Trilaciclib Dihydrochloride

Virtual Webinar Updated VERSATILE-002 Phase 2 Trial Results, Unmet Treatment Needs in Advanced Head and Neck Cancer and Planned Triple Combination Trial to be held May 8, 2024PRINCETON, N.J., May 03, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced additional details of its virtual Key Opinion Leader (KOL) event to be held on Wednesday, May 8, 2024 at 1:30 PM ET. To register for the event, click here. The virtual webinar will focus on the positive, updated data from the Company’s VERSATILE-002 Phase 2 clinical trial, current unmet need in HPV-positive head and neck cancer, and next steps for PDS Biotech’s planned triple combination trial including Versamune® HPV and PDS01ADC (IL-12 fused antibody drug conjugate). Panel participants will include: Jared Weiss, MD, Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at University of North Carolina, and Principal Investigator of the VERSATILE-002 clinical trial, who will present and discuss the updated trial resultsRobert Haddad, MD, Professor of Medicine, Harvard Medical School and Dana-Farber Cancer Institute, who will discuss the unmet need in HPV-positive head and neck squamous cell cancer (“HNSCC") The event will be moderated by Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer who will also present the next steps on the clinical path forward to registration for the Versamune® HPV and PDS01ADC based triple combination. The VERSATILE-002 trial (NCT04260126) is evaluating Versamune® HPV in combination with the immune checkpoint inhibitor (“ICI”) KEYTRUDA® (pembrolizumab) in patients with unresectable, recurrent, or metastatic HPV16-positive HNSCC. A live Q&A session will follow the formal presentations. About Jared Weiss, MDJared Weiss, MD received his undergraduate degree from Brown University and medical degree from Yale University. He completed residency at Harvard’s Beth Israel Deaconess Medical Center then fellowship at the Hospital of the University of Pennsylvania. He is currently employed as a tenured professor of medicine at UNC’s Lineberger Comprehensive Cancer Center where he also serves as section chief of thoracic and head/neck oncology. Dr. Weiss is proud to volunteer for and serve on the executive board of cancergrace.org and to advocate with the Lung Cancer Initiative of North Carolina. Dr. Weiss has published extensively, including in the New England Journal of Medicine, the Journal of Clinical Oncology and Lancet Oncology. He has played a role in the development of numerous approved agents, most recently including pembrolizumab, durvalumab, selpercatinib, trilaciclib and adagrasib. He has frequently presented at international conferences, including the Presidential Session of the European Society of Medical Oncology and Plenary Session of the Multidisciplinary Head and Neck Cancer Symposium. Dr. Weiss’s clinical practice is focused on lung cancer and head/neck cancer. Dr. Weiss’s research is focused on personalized and adaptive immunotherapy to treat cancer (neo-antigen cancer vaccines and cellular therapeutics). He has particular interest in small-cell lung cancer and in NUT carcinoma. About Robert Haddad, MDRobert Haddad, MD is Professor of Medicine, Harvard Medical School, Division Chief and Institute Physician, Center of Head and Neck Oncology Program, and a member of the Department of Adult Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts. Dr. Haddad received his medical degree from Saint Joseph University, French Faculty of Medicine, and served as intern and resident at St. Luke’s Roosevelt Hospital Center, New York, New York. He completed his fellowship in hematology/oncology at Greenbaum Cancer Center, University of Maryland, Baltimore, Maryland. Dr. Haddad is a member of several professional societies, including the American Society of Clinical Oncology, American Association for Cancer Research and the American Society for Therapeutic Radiology and Oncology. Dr Haddad research is focused on identifying innovative forms of treatment in Head and Neck Cancer. His research activities involve the use of induction chemotherapy for patients with locally advanced head and neck cancer and the development of novel immunotherapeutic agents for treating locally advanced disease. He has been instrumental in the development, execution and publication of numerous phase II and III trials in head and neck cancer. These trials have advanced the field of head and neck oncology and have resulted in new therapies for patients. Dr Haddad is also involved in teaching oncology fellows as well as medical residents, and ENT residents through the Dana-Farber Cancer Institute outpatient clinic and Brigham and Women’s Hospital inpatient service. He lectures extensively on head and neck cancer at the local, regional, national and international levels and has been invited to lecture in prestigious institutions and at national and international forums. He has presented his work at important scientific meetings such as the American Society of Clinical Oncology (ASCO) and the American Head and Neck Society Meeting (AHNS) and has edited two textbooks on head and neck cancer. Dr Haddad has an active role in the national comprehensive cancer network (NCCN) where he participates as a committee member in the head and neck committee and chair of the thyroid cancer committee. In this capacity, He helps write treatment guidelines. He has authored more than 200 publications related to Head and Neck cancer. About PDS BiotechnologyPDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced head and neck squamous cell cancers (HNSCC). PDS Biotech’s lead program is a proprietary dual-acting combination of IL-12 fused antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune® HPV in regimen with a standard-of-care immune checkpoint inhibitor. We believe that proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability. We believe that with a novel investigational “inside-outside” mechanism, the PDS01ADC and Versamune® HPV immunotherapy has shown compelling results with potential to successfully disrupt a tumor’s inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside. We believe that data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the potential for both platforms and point to potential broad utility. Our Infectimune® based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. For more information, please visit www.pdsbiotech.com. Forward Looking StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. Keytruda® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA. Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: mmoyer@lifesciadvisors.com Media Contact:Gina Mangiaracina6 DegreesPhone +1 (917) 797-7904Email: gmangiaracina@6degreespr.com