PDS Biotech Announces Successful End-of-Phase 2 Meeting With the FDA and Preparation for the Registrational Trial -biotech.vision

PDS Biotech Announces Successful End-of-Phase 2 Meeting With the FDA and Preparation for the Registrational Trial

PDS Biotechnology Corporation, a clinical-stage immunotherapy company creating an expanding pipeline of targeted immunotherapies for cancer and infectious diseases, declared today that PDS0101 in combination with Merck’s anti-PD-1 medication, KEYTRUDA®, for the treatment of unresectable, recurrent/metastatic head and neck squamous cell carcinoma that is positive for human papillomavirus type 16 had successfully completed an End-of-Phase 2 meeting with the u.s.

We are very pleased with the guidance received from the FDA on key elements of the clinical program that will support the submission of a Biologics License Application for our lead asset PDS0101. The interim safety and efficacy data we presented to the FDA has allowed us to move into a registrational trial ahead of our projected schedule. This, along with the recent capital raise, allows us to efficiently advance our clinical programs.”

Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech

The FDA gave PDS0101 and KEYTRUDA® together a Fast Track designation earlier this year to treat HNSCC which is HPV16-positive. The FDA’s Fast Track designation program is intended to speed up the evaluation of drug candidate applications that have the potential to treat critical or life-threatening illnesses while also assisting in their development. With the aim of advancing potential new therapies through the process more quickly, treatments with this classification are given the chance to meet and interact with the FDA more frequently during the whole drug development and review process.

PDS0101 is a potentially game-changing therapeutic strategy for those with HPV16-positive HNSCC, continued Dr. Frank Bedu-Addo. We are dedicated to providing doctors and patients with a potentially safer and more effective treatment option for this fatal and crippling condition.

About PDS Biotechnology
PDS Biotech is an immunotherapy firm in the clinical stages of development. Based on our unique Versamune® and InfectimuneTM T cell-activating technology platforms, we are creating a growing portfolio of tailored immunotherapies for infectious and cancerous diseases. Our targeted Versamune®-based candidates have the potential to address the drawbacks of conventional immunotherapy by producing significant numbers of high-quality, highly effective, polyfunctional CD4+ helper and CD8+ killer T cells that are targeted specifically against tumors. So far, in numerous Phase 2 clinical trials, our main Versamune® clinical candidate, PDS0101, has shown the capacity to lower tumors and stabilize disease when combined with licensed and investigational treatments in patients with a wide range of HPV16-associated malignancies. In pre-clinical investigations conducted to date, our InfectimuneTM-based vaccines have also shown the ability to stimulate significant T cell responses, including long-lasting memory T cell responses, in addition to robust and long-lasting neutralizing antibody responses.

About PDS0101
PDS Biotech’s leading candidate, PDS0101, combines the Versamune® platform’s usefulness with targeted antigens in tumors that express HPV. PDS Biotech is evaluating the combination of PDS0101 and KEYTRUDA® in a Phase 2 study as a first-line treatment for recurrent or metastatic head and neck cancer as well as a second-line treatment for patients who have failed prior checkpoint inhibitor therapy. Merck & Co. and the study’s researchers are working together to carry it through. In collaboration with the National Cancer Institute, a Phase 2 clinical investigation is also being carried out in the second-and third-line administration of several advanced HPV-associated malignancies (NCI). Together with The University of Texas, MD Anderson Cancer Center, a third Phase 2 clinical trial is being conducted in the first management of locally advanced cervical cancer. The Mayo Clinic is currently conducting a final Phase 2 clinical trial of PDS0101 monotherapy as first-line therapy for patients with newly diagnosed HPV16+ head and neck cancer.

PDS0101, an investigational T cell-activating immunotherapy that targets HPV16 and uses PDS Biotech’s exclusive Versamune® technology in conjunction with Merck’s anti-PD-1 treatment, KEYTRUDA®, is being tested in VERSATILE-002, a single-arm Phase 2 trial. The combination was given Fast Track status by the Food and Drug Administration in June 2022 and is currently being tested in CPI-naive and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC).

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