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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 appointment of Seth Van Voorhees, Ph.D. as the new Chief Financial Officer, effective January 1, 2021. Dr. Van Voorhees brings extensive experience in corporate finance, investment banking, and licensing, previously serving as CFO at Research Frontiers and American Pacific. CEO Frank Bedu-Addo highlighted this as a pivotal moment for the company, with opportunities ahead leveraging its proprietary Versamune® technology platform. The transition follows the interim role of Michael King, whose contributions were acknowledged.
PDS Biotechnology Corporation (Nasdaq: PDSB) has been granted U.S. Patent No. 10,828,364 for its Versamune® platform. This patent includes methods for reducing myeloid derived suppressor cell (MDSC) populations, which hinder immune responses, via cationic lipid vaccine compositions. The patent solidifies protections for the Versamune® platform, enhancing its potential for improved clinical outcomes in ongoing mid-stage trials of PDS0101, targeting HPV-related cancers. Additionally, the U.S. Government retains certain rights due to prior support from the National Cancer Institute.
PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company, announced that CEO Dr. Frank Bedu-Addo will present at the virtual Fall Investor Summit on November 16, 2020, at 10:30 AM Eastern Time. This event features 75 companies and connects them with over 300 institutional and retail investors. A replay of the presentation will be available in the investor relations section of the Company’s website. PDS Biotech specializes in cancer therapies and infectious disease vaccines using its proprietary Versamune technology.
PDS Biotechnology Corporation (Nasdaq: PDSB) reported Q3 2020 financial results, revealing a net loss of approximately $3.9 million, or $0.23 per share, a decrease from a $5.8 million loss in Q3 2019. R&D expenses rose by 12% to $2.1 million, while general and administrative costs dropped by 40% to $1.8 million. The company successfully raised $19 million in a public offering and initiated several Phase 2 trials for its investigational drug PDS0101. As of September 30, 2020, cash reserves stood at $33.5 million.
PDS Biotech has prioritized the clinical development of PDS0203, a Versamune®-based COVID-19 vaccine, following a successful meeting with Brazil's drug regulatory agency, ANVISA. The vaccine aims to elicit strong immune responses, showing a 30-45 fold increase in T-cell activation compared to standard vaccines. PDS Biotech and Farmacore plan to begin human trials in the first half of 2021, backed by promising preclinical data. Both companies will collaborate on regulatory efforts, with Farmacore leading in Brazil.
PDS Biotechnology Corporation has launched the VERSATILE-002 Phase 2 trial, assessing the combination of PDS0101 and KEYTRUDA® for first-line treatment of recurrent or metastatic head and neck cancer. This multi-center trial aims to enroll around 100 patients across 25 sites in the U.S., with the University of Tennessee Medical Center as the first site. The study evaluates the efficacy and safety of PDS0101, targeting HPV-associated cancers. The primary endpoint is the objective response rate at nine months. This trial marks a significant step in the collaboration with Merck.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the appointment of Dr. Otis Brawley to its Board of Directors. Dr. Brawley, an esteemed oncologist with extensive experience in oncology and pharmaceutical development, is currently the Bloomberg Distinguished Professor at Johns Hopkins University. His past roles include Chief Medical and Scientific Officer at the American Cancer Society and member of the FDA Oncologic Drug Advisory Committee. The company highlights that Dr. Brawley's expertise will be crucial as PDS Biotech advances its clinical programs.
PDS Biotechnology Corporation (Nasdaq: PDSB) has announced its participation in the "Grand Rounds: a Webinar in Biotech and Specialty Pharma" on November 2, 2020, hosted by Alliance Global Partners. This presentation will showcase the company's proprietary Versamune® technology used in cancer therapies and infectious disease vaccines.
The company will also report its third quarter 2020 financial results on November 11, 2020, followed by a conference call on November 12, 2020, at 8:00 am Eastern Time to discuss the results and provide a business update.
PDS Biotech has initiated a Phase 2 clinical trial for PDS0101 combined with standard chemoradiotherapy (CRT) to treat locally advanced cervical cancer. The study, led by MD Anderson Cancer Center, will evaluate the safety and anti-tumor efficacy of this combination in approximately 35 patients. The trial aims to correlate the treatment’s effectiveness with biomarkers of immune response. Dr. Lauren Wood, the Chief Medical Officer, expresses optimism regarding the potential of PDS0101 in enhancing cervical cancer treatments.
PDS Biotechnology Corporation (PDSB), a clinical-stage immunotherapy firm, announced the virtual presentations of its CEO, Frank Bedu-Addo, at notable investment conferences. The H.C. Wainwright & Co. 22nd Annual Global Investment Conference is set for September 16, 2020, at 2:30 PM ET, and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit is on September 23, 2020, at 4:10 PM ET. The company specializes in innovative cancer therapies and vaccines, utilizing its proprietary Versamune® technology. A replay of the Oppenheimer presentation will be available for 90 days.
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