Welcome to our dedicated page for Pds Biotechnology Corporation news (Ticker: PDSB), a resource for investors and traders seeking the latest updates and insights on Pds Biotechnology Corporation stock.
PDS Biotechnology Corporation (Nasdaq: PDSB) is a late-stage immunotherapy company developing investigational cancer therapies based on its Versamune® platform and IL-12 immunocytokine technology. News about PDS Biotech centers on the clinical and regulatory progress of its lead HPV16-targeted immunotherapy PDS0101 and its tumor-targeting IL-12 fused antibody drug conjugate PDS01ADC.
On this page, readers can follow company announcements on pivotal and mid-stage trials, including the VERSATILE-002 Phase 2 study and the VERSATILE-003 Phase 3 trial in HPV16-positive recurrent and/or metastatic head and neck squamous cell cancers. Updates often cover final survival and progression-free survival data, sub-analyses in specific patient subgroups such as low PD-L1 (CPS 1–19) cohorts, and efforts to align with the U.S. Food and Drug Administration on potential accelerated approval pathways.
PDS Biotech news also highlights translational research presented at scientific meetings like the Society for Immunotherapy of Cancer, where investigators have reported immune biomarker signatures, natural killer cell reprogramming, and expansion of stem-like memory T cells associated with PDS0101 and PDS01ADC. Additional coverage includes National Cancer Institute-led Phase 2 trials in metastatic colorectal and other advanced solid tumors, intellectual property developments such as new composition of matter patents for PDS0101, and capital markets events including registered direct offerings disclosed in Form 8-K filings.
Investors and observers who want to track PDSB can use this news feed to monitor clinical milestones, regulatory interactions, scientific data presentations, and financing activities that may influence the company’s development programs and overall outlook.
PDS Biotechnology Corporation (PDSB) announced the grant of nonstatutory stock options to Rory Cullinane, Vice President of Quality Assurance, for 70,000 shares at an exercise price of $3.62, the closing stock price on October 5, 2022. The options are part of PDSB’s 2019 Inducement Plan and will vest over four years, with one-quarter vesting after the first year. PDSB is focused on developing targeted immunotherapies for cancer and infectious diseases using its proprietary technology platforms, Versamune® and Infectimune™.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced acceptance of two abstracts for presentation at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on November 8-12, 2022. The studies focus on PDS0101, their lead candidate targeting HPV-expressing cancers. One study investigates PDS0101 combined with standard chemoradiotherapy for cervical cancer, while the other examines a triple combination therapy for HPV16-associated cancers. The research highlights the potential of PDS0101 and the Versamune technology in treating underserved cancer indications.
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.