PDS Biotech to Release of Abstract for PDS0101 in NCI-Led Phase 2...

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PDS Biotech to Release of Abstract for PDS0101 in NCI-Led Phase 2 Clinical Study

Pharma Tech Outlook | Friday, June 04, 2021

PDS Biotech prepares to release a full abstract describing their ongoing Phase 2 clinical study for oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Meeting.

FREMONT, CA: PDS Biotechnology Corporation (PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune® T-cell activating technology, announces the publication of abstract #2501 by the American Society of Clinical Oncology (ASCO). An abstract summarizing interim finding from the NCI-led phase 2 trial has been accepted for oral presentation at the 2021 ASCO Annual Meeting, which will occur on June 4-8, 2021. It is expected that results from a larger sample will be presented at the presentation scheduled for June 7th.

The clinical trial examines treatment combinations for advanced human papillomavirus (HPV)-associated cancers in patients who have failed previous treatment. RECIST 1.1 criteria detect objective tumor response. This study confirms previous NCI findings that show that in-vivo HPV16-specific killer and helper T-cell induction and the use of immune checkpoints and TGF-β inhibitors work better in treating HPV-positive tumors.

“The achievement of a 71 percent objective response rate in a difficult to treat patient population continues to strengthen the evidence of our novel Versamune® platforms 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,” comments Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “The initial data solidifies our belief that PDS0101s published preclinical efficacy, when combined with these two immune-modulating agents, demonstrates the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV-associated cancers who have limited treatment options.”

More than 630,000 HPV-associated malignancies occur annually, including cervical, oropharyngeal, and anal cancers. HPV 16 is responsible for these cases. 15-20 percent of HPV-associated malignancies respond to PD-L1 inhibitors. The majority of patients who progress on these immunotherapies do not have any standard of care therapy

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