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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) 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.
PDS Biotechnology Corporation (PDSB), a clinical-stage immunotherapy firm, announced on October 19, 2021, the granting of nonstatutory stock options to key personnel including CFO Matthew Hill and others. The options allow the purchase of shares at an exercise price of $12.03, based on the stock's closing price on the grant date. Each option vests over four years, promoting long-term employment. The company focuses on developing cancer immunotherapies utilizing its Versamune® technology, aiming to enhance T-cell responses against various cancers.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced a temporary suspension of recruitment in the Phase 2 clinical trial (NCT04287868) for PDS0101, evaluating its potential in advanced HPV cancers. This decision is not due to safety or efficacy concerns but rather administrative issues. The National Cancer Institute expects the recruitment to resume shortly without affecting the clinical data timeline. Interim data suggests PDS0101 may significantly improve outcomes for patients with limited options.
PDS Biotechnology Corporation (Nasdaq: PDSB) plans to release its third-quarter 2021 financial results on November 10, 2021, before market opening. Following the release, management will conduct a conference call at 8:00 am ET to discuss the results and provide a business update. PDS Biotech focuses on developing innovative cancer therapies using its proprietary Versamune® T-cell activating technology, targeting various cancers like breast and lung. The conference call can be accessed via phone or a live webcast on the company's investor relations page.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced Matthew Hill as the new Chief Financial Officer, effective October 18, 2021. Hill, with over 25 years of experience in finance within life sciences, previously held the CFO role at Strata Skin Sciences. He aims to guide PDS Biotech's financial strategy in a critical growth phase, especially with its proprietary Versamune® technology for cancer therapies. The company acknowledges the contribution of outgoing CFO Seth Van Voorhees. PDS Biotech focuses on developing innovative cancer treatments targeting several cancer types.
PDS Biotechnology Corporation (Nasdaq: PDSB) has completed enrollment for the first stage of the checkpoint inhibitor naïve arm in its VERSATILE-002 Phase 2 study targeting recurrent HPV16-associated head and neck cancer. This ambitious trial aims to assess the efficacy of PDS0101, in collaboration with Merck & Co. A significant milestone was achieved as objective response will be evaluated based on tumor reduction. If four out of the first 17 patients show positive results, the study will progress to the second stage involving 54 additional patients.
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