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PDS Biotechnology Corporation reports developments in targeted cancer immunotherapies based on its Versamune platform. Company news centers on PDS0101, also called Versamune HPV, in HPV16-positive head and neck cancer, and on PDS01ADC, an IL-12 fused antibody drug conjugate and tumor-targeted immunocytokine evaluated across multiple solid tumor indications.
Recurring updates include clinical-trial data, National Cancer Institute-led study presentations, FDA and IND protocol communications, scientific publications, patent coverage for core technology, quarterly financial results, and broader corporate-program updates.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the granting of stock options to key personnel as an inducement for their employment. On April 6, 2022, the company granted 70,000 options to Dr. Robert Imani and 50,000 options to Paul Ivany, with an exercise price set at $6.09, the closing stock price on that date. The options will vest over four years, contingent on continued employment. PDS Biotech focuses on developing cancer immunotherapies and infectious disease vaccines using its proprietary technologies, Versamune® and Infectimune™.
PDS Biotechnology Corporation (Nasdaq: PDSB) reported a net loss of approximately $16.9 million for 2021, compared to $14.8 million in 2020. The increase in losses was driven by higher research and development costs of $11.3 million and general and administrative expenses of $10.2 million. The company achieved significant clinical milestones, including progress on PDS0101 in ongoing Phase 2 trials and encouraging preclinical data for its flu vaccine. With a cash balance of $65.2 million, PDSB expects to fund operations through 2023.
PDS Biotechnology Corporation (Nasdaq: PDSB) has rescheduled its 2021 fourth quarter and full-year earnings release and conference call to March 31, 2022, at 8:00 AM EDT. The delay is attributed to the need for additional time to complete its audit and file the Annual Report on Form 10-K for the fiscal year ending December 31, 2021. The conference call will review financial results and provide a business update. Investors can access the call via a live webcast on PDS Biotech’s website.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced that the National Cancer Institute (NCI) has enrolled 30 patients in the checkpoint inhibitor (CPI) refractory arm of a Phase 2 clinical trial for PDS0101 targeting advanced HPV-associated cancers. The study aims for a total of 56 participants, evaluating efficacy in both CPI refractory and CPI naïve patients. Promising survival data was previously reported, with median survival now exceeding 12 months. An update from the NCI is anticipated soon.
PDS Biotechnology Corporation (Nasdaq: PDSB) will release financial results for the year ended December 31, 2021, on March 23, 2022, before market opening. The company specializes in immunotherapy, utilizing proprietary Versamune® and Infectimune™ technologies to develop cancer therapies and infectious disease vaccines. Following the release, a conference call will occur at 8:00 AM EDT for a financial review and business updates. Investors can join via phone or a live webcast available on the company's website.
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.