Benzinga | Jun 8, 2021 07:44AM EDT

PDS Biotech's Lead Versamune Program Achieves Overall Tumor Reduction of 67% In HPV16 Positive Cancer Patients

* PDS Biotechnology Corporation (NASDAQ:PDSB) has announced interim data from the Phase 2 trial led by the National Cancer Institute (NCI) evaluating PDS0101 (Versamune-HPV16) in combination with two investigational immune-modulating agents - bintrafusp alfa and NHS-IL12 for HPV16 positive cancers.

* Data were presented at the American Society of Clinical Oncology 2021 Annual Meeting.

* 83% (5/6) of the patients demonstrated an objective response in relapsed or refractory checkpoint inhibitor na?ve advanced cancer patients.

* The reported objective response rate with the current standard of care checkpoint inhibitor treatment is 12-24%.

* 100% (6/6) are still alive at eight months.

* 80% (4/5) of patients with an objective response still have an ongoing response at eight months. One patient had a complete response.

* In patients who have also failed checkpoint inhibitor therapy, tumor reduction was observed in 58% (7/12), with an overall objective response rate of 42% (5/12) already achieved.

* 83% (10/12) of patients are still alive at eight months.

* Also, in patients with HPV16-negative cancer, 0% (0/7) experienced tumor reduction was observed.

* 80% (4/5) of checkpoint inhibitor na?ve patients are still alive at eight months. 0% (0/2) checkpoint inhibitor refractory patients are still alive at eight months.

* Price Action: PDSB shares are up 11.3% at $10.46 during the premarket session on the last check Tuesday.