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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) 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.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced a licensing agreement with the National Cancer Institute for TARP-related intellectual property to enhance its oncology pipeline. Approximately 470,000 patients are expected to be diagnosed with TARP-associated cancers annually. PDS0102, utilizing the Versamune® technology with TARP, has shown promising preclinical results by inducing tumor-targeted T-cells. The license ensures patent protection until 2034, indicating strong growth potential in treating cancers like acute myeloid leukemia, prostate, and breast cancer.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced a licensing agreement with the University of Georgia for COBRA antigens, which will be integrated into its infectious disease immunotherapy pipeline, specifically PDS0202, a candidate for a universal flu vaccine. This partnership aims to enhance PDSB's Versamune® T-cell activating technology, addressing the global issue of seasonal influenza. The potential of PDS0202 lies in its ability to generate a robust immune response against multiple influenza strains, which could significantly reduce annual flu cases.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced that Dr. Lauren V. Wood, Chief Medical Officer, will present at the 2021 International Head and Neck Cancer Conference from November 2-4, 2021. The seminar titled "New Drugs in the Fight Against Head & Neck Cancer" will focus on innovative treatment methods for head and neck cancer, featuring PDSB's proprietary Versamune® technology and its potential impact on HPV-associated cancers. The conference aims to enhance collaboration among health professionals, patients, and drug companies in cancer research and treatment.