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PDS Biotechnology Corporation (NASDAQ: PDSB) delivers innovative immunotherapies through its Versamune® platform, targeting cancers and infectious diseases. This news hub provides investors and researchers with timely updates on clinical advancements, regulatory milestones, and corporate developments.
Access primary-source press releases and curated analysis covering PDSB's clinical trials, partnership announcements, and financial disclosures. Track progress across key areas: Phase II/III oncology studies, FDA communications, and strategic collaborations enhancing their nanoparticle-based therapies.
Our repository ensures you stay informed about critical developments in HPV-associated cancer treatments, combination therapy research, and infectious disease vaccine progress. Bookmark this page for direct access to PDSB's verified updates, eliminating the need to scour multiple sources.
PDS Biotechnology Corporation (Nasdaq: PDSB) has selected checkpoint inhibitor (CPI) refractory patients for its ongoing Phase 2 clinical trial of PDS0101-based triple combination therapy for advanced HPV-positive cancers. This decision follows data indicating a 77% survival rate at a median follow-up of 12 months. The trial, led by the National Cancer Institute, plans to meet with the FDA regarding the therapy's registration path. Enrollment for CPI naïve patients has been halted to focus on the CPI refractory group due to unmet medical needs and promising efficacy signals.
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company, will present at the H.C. Wainwright 24th Annual Global Investment Conference in New York City from September 12-14, 2022. The company's presentation is scheduled for September 12 at 7:00 AM EDT. PDSB focuses on developing cancer immunotherapies and vaccines using its proprietary Versamune® and Infectimune™ technologies. Webcast registration is available online, and a replay will be accessible on PDSB's investor website after the event.
PDS Biotechnology Corporation (Nasdaq: PDSB) has secured a $35 million debt financing agreement led by Horizon Technology Finance Corporation. The initial tranche of $25 million will support the registrational trial for their lead candidate, PDS0101, as well as other clinical developments. PDSB's CEO expressed optimism about advancing their oncology and infectious disease programs. The loan has a repayment period of 48 months.
A conference call is scheduled for August 25, 2022, at 8:00 AM EDT to discuss further details.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the safety evaluation results of PDS0101 in combination with KEYTRUDA for treating recurrent or metastatic HPV16-positive head and neck cancer. The independent Data Monitoring Committee (DMC) reviewed data from 43 patients, reporting no treatment-related adverse events of Grade 3 or higher. The DMC recommended continuing the trial without modifications. The combination therapy is evaluated in the ongoing VERSATILE-002 trial, which has shown promising preliminary efficacy data, including an 87% overall survival rate at 9 months.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced its participation in the upcoming BTIG Biotechnology Conference on August 8-9, 2022. This hybrid event will feature a fireside chat and one-on-one meetings with management, showcasing the company’s immunotherapy advancements. PDS Biotech focuses on developing targeted cancer therapies and infectious disease vaccines using its proprietary Versamune® and Infectimune™ technologies. The company aims to enhance immune responses against various cancers, including HPV16-associated types and others.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the release of its second-quarter 2022 financial results on August 8, 2022, before market opening. The company, known for developing cancer immunotherapies and infectious disease vaccines using its proprietary Versamune® and Infectimune™ technologies, will host a conference call at 8:00 AM EDT the same day to discuss the results and provide updates on its business. Investors can access the call via phone or through a webcast.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced significant preclinical results for its investigational universal flu vaccine, PDS0202, which neutralized multiple influenza strains. In studies, animals vaccinated with PDS0202 showed significantly higher antibody levels against H1 and H3 strains and exhibited 100% survival against the H1N1 pandemic strain, unlike those with lower survival rates. The combination of Infectimune™ and COBRA antigens allowed for effective protection using 25-fold lower doses, indicating potential for a broad-spectrum influenza vaccine.
PDS Biotechnology Corporation (Nasdaq: PDSB) has appointed Spencer Brown as its new Senior Vice President and General Counsel. Brown brings extensive experience from top biotech and pharmaceutical companies, enhancing PDS Biotech's legal and compliance framework. As part of his inducement package, he received stock options for 150,000 shares at an exercise price of $4.22, which will vest over four years. This leadership change aims to support PDS Biotech’s growth in developing cancer immunotherapies and infectious disease vaccines using its proprietary platforms.
PDS Biotech announced that the FDA has granted Fast Track designation for PDS0101 in combination with KEYTRUDA® for treating recurrent or metastatic HPV16-positive head and neck cancer. This designation aims to expedite the development and review of the therapy, which shows potential in addressing a significant medical need. The ongoing Phase 2 VERSATILE-002 trial evaluates the effectiveness of this combination treatment. PDS0101 leverages the Versamune® platform and aims to improve outcomes for patients with limited treatment options.
PDS Biotechnology Corporation (PDSB) announced the acceptance of its Clinical Trial Application (CTA) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the expansion of the VERSATILE-002 study. This study evaluates PDS0101 in combination with Merck’s KEYTRUDA (pembrolizumab). Enrollment in the UK is anticipated to begin in Q3 2022, marking a significant regulatory milestone. Preliminary safety data has been reported as highly encouraging, indicating the potential for expanding access to patients and expediting enrollment in this promising HPV-targeted immunotherapy.