PDS news release20 May 2021 14:06
FLORHAM PARK, N.J., May 20, 2021 (GLOBE NEWSWIRE) -- 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 publication of abstract #2501 by
the American Society of Clinical Oncology (ASCO). The abstract summarizing
interim data from the National Cancer Institute (NCI)-led phase 2 trial has
been accepted for oral presentation at the 2021 ASCO Annual Meeting taking
place June 4-8. The presentation, scheduled for June 7, is expected to include
results from a larger sample than the 14 patients included in the abstract.
Additional data highlights from abstract #2501 include:
* An overall objective response rate of 71% (10/14) in patients with
refractory HPV16-associated cancers * 1 complete response (anal cancer)
* 9 partial responses (3 cervical cancer, 2 vulvar/vaginal cancer, 2 anal
cancer, 2 oropharyngeal cancer)
* 90% of these of these responses are ongoing after a median 5 months of
follow up (9/10)
The NCI Center for Cancer Research’s Laboratory of Tumor Immunology and
Biology (LTIB) and Genitourinary Malignancies Branch (GMB) are jointly leading
this Phase 2 trial (NCT04287868), which studies PDS0101 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. Bintrafusp alfa is being
jointly developed by Merck KGaA, Darmstadt, Germany, and GlaxoSmithKline;
NHS-IL12 is being developed by Merck KGaA, Darmstadt, Germany.
The trial is evaluating the treatment combination in both checkpoint inhibitor
naïve and refractory patients with advanced human papillomavirus
(HPV)-associated cancers that have progressed or returned after treatment.
Objective response is measured by radiographic tumor responses according to
RECIST 1.1. These reported data validate the preclinical studies published by
the NCI demonstrating that the complementary mechanisms of action of the three
immunotherapies which involve potent in-vivo HPV16-specific killer and helper
T-cell induction with effective T-cell tumor infiltration, blocking of immune
checkpoints as well as targeting of TGF-ß resulted in superior tumor
regression.
“The achievement of a 71% objective response rate in a difficult to treat
patient population continues to strengthen the evidence of our novel
Versamune(®) platform’s potential ability to induce high levels of
tumor-specific CD8+ killer T-cells that attack the cancer resulting in strong
synergy with Bintrafusp alfa and NHS-IL12, thus leading to effective tumor
regression,” commented Dr. Lauren Wood, Chief Medical Officer of PDS
Biotech. “The initial data solidifies our belief that PDS0101’s published
preclinical efficacy, when combined with these two immune-modulating agents,
demonstrates the poten