PDS Biotechnology announces positive results from PDS0101 Phase I trial in pre-cervical cancer patients

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."