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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 (Nasdaq: PDSB) announced significant preclinical results for its investigational universal flu vaccine, PDS0202, which neutralized multiple influenza strains. In studies, animals vaccinated with PDS0202 showed significantly higher antibody levels against H1 and H3 strains and exhibited 100% survival against the H1N1 pandemic strain, unlike those with lower survival rates. The combination of Infectimune™ and COBRA antigens allowed for effective protection using 25-fold lower doses, indicating potential for a broad-spectrum influenza vaccine.
PDS Biotechnology Corporation (Nasdaq: PDSB) has appointed Spencer Brown as its new Senior Vice President and General Counsel. Brown brings extensive experience from top biotech and pharmaceutical companies, enhancing PDS Biotech's legal and compliance framework. As part of his inducement package, he received stock options for 150,000 shares at an exercise price of $4.22, which will vest over four years. This leadership change aims to support PDS Biotech’s growth in developing cancer immunotherapies and infectious disease vaccines using its proprietary platforms.
PDS Biotech announced that the FDA has granted Fast Track designation for PDS0101 in combination with KEYTRUDA® for treating recurrent or metastatic HPV16-positive head and neck cancer. This designation aims to expedite the development and review of the therapy, which shows potential in addressing a significant medical need. The ongoing Phase 2 VERSATILE-002 trial evaluates the effectiveness of this combination treatment. PDS0101 leverages the Versamune® platform and aims to improve outcomes for patients with limited treatment options.
PDS Biotechnology Corporation (PDSB) announced the acceptance of its Clinical Trial Application (CTA) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the expansion of the VERSATILE-002 study. This study evaluates PDS0101 in combination with Merck’s KEYTRUDA (pembrolizumab). Enrollment in the UK is anticipated to begin in Q3 2022, marking a significant regulatory milestone. Preliminary safety data has been reported as highly encouraging, indicating the potential for expanding access to patients and expediting enrollment in this promising HPV-targeted immunotherapy.
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.