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PDS Biotechnology Corporation reports developments in targeted cancer immunotherapies based on its Versamune platform. Company news centers on PDS0101, also called Versamune HPV, in HPV16-positive head and neck cancer, and on PDS01ADC, an IL-12 fused antibody drug conjugate and tumor-targeted immunocytokine evaluated across multiple solid tumor indications.
Recurring updates include clinical-trial data, National Cancer Institute-led study presentations, FDA and IND protocol communications, scientific publications, patent coverage for core technology, quarterly financial results, and broader corporate-program updates.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company, has announced its participation in the BTIG Virtual Biotechnology Conference. The company's President and CEO, Frank Bedu-Addo, PhD, will engage in a fireside chat on Monday, August 5, 2024, at 10:00 a.m. ET.
PDS Biotech focuses on revolutionizing how the immune system targets and eliminates cancers, as well as developing vaccines for infectious diseases. Interested parties can arrange meetings with the PDS Biotech team through their BTIG representatives. After the event, a replay of the fireside chat will be accessible in the Investor Relations section of the company's website at www.pdsbiotech.com.
PDS Biotechnology provided a data update from its VERSATILE-002 Phase 2 clinical trial in head and neck cancer as of May 17, 2024. The trial focuses on the combination of Versamune® HPV and KEYTRUDA® in HPV16-positive HNSCC patients. Median Overall Survival (mOS) remains at 30 months, consistent with previous data. Out of 53 enrolled patients, 27 remain alive, 6 withdrew consent, 2 were lost to follow-up, and 18 have died. The lower limit of the 95% confidence interval is 19.7 months, while the upper limit is not yet estimable. Full data are expected in Q3 2024. PDS Biotech plans a three-arm Phase 3 trial to further evaluate treatment efficacy.
PDS Biotech (Nasdaq: PDSB) has released its Q1 2024 financial results and business updates. Key highlights include positive data from the Phase 2 VERSATILE-002 trial for HPV16-positive head and neck cancer, showing improved survival rates with Versamune® HPV and KEYTRUDA®. The company also announced a new two-part clinical trial strategy for Versamune® in combination with PDS01ADC and pembrolizumab. Financials show a net loss of $10.6 million, up from $9.7 million in Q1 2023, mainly due to increased R&D and interest expenses. Cash reserves stand at $66.6 million.
PDS Biotech's VERSATILE-002 Phase 2 clinical trial for first-line recurrent/metastatic HPV16-positive head and neck cancer met primary study endpoints with a 30-month median overall survival, impressive response rates, and a planned Phase 3 trial in 2024. The trial evaluated the combination of Versamune® HPV + KEYTRUDA® (pembrolizumab) and showed promising results. The Company also announced a two-part registrational trial focusing on a triple combination therapy.
PDS Biotechnology (Nasdaq: PDSB) will participate in two investor conferences in May 2024. The first is the Citizens JMP Life Sciences Conference on May 13 in New York, where the company will present and hold 1:1 meetings. The second event is the A.G.P.'s Virtual Healthcare Company Showcase on May 21, featuring a fireside chat with A.G.P.’s Jim Molloy and Scott Henry.
PDS Biotech, a late-stage immunotherapy company, will announce its first quarter 2024 financial results on May 15, 2024. They will also discuss positive data from their VERSATILE-002 Phase 2 clinical trial during a Key Opinion Leader Event on May 8, 2024.
PDS Biotechnology announced details of a virtual Key Opinion Leader (KOL) event focusing on updated Phase 2 trial results and unmet needs in advanced head and neck cancer. The event will discuss the positive data from the VERSATILE-002 trial and plans for a triple combination trial. Panel participants include renowned experts in the field.
PDS Biotech appointed Stephan Toutain as Chief Operating Officer, bringing over 30 years of operational experience in the pharmaceutical industry. Mr. Toutain's expertise in drug development, commercialization, and oncology will be important as PDS Biotech advances its lead program into a pivotal clinical trial. In addition to his appointment, PDS Biotech granted Mr. Toutain a nonstatutory stock option to purchase 200,000 shares of PDS Biotech common stock as an inducement to his employment.
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