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 Corporation (PDSB) announced preliminary results from its PDS0101 Phase 2 clinical studies at SITC 2022, highlighting 100% clinical response in locally advanced cervical cancer patients. The company reported a successful end-of-Phase 2 meeting with the FDA for VERSATILE-002, advancing to a registrational trial. Financially, PDSB experienced a net loss of $7.4 million for Q3 2022, slightly up from $7.0 million in Q3 2021, driven by increased R&D costs. The cash balance as of September 30, 2022, stood at $71.6 million, supporting ongoing clinical programs.
PDS Biotechnology Corporation (PDSB) recently presented updated data from its ongoing IMMUNOCERV Phase 2 clinical trial at the Society for Immunotherapy of Cancer (SITC 2022). The study, which explores PDS0101 combined with standard chemoradiotherapy (CRT) for advanced cervical cancer, reported that 100% of patients exhibited tumor shrinkage of over 60% at midpoint evaluations. Additionally, 89% showed no evidence of disease by day 170. The data indicates that PDS0101 effectively activates HPV16-specific T cells, suggesting a promising new treatment approach for cervical cancer.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced significant findings from two Phase 2 clinical trials of PDS0101, an immunotherapy for HPV-positive cancers, to be presented at the SITC 2022. The IMMUNOCERV trial showed a 100% 1-year overall survival rate among patients receiving PDS0101 with chemotherapy and radiation, with 87.5% achieving complete response. Additionally, a triple combination trial indicated a more than two-fold increase in HPV-specific T cells in 79% of patients. The results suggest PDS0101's potential to enhance therapeutic responses in challenging cancer cases.
PDS Biotechnology Corporation (Nasdaq: PDSB) will announce its third-quarter financial results on November 14, 2022, prior to market opening. A conference call will follow to discuss the results and provide a business update. The company focuses on developing immunotherapies targeting cancer and infectious diseases, utilizing its proprietary Versamune® and Infectimune™ technologies. The lead candidate, PDS0101, has shown promise in clinical trials for HPV-positive cancers.
PDS Biotechnology Corporation (Nasdaq: PDSB) recently hosted a Head and Neck Cancer KOL Roundtable to discuss advancements in treatment for HPV-positive cancers, focusing on PDS0101 and its combination with KEYTRUDA®. Lead Investigator Jared Weiss presented interim data from the VERSATILE-002 clinical trial, reporting an objective response rate of 41.5%, with a clinical benefit rate of 76.5% and an overall survival rate of 87.2% at nine months. The event highlighted unmet medical needs in head and neck cancer and PDS0101's potential role in treatment protocols.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced that its Chief Medical Officer, Dr. Lauren V. Wood, will speak at the 2022 International Head and Neck Cancer Conference in Sunderland, UK, on November 8-9. The conference aims to enhance patient experiences and treatment options for those affected by head and neck cancer. PDSB's lead candidate, PDS0101, is an investigational HPV-targeted immunotherapy currently in Phase 2 studies, demonstrating a 41% objective response rate in early data, compared to 19% for KEYTRUDA alone.
PDS Biotechnology Corporation (Nasdaq: PDSB) will present at the LD Micro Main Event XV on October 26, 2022, at 4:30 PM PDT in Beverly Hills, California. The company focuses on targeted immunotherapies for cancer and infectious diseases through its Versamune® and Infectimune™ technology platforms. The lead candidate, PDS0101, shows promise in reducing tumors in HPV-positive cancers. Interested parties can access the presentation via a livestream.
PDS Biotechnology Corporation (Nasdaq: PDSB) announces the acceptance of an abstract detailing preclinical studies of its oncology products, PDS0102 and PDS0103, for presentation at the AACR Special Conference on Tumor Immunology and Immunotherapy 2022 in Boston from October 21-24, 2022. The abstract highlights the use of the Versamune® platform to target cancers like acute myeloid leukemia, prostate cancer, and breast cancer. The company aims to address multiple cancers with its innovative immunotherapies.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced it will host a Head and Neck Cancer Key Opinion Leader Roundtable on October 26, 2022. The event aims to discuss the treatment of head and neck cancer, centering on PDS0101, the company’s leading product candidate that targets HPV-positive cancers. Moderated by Dr. Lauren Wood, the roundtable will feature insights from renowned oncologists. Registration is now open, and a live webcast will be available on their investor relations website.
PDS Biotechnology Corporation (PDSB) announced promising interim data from its Phase 2 trial of PDS0101-based therapy for advanced HPV-positive cancers. Notably, 66% of HPV 16-positive checkpoint inhibitor refractory patients survived at a median follow-up of 16 months, a significant improvement over the historical survival of 3-4 months. The trial, conducted at the National Cancer Institute, also highlighted a manageable safety profile, with 48% experiencing Grade 3 adverse events. The results underscore the potential of this therapy in a patient population with limited treatment options.