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PDS Biotechnology reports positive Phase I clinical trial results in proprietary HPV-Cancer Immunotherapy
Date:5/28/2015

NORTH BRUNSWICK, N.J., May 28, 2015 /PRNewswire/ -- PDS Biotechnology Corp. announces preliminary data showing that PDS0101, a cancer immunotherapy treatment targeting HPV-16, has generated strong T-cell responses in pre-cervical cancer patients. 

Currently, pre-cervical cancer is treated by surgical removal of lesions however, PDS0101 could offer a simple and effective non-surgical alternative. Results show that it primes and activates the body's defense mechanisms (T-cells) to recognize, target, and kill precancerous and cancerous cells that display HPV viral proteins, which are responsible for over 99% of cervical cancers.  All patients who had little to no pre-treatment immune responses to HPV-16, the population most likely to progress to invasive cancer, generated robust T-cells targeting HPV.

These promising clinical results from all four patients in this ongoing trial is the first demonstration of PDS Biotechnology's proprietary synthetic immunotherapy technology, Versamune's®, application in human cancer. The results mirror its preclinical data which showed strong T-cell responses and aggressive tumor regression with low doses of the product. 

The combination of Versamune's® human efficacy and safety profile is an important step towards the development of next generation therapies to treat both early and late stage cancers. It also suggests that the Versamune®-based products will be uniquely suited for use in combination with other immuno-oncology platforms to develop powerful therapies.

Dr. Frank Bedu-Addo, PDS President and CEO, said: "We are encouraged by these positive first-in-man results that help validate the potential for a wide range of simple, safe and powerful Versamune®-based immunotherapies to generate the right type of T-cells to kill cancer cells.

"We now plan to conduct two Phase II clinical trials, in late-stage cervical intra-epithelial neoplasia (CIN) and cervical cancer, to study Versamune's® ability to reduce the amount of specific immune suppressive cells and overcome a tumor's immunosuppressive environment."

About PDS Biotechnology

PDS Biotechnology is a clinical-stage biotechnology company developing a new generation of simpler, more effective and safer cancer immunotherapies.  The company owns the proprietary Versamune® immunotherapy platform.  PDS0101 is the company's lead cancer immunotherapy in development to treat HPV-induced cancers.  PDS Biotechnology has established key partnerships to develop the company's oncology and infectious disease pipelines.  For more information on PDS biotechnology please visit www.pdsbiotech.com.

About Versamune®

Versamune® is a first-in-class synthetic technology that efficiently accesses an immunological pathway known as the MHC Class-I pathway, a key to activating effector killer T-cells called CD8+ T-cells.  Versamune® also activates the induction of important proteins called chemokines which cause the generation of robust CD8+ T-cell responses. Certain formulations of Versamune® have been demonstrated to reduce the population of immune suppressive cells, thus making the T-cells significantly more effective in their tumor killing function.   

About HPV-Caused Cancers

Human papillomavirus (HPV) plays a key role in the development of several cancers including cervical intraepithelial neoplasia (pre-cancer), cervical cancer, head and neck cancers and anal cancer, and is the most common sexually transmitted agent worldwide. Approximately 78 million Americans are believed to be infected with HPV and 420,000 Americans are diagnosed with CIN each year. Approximately 13,000 new cases of invasive cervical cancer are diagnosed each year.


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SOURCE PDS Biotechnology Corporation
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