Forum being held this year in Boston from June 18-21.