On September 21, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported that checkpoint inhibitor (CPI) refractory patients have been selected as the optimal treatment group in the ongoing development of the PDS0101-based triple combination therapy in advanced HPV-positive cancers (Press release, PDS Biotechnology, SEP 21, 2022, View Source [SID1234621304]). After consulting with PDS Biotech, the study, conducted at the Center for Cancer Research (CCR) at the National Cancer Institute (NCI), one of the Institutes of the National Institutes of Health, has been closed to further enrollment given that the CPI refractory arm has been fully recruited. PDS Biotech and the NCI CCR plan to meet with the U.S. Food and Drug Administration (FDA) in the coming months to discuss the registrational path forward for the PDS0101-based triple combination therapy as a potential third-line treatment for CPI refractory, HPV-positive cancers.
The NCI-led Phase 2 clinical trial (NCT04287868) is investigating PDS0101 in combination with two investigational immune-modulating agents – M9241, a tumor-targeting IL-12 (immunocytokine), and bintrafusp alfa, a bifunctional checkpoint inhibitor (PD-L1/ TGF-β) – in recurrent or metastatic HPV-positive cancers in patients who have failed at least two standard of care therapies including CPI treatment. Both M9241 and bintrafusp alfa are owned by Merck KGaA. Data from this study, as presented at ASCO (Free ASCO Whitepaper) 2022, demonstrated that the triple combination therapy resulted in a 77% survival at a median of 12-months of follow-up in CPI refractory patients. Historical median survival rates for CPI refractory patients are 3-4 months.1 The triple combination therapy also appeared to be safe and well-tolerated with Grade 3 (43%) and Grade 4 (7%) treatment-related adverse events (AEs) reported.
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"The data generated in the CPI refractory arm of the Phase 2 trial investigating the PDS0101-based triple combination in advanced HPV-positive cancers seems compelling and potentially provides a foundation for advancing this program into late-stage clinical development," stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "For patients with CPI refractory HPV-associated disease, there is no clear effective standard of care therapy despite the severity of the disease. We intend to focus on the development of the triple combination therapy specifically for this patient group given the extreme unmet need coupled with the signals of efficacy observed in the CPI refractory Phase 2 trial arm. We believe this represents a significant value-building opportunity for PDS Biotech and our shareholders."
"The PDS Biotech team looks forward to our continued partnership with the NCI as we prepare to discuss our results in the CPI refractory population with the FDA to determine the most expeditious path forward," said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "Accordingly, in collaboration with the NCI, PDS Biotech has decided to halt enrollment of the CPI naïve patient arm to allow both parties to direct resources on progressing the trial in CPI refractory patients."