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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 successful completion of an End-of-Phase 2 meeting with the FDA regarding PDS0101, in combination with Merck's KEYTRUDA®, for treating HPV16-positive head and neck cancer. FDA guidance paves the way for a Biologics License Application. Earlier, the FDA granted Fast Track designation for this combination, expediting its review process. PDS0101 has shown promising interim results, with 77% of patients stabilizing or shrinking tumors. This leads to an anticipated quicker transition into registrational trials.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the granting of nonstatutory stock options to key personnel as an inducement for their employment. Amber King received options for 5,000 shares, Charliene Casey for 12,000 shares, and David Schaaf for 70,000 shares, with an exercise price of $3.18, equal to the stock's closing price on September 22, 2022. The options will vest over four years, subject to continued employment. PDSB is focused on developing targeted immunotherapies for cancer and infectious diseases, utilizing its proprietary Versamune and Infectimune technology platforms.
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company, announces that Dr. Frank Bedu-Addo, President and CEO, will participate in a panel at Cantor Fitzgerald’s Oncology & HemOnc Conference on September 28, 2022, at 1:45 PM EDT. The panel will focus on trends and challenges in immuno-oncology. PDS Biotech is developing targeted immunotherapies based on its Versamune® and Infectimune™ technology platforms, showing potential in treating HPV16-associated cancers and producing robust T cell responses.
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.
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