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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 Corporation (PDSB) has released preliminary data from its VERSATILE-002 Phase 2 clinical trial, showcasing PDS0101 combined with KEYTRUDA. The treatment has demonstrated a 41% response rate in patients with recurrent or metastatic HPV16-positive head and neck cancer, significantly higher than the 19% response from approved monotherapy checkpoint inhibitors. Additionally, 76.5% of patients experienced either tumor shrinkage or disease stabilization, and 89% were alive at a median follow-up of 9 months, suggesting a potential survival benefit. The combination treatment was well tolerated, with no severe adverse events reported.
PDS Biotechnology Corporation announced promising results from a Phase 2 trial evaluating the combination of PDS0101, M9241, and bintrafusp alfa for advanced HPV16-positive cancers. Notably, 77% of CPI refractory patients survived at 12 months, while 75% of CPI naïve patients survived at 17 months. Objective responses were seen in 88% of CPI naïve patients and 63% of CPI refractory patients receiving high doses of M9241. The study suggests early evidence of durable clinical responses, with manageable safety profiles. The company will discuss these findings in a conference call on June 7, 2022.
PDS Biotechnology Corporation (Nasdaq: PDSB) will host a conference call on June 7, 2022 at 8:00 AM EDT following two data presentations at the 2022 ASCO Meeting. The call will cover findings from the NCI-led Phase 2 trial of PDS0101 for advanced refractory HPV-associated cancers, and the VERSATILE-002 Phase 2 trial with Merck’s KEYTRUDA for HPV16-positive head and neck cancer. A Q&A session will follow. For access, dial 877-407-3088 (domestic) or +1 201-389-0927 (international). Details available on PDS Biotechnology's website.
PDS Biotechnology Corporation (PDSB) announced the appointment of Sanjay Zaveri as Senior Vice President of Business Development on May 18, 2022. He brings substantial experience in biotechnology and pharmaceutical partnerships. Zaveri will oversee business strategy and licensing opportunities to support the company's ongoing clinical programs like PDS0101. As part of his employment, he received stock options for 150,000 shares at an exercise price of $5.35, vesting over four years. This strategic move aims to enhance PDS Biotech's business development efforts and strengthen its pipeline in immunotherapy.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced participation in key investment conferences, including the H.C. Wainwright Global Investment Conference on May 24, 2022, and the LD Micro Invitational on June 8, 2022. Additionally, they will engage in the UBS Healthcare Virtual One-on-One Day on June 1, 2022. PDSB focuses on developing immunotherapies for various cancers and infectious diseases using its proprietary Versamune® and Infectimune™ technologies. Webcast replays will be available on their investor website following the events.
PDS Biotechnology Corporation (Nasdaq: PDSB) reported a net loss of $8.5 million, or $0.32 per share, for Q1 2022, compared to $3.0 million, or $0.14 per share, in Q1 2021. R&D expenses surged to $5.2 million, up from $1.4 million, attributed mainly to higher manufacturing and clinical costs. Despite the loss, the company ended the quarter with $58.9 million in cash, enough to fund operations into 2024. PDS Biotech plans to present preliminary data from two Phase 2 trials for its leading candidate, PDS0101, at the upcoming ASCO Annual Meeting in June.
PDS Biotechnology Corporation (Nasdaq: PDSB) will release its first quarter 2022 financial results on May 11, 2022, before market opening. Management will host a conference call at 8:00 AM EDT to discuss results and provide a business update. PDS Biotech focuses on developing molecularly targeted cancer therapies and infectious disease vaccines using its proprietary Versamune® and Infectimune™ technologies. The company aims to enhance T-cell responses to effectively target and destroy diseased cells.
PDS Biotechnology Corporation (PDSB) announced updates on two clinical trials for PDS0101, focusing on HPV-positive cancers. The first abstract, presented at ASCO 2022, details a Phase 2 trial combining PDS0101 with KEYTRUDA® for recurrent/metastatic HPV16-positive head and neck cancer, achieving preliminary efficacy milestones. The second abstract discusses a National Cancer Institute-led trial combining PDS0101 with other immune therapies in HPV-associated malignancies. Enrollment is ongoing, aiming for a total of 56 participants in the refractory arm.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced that Dr. Lauren V. Wood will chair Day 2 of the Cancer and Immunotherapy Vaccines Conference at the World Vaccine Congress in Washington, DC. The conference will feature sessions focused on precision oncology, cancer vaccines, and novel immunotherapy approaches. PDS Biotech develops immunotherapies using its proprietary Versamune® and Infectimune™ technologies, aimed at enhancing immune responses against various cancers and infectious diseases. Their pipeline includes therapies targeting HPV16-associated cancers and other solid tumors.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced on April 18, 2022, the receipt of $1.2 million from the sale of tax benefits to a profitable New Jersey corporation through the state's Technology Business Tax Certificate Transfer NOL program. This funding supports the company's ongoing Phase 2 trials for PDS0101 and upcoming human trials for PDS0103. The NOL program allows eligible NJ-based tech companies to convert tax credits into necessary funds for operational growth and development.