PDS Biotechnology Signs Agreement With National Cancer Institute

Clinical Co-Development of Immunotherapies to treat Prostate, Breast, and HPV-related Cancers

North Brunswick Township, NJ /PRNewswire/ - PDS Biotechnology (PDS), a clinical-stage biopharmaceutical company focused on developing a pipeline of simpler, safer and more effective cancer immunotherapies based on its novel Versamune® platform, today announced that the Company has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), an Institute of the U.S. National Institutes of Health. Under the CRADA, PDS and NCI aim to co-develop several immunotherapies through Phase II clinical trials to be initiated in 2016 and 2017, utilizing combinations of Versamune® with NCI- and PDS-sourced tumor-related proteins or their fragments recognized by the immune system (antigens) in prostate, breast, and HPV-related cancers.

The PDS-NCI CRADA collaboration is led by Jay A. Berzofsky, M.D., Ph.D., Chief of the NCI Center for Cancer Research (CCR) Vaccine Branch, Lauren V. Wood, M.D., Head of the NCI CCR Vaccine Branch Clinical Trials Team, and Masaki Terabe, Ph.D., Deputy Section Chief of the NCI CCR Vaccine Branch. The CRADA encompasses Phase II clinical development, starting in late 2016, of antigen-specific immunotherapies for multiple cancers, as well as additional preclinical studies combining the Versamune® platform with specific technologies to generate potent antigen-specific and natural killer T-cell anti-tumor immune responses.

"The Versamune® platform, based on preclinical and Phase I human clinical studies, has demonstrated the potential to overcome the most critical obstacles facing cancer vaccine technologies. Versamune® enables the design of simple subcutaneous immunotherapies that efficiently deliver tumor antigens to the patient's own immune system, while simultaneously stimulating the generation of potent tumor-killing T-cells that can overcome the tumor's immuno-suppressive environment. We are very pleased to have the opportunity to collaborate with Drs. Berzofsky, Wood, and Terabe, to extend the clinical progress that has been achieved to date with our Versamune® platform and the immunotherapy field in general" said Frank Bedu-Addo, Ph.D., PDS's President and Chief Executive Officer.

About Versamune®:
Versamune® is a clinical stage and synthetic lipid-based immunotherapy platform. Due to its unusual combination of high safety and potent killer (CD8+) T-cell induction in humans, Versamune® has demonstrated the potential to achieve a key goal of cancer immunotherapy: to effectively prevent and treat cancer in its most treatable early stages. Versamune® is unique in its demonstrated potential to activate all three critical immunotherapy mechanisms, improving the potential for effective anti-tumor effect upon simple subcutaneous injection. The Versamune® platform is now being applied to the development of multiple Phase II clinical-stage cancer products, including both early and late-stage cancer indications.

About PDS Biotechnology
PDS Biotechnology is a private biopharmaceutical company with a growing pipeline of simpler, safer, and more effective clinical-stage immunotherapies to treat various early-stage and late-stage cancers. PDS is completing its first oncology human clinical trial and expects to report these Phase I study results in the very near future. PDS is also applying the versatile Versamune® platform to the prevention of selected pandemic diseases.