Movers and SHAKERS
PDS Biotechnology Corp (PDSB)
NCI-sponsored Phase 2 Study will Progress to Full Enrollment
PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.
Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.
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Moving towards full enrollment based on preliminary efficacy. Yesterday, PDS Biotechnology announced achievement of preliminary efficacy leading to progression of Phase 2 study to full enrollment. The National Cancer Institute’s (NCI) sponsored Phase 2 trial is evaluating PDS0101 in combination with two investigational immune-modulating agents bintrafusp alfa (M7824, a TGF-b / anti-PD-L1 bifunctional fusion protein) and NHS-IL12 (M9241, a DNA-targeted immunocytokine) for the treatment of advanced human papillomavirus (HPV)-associated cancers. Trial progression was decided initially based on the safety profile of the triple combination. Then on the efficacy front, the triple combination was expected to exceed (~40%) the single-agent M7824 clinical efficacy (30.5% objective response rate, ORR, published on J ImmunoTher Cancer 2020 October). As the objective response was observed in 3 out of 8 patients (37.5% ORR), the Phase 2 study will progress to full enrollment.
Phase 2 study details. The Phase 2 clinical study (NCT04287868) evaluating triple combination (M7824, M9241, and PDS0101 in a total of 40 subjects who are checkpoint inhibitor naïve and refractory patients with HPV-associated cancers. We anticipate more mature data in Q2/Q3 2021 ...
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