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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 (PDSB) has initiated an Investigator-Initiated Trial (ITT) for PDS0101, evaluating its efficacy alone and in combination with KEYTRUDA® in treating HPV-associated oropharyngeal cancer (HPV(+)OPSCC). This study, led by Mayo Clinic, aims to explore neoadjuvant treatment before surgery. HPV(+)OPSCC cases have been rising, with over 54,000 new occurrences expected annually in the US. PDS0101, a part of the Versamune® platform, is designed to enhance anti-tumor responses, potentially leading to better patient outcomes and understanding of the treatment's effectiveness.
PDS Biotechnology Corporation (Nasdaq: PDSB) has announced that its VERSATILE-002 Phase 2 study has achieved preliminary efficacy milestones for treating advanced HPV-associated head and neck cancer. The trial, evaluating PDS0101 in combination with Merck’s KEYTRUDA, will proceed with full enrollment of 54 patients after successfully demonstrating a tumor response in 4 out of the first 17 patients. This milestone underscores the potential of the Versamune platform to enhance CD8+ T-cell responses. Detailed results are expected to be shared at an upcoming medical conference.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced promising preclinical results for its universal flu vaccine, PDS0202, which utilizes the Infectimune™ and COBRA technologies. The vaccine demonstrated effective neutralization against multiple influenza strains, potentially offering long-lasting protection that could eliminate the need for yearly vaccinations. Conducted in collaboration with leading immunology experts, the studies showed robust immune responses, including the induction of memory T-cells. These advancements mark significant progress in the company's pipeline addressing infectious diseases.
PDS Biotechnology Corporation (Nasdaq: PDSB) will present at the B. Riley Securities Virtual Oncology Conference on January 28, 2022. The presentation will update on three ongoing phase 2 clinical trials involving PDS0101, in collaboration with MERCK & Co., targeting head and neck cancer. Other trials include studies for advanced HPV-associated cancers and locally advanced cervical cancer, led by NCI and MD Anderson Cancer Center respectively. Additionally, updates on PDS0102 and PDS0103, focusing on various cancers, will be provided. A webcast replay will be available post-conference.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced that initial safety data from its VERSATILE-002 study will be presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium on February 24-26, 2022. This Phase 2 study examines PDS0101 in combination with Merck’s KEYTRUDA for treating recurrent HPV16-positive head and neck cancer. The initial results have met the safety benchmark in the first 12 patients. PDSB is also engaged in further clinical studies for advanced HPV-associated cancers in collaboration with notable institutions.
PDS Biotechnology Corporation has received a granted U.S. patent for PDS0101, extending patent protection until October 2037. This immunotherapy combines the Versamune technology with protein fragments from the HPV16 virus, aimed at inducing T-cell responses against HPV16-related cancers. With over 40,500 annual diagnoses of HPV16-associated cancers, the company is optimistic about its early Phase 2 clinical trial results. PDS Biotech is collaborating with Merck to evaluate PDS0101 in combination with KEYTRUDA for head and neck cancer treatments.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced its management will present at the H.C. Wainwright Bioconnect Virtual Conference from January 10-13, 2022. The presentation will cover updates on three ongoing Phase 2 clinical trials for PDS0101 and the progression of PDS0102 and PDS0103 into human trials. A pre-recorded presentation will be available on January 10 at 7:00 am ET. Investors can register for the conference HERE.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced on December 20, 2021, that it granted an inducement equity award of 20,000 shares to Michael Lalond, the new Director of Quality Assurance. This grant, valued at an exercise price of $8.87 per share, is part of Mr. Lalond's employment compensation. The shares vest over four years, with the first quarter vesting on December 20, 2022. PDS Biotech focuses on developing immunotherapies using its proprietary Versamune® technology to enhance immune response against various cancers.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the resumption of recruitment for its Phase 2 clinical trial evaluating PDS0101 (Versamune®-HPV16) in advanced HPV cancers, following Institutional Review Board (IRB) approval. The trial, led by the National Cancer Institute (NCI), assesses the combination of PDS0101 with immune-modulating agents for patients who have not responded to standard therapies. The recruitment pause was administrative, and ongoing treatment for enrolled patients was uninterrupted. This trial aims to enhance clinical outcomes for those with limited options.
PDS Biotechnology Corporation (Nasdaq: PDSB) reported a net loss of approximately $7.0 million for Q3 2021, up from $3.9 million in Q3 2020. Research and development expenses increased to $3.7 million, driven by personnel and clinical study costs. The company's cash and cash equivalents stood at $69.7 million as of September 30, 2021. Progress was made in their VERSATILE-002 Phase 2 trial for PDS0101, with enrollment milestones achieved. PDS Biotech also announced a licensing agreement with the National Cancer Institute (NCI) and hired Matthew Hill as the new CFO.
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