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 (Nasdaq: PDSB) announced its participation in the Oppenheimer 32nd Annual Virtual Healthcare Conference on March 15, 2022. The presentation will cover updates on four PDS0101 phase 2 clinical trials, including studies on head and neck cancer and HPV-associated cancers, in collaboration with prominent institutions like MERCK & Co. and MD Anderson Cancer Center. Additionally, updates on two investigational products and the company’s Infectimune™ pipeline will be shared. A webcast replay will be available post-conference on the company’s website.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced preliminary safety data from its VERSATILE-002 Phase 2 trial, evaluating PDS0101 in combination with KEYTRUDA for treating recurrent or metastatic HPV16-positive head and neck cancer. The trial involved 18 patients and showed no significant toxicity or dose-limiting toxicities. The study's accrual is ongoing, with promising preliminary efficacy results already reported. The company is also conducting additional clinical studies for various HPV-related cancers.
PDS Biotechnology Corporation (PDSB) has initiated an Investigator-Initiated Trial (ITT) for PDS0101, evaluating its efficacy alone and in combination with KEYTRUDA® in treating HPV-associated oropharyngeal cancer (HPV(+)OPSCC). This study, led by Mayo Clinic, aims to explore neoadjuvant treatment before surgery. HPV(+)OPSCC cases have been rising, with over 54,000 new occurrences expected annually in the US. PDS0101, a part of the Versamune® platform, is designed to enhance anti-tumor responses, potentially leading to better patient outcomes and understanding of the treatment's effectiveness.
PDS Biotechnology Corporation (Nasdaq: PDSB) has announced that its VERSATILE-002 Phase 2 study has achieved preliminary efficacy milestones for treating advanced HPV-associated head and neck cancer. The trial, evaluating PDS0101 in combination with Merck’s KEYTRUDA, will proceed with full enrollment of 54 patients after successfully demonstrating a tumor response in 4 out of the first 17 patients. This milestone underscores the potential of the Versamune platform to enhance CD8+ T-cell responses. Detailed results are expected to be shared at an upcoming medical conference.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced promising preclinical results for its universal flu vaccine, PDS0202, which utilizes the Infectimune™ and COBRA technologies. The vaccine demonstrated effective neutralization against multiple influenza strains, potentially offering long-lasting protection that could eliminate the need for yearly vaccinations. Conducted in collaboration with leading immunology experts, the studies showed robust immune responses, including the induction of memory T-cells. These advancements mark significant progress in the company's pipeline addressing infectious diseases.
PDS Biotechnology Corporation (Nasdaq: PDSB) will present at the B. Riley Securities Virtual Oncology Conference on January 28, 2022. The presentation will update on three ongoing phase 2 clinical trials involving PDS0101, in collaboration with MERCK & Co., targeting head and neck cancer. Other trials include studies for advanced HPV-associated cancers and locally advanced cervical cancer, led by NCI and MD Anderson Cancer Center respectively. Additionally, updates on PDS0102 and PDS0103, focusing on various cancers, will be provided. A webcast replay will be available post-conference.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced that initial safety data from its VERSATILE-002 study will be presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium on February 24-26, 2022. This Phase 2 study examines PDS0101 in combination with Merck’s KEYTRUDA for treating recurrent HPV16-positive head and neck cancer. The initial results have met the safety benchmark in the first 12 patients. PDSB is also engaged in further clinical studies for advanced HPV-associated cancers in collaboration with notable institutions.
PDS Biotechnology Corporation has received a granted U.S. patent for PDS0101, extending patent protection until October 2037. This immunotherapy combines the Versamune technology with protein fragments from the HPV16 virus, aimed at inducing T-cell responses against HPV16-related cancers. With over 40,500 annual diagnoses of HPV16-associated cancers, the company is optimistic about its early Phase 2 clinical trial results. PDS Biotech is collaborating with Merck to evaluate PDS0101 in combination with KEYTRUDA for head and neck cancer treatments.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced its management will present at the H.C. Wainwright Bioconnect Virtual Conference from January 10-13, 2022. The presentation will cover updates on three ongoing Phase 2 clinical trials for PDS0101 and the progression of PDS0102 and PDS0103 into human trials. A pre-recorded presentation will be available on January 10 at 7:00 am ET. Investors can register for the conference HERE.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced on December 20, 2021, that it granted an inducement equity award of 20,000 shares to Michael Lalond, the new Director of Quality Assurance. This grant, valued at an exercise price of $8.87 per share, is part of Mr. Lalond's employment compensation. The shares vest over four years, with the first quarter vesting on December 20, 2022. PDS Biotech focuses on developing immunotherapies using its proprietary Versamune® technology to enhance immune response against various cancers.