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PDS Biotechnology Corporation (Nasdaq: PDSB) is a clinical stage biopharmaceutical company focused on developing next-generation immunotherapies for cancer and infectious diseases. The company's proprietary Versamune® platform leverages synthetic and biodegradable lipids to form nanoparticles that are readily taken up by the immune system. These nanoparticles are designed to activate and direct the immune system to target and eliminate disease-causing cells.
PDS Biotech's lead product candidates include PDS0101, targeting HPV-related cancers, and PDS01ADC, an IL-12 fused antibody drug conjugate. These candidates are part of the company's broader strategy to treat a range of cancers, including head and neck, prostate, breast, cervical, and anal cancers.
Recent achievements include the completion of a Phase 1 clinical trial for PDS0101 and ongoing Phase 2 trials demonstrating positive survival results and tumor shrinkage. The company is preparing to initiate a pivotal clinical trial in advanced head and neck cancers in 2024.
Financially, PDS Biotech reported a net loss of $10.8 million for Q3 2023, primarily due to increased R&D and administrative expenses. Despite this, the company remains focused on advancing its pipeline and has several key partnerships to support its research and development efforts.
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.
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.
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