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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 that its abstract, featuring updated data from the VERSATILE-002 study, has been selected for presentation at the 2023 ASCO Annual Meeting on June 5, 2023. This Phase 2 study investigates the safety and efficacy of PDS0101 combined with KEYTRUDA® in treating patients with HPV16-positive head and neck cancer. The study focuses on two groups: ICI-naïve and ICI-refractory patients. Preliminary results show that 77% of patients had disease stabilization or tumor shrinkage, with an 87% overall survival rate at 9 months. The presentation will be part of the Head and Neck Cancer session, highlighting PDS0101's potential as a targeted therapy for this growing patient demographic.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced it received $1.4 million from the sale of tax benefits to a profitable New Jersey corporation under the New Jersey Technology Business Tax Certificate Transfer program for State Fiscal Year 2021. This funding is crucial as the company transitions its lead asset, PDS0101, into a registrational trial aimed at treating HPV16-positive metastatic or recurrent head and neck cancer. The New Jersey program allows unprofitable tech companies to sell a portion of their net operating losses and R&D tax credits to profitable entities, turning tax credits into cash to support growth, R&D, and operations. PDS Biotech focuses on developing targeted immunotherapies for cancer and infectious diseases utilizing proprietary platforms like Versamune®.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced a Key Opinion Leader (KOL) Roundtable focusing on Interleukin-12 (IL-12) on April 21, 2023, from 8:00 to 9:00 AM ET. This event will explore the potential of PDS0301, a novel IL-12 fusion protein, in oncology. The roundtable, moderated by Dr. Lauren Wood, will feature presentations from notable experts including Dr. James Gulley and Dr. Jeffrey Schlom. PDS0301 aims to enhance T cell activity in the tumor microenvironment while minimizing systemic exposure, thus promising improved safety and tolerability. Registration is open, and a live webcast will be available on the company’s investor relations website. PDS Biotechnology is committed to advancing targeted immunotherapies for cancer and infectious diseases, with PDS0101 entering Phase 3 trials in 2023.
PDS Biotech announced plans to advance PDS0101 into a Phase 3 clinical trial named VERSATILE-003, targeting HPV16-positive recurrent and/or metastatic head and neck cancer in 2023. This initiative aligns with Oral, Head & Neck Cancer Awareness Month in April. The Phase 3 trial follows positive results from a Phase 2 study, which indicated a 41% objective response rate and an 87% overall survival rate at nine months. The combination therapy of PDS0101 with KEYTRUDA received Fast Track designation from the FDA, underscoring its potential in addressing a significant unmet medical need.
PDS Biotechnology Corporation (PDSB) has completed Phase 3 manufacturing of PDS0101 for a registrational trial in recurrent/metastatic HPV16-positive head and neck cancer. The VERSATILE-003 trial will compare PDS0101 in combination with KEYTRUDA® against KEYTRUDA® alone, aiming to start in Q4 2023. An amended IND application will be submitted to the FDA in Q3 2023. Phase 2 data showed a 41% objective response rate and an 87% overall survival rate at nine months for the combination, with no severe adverse events reported. The trial represents a significant milestone, addressing the critical need for new treatments in head and neck cancer.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced participation in Cantor’s Future of Oncology Virtual Symposium from April 3-5, 2023. Dr. Frank Bedu-Addo, President and CEO, will present on April 4 at 3:00 PM ET. The company focuses on developing targeted immunotherapies for cancer and infectious diseases through innovative platforms like Versamune® and Infectimune™. Their lead candidate, PDS0101, has shown promise in treating HPV16-associated cancers, demonstrating tumor reduction and disease stabilization. PDS Biotech aims to enhance immunotherapy effectiveness by optimizing T cell responses.
PDS Biotechnology Corporation (NASDAQ: PDSB) announced a successful meeting with the FDA, discussing the registrational pathway for a triple combination treatment involving PDS0101, PDS0301, and a commercial immune checkpoint inhibitor. Preliminary results from the IMMUNOCERV trial showed 100% clinical response in high-risk cervical cancer patients.
In 2022, the company reported a net loss of $40.9 million, a significant increase from $16.9 million in 2021, primarily due to R&D investments. The cash balance as of December 31, 2022, was $73.8 million, expected to fund operations through Q3 2024.
PDS Biotechnology Corporation (Nasdaq: PDSB) is set to release its financial results for Q4 2022 on March 28, 2023, before market opening. A conference call will follow to discuss these results and provide a business update. The company is developing targeted immunotherapies for cancer and infectious diseases, utilizing its proprietary platforms, Versamune® and Infectimune™. Their lead candidate, PDS0101, has shown promise in reducing tumors in HPV16-related cancers. The conference call will be accessible via domestic and international numbers and a webcast will be archived for six months.
PDS Biotechnology Corporation (Nasdaq: PDSB), an innovative clinical-stage immunotherapy company, announced that its CEO, Dr. Frank Bedu-Addo, will present at the 33rd Annual Oppenheimer Healthcare Conference on March 14, 2023, at 8:00 AM ET. The event will be held virtually, and investors can register for the webcast here. PDS Biotech focuses on targeted immunotherapies for cancer and infections, leveraging proprietary platforms like Versamune® and Infectimune™. Their lead candidate, PDS0101, has shown promise in Phase 2 trials for HPV16-associated cancers.
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