PDS Biotechnology Corp (PDSB)

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PDS Biotech Announces Release of Interim Data for PDS0101 in NCI-Led Phase 2 Clinical Study in Oral Presentation at ASCO 2021...

June 08 2021 - 06:00AM
GlobeNewswire Inc.

PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced the presentation of interim data from the Phase 2 trial led by the National Cancer Institute (NCI), of the National Institutes of Health (NIH), at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting.

The Phase 2 trial (NCT04287868) studies PDS0101 (Versamune®-HPV16) in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional “trap” fusion protein targeting TGF-ß and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. PDS0101 is an immunotherapy candidate designed to treat cancers caused by infection with HPV16 (HPV16-positive cancers) by activating the immune system to produce in vivo CD8+ (killer) T-cells to target and kill tumors that are HPV16-positive. Analyses of immune responses and other immune correlates are ongoing.

Highlights from the presentation include the following:

Data from a total of 25 patients with data available as of the time of presentation submission:
Update on the data previously reported for the original fourteen (14) HPV16-positive patients who were in the subject of the abstract published on May 19th.
An additional seven (7) HPV16-negative patients (patients whose cancer was NOT caused by HPV16 infection) who were not discussed in the abstract.
An additional four (4) HPV16-positive patients who are checkpoint inhibitor refractory whose data became available after the abstract submission.
100% (25/25) of patients enrolled had failed chemotherapy treatment.
96% (24/25) of patients enrolled had failed both chemotherapy and radiation treatment.
56% (14/25) of patients enrolled had failed checkpoint inhibitor therapy (checkpoint inhibitor refractory).
Most types of HPV-related cancers (anal, cervical, head and neck, vaginal and vulvar cancers) were represented among the study subjects.

The following update was provided on the initial six (6) HPV16-positive patients who had NOT been treated with checkpoint inhibitors (checkpoint inhibitor naïve):
83% (5/6) of the patients demonstrated an objective response (tumor reduction >30%). The reported objective response rate with current standard of care checkpoint inhibitor treatment is 12-24%.
100% (6/6) are still alive at 8 months – the historic average (median) survival or life span for this patient population is 7-11 months.
80% (4/5) of patients who had an objective response still have an ongoing response at 8 months.
One (1) patient had a complete response (no evidence of disease).
No new patients had been added to this group by the time of submission.

The following information was provided on the twelve (12) HPV16-positive patients who have also failed treatment with checkpoint inhibitors after failing chemotherapy and radiation treatment (checkpoint inhibitor refractory):
Four patients had recently been added since the abstract. Tumor reduction was observed in 58% (7/12), with an overall objective response rate of 42% (5/12) already achieved; the objective response rate of the current standard of care is 5-12%
One patient in this group had achieved a complete response by the time of reporting
80% (4/5) of patients who had an objective response have an ongoing response at 8 months
83% (10/12) of patients are still alive at 8 months; historic average (median) survival or life span for this patient population is only 3-4 months

PDS0101 is designed to treat patients whose cancer is caused by infection with HPV16. Seven (7) patients had cancer that was not caused by HPV16 (HPV16-negative patients). In this group
0% (0/7) experienced tumor reduction.
80% (4/5) checkpoint inhibitor naïve patients are still alive at 8 months.
0% (0/2) checkpoint inhibitor refractory patients are still alive at 8 months.


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