- Preliminary update on the efficacy and safety of PDS0101 in combination with KEYTRUDA® (Pembrolizumab) for first-line recurrent or metastatic HPV-positive head and neck cancer
- NCI Preliminary Efficacy and Safety Update on the PDS0101-Based Triple Combination in Advanced Refractory HPV-Associated Cancers
FLORHAM PARK, NJ, April 27, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the company’s Versamune® and Infectimune™ T-cell activation technologies, today announced the titles of two abstracts accepted for poster presentations at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 3-7, 2022.
Poster Presentation Abstract #6041 summarizes updates to the preliminary efficacy and safety data from the PDS Biotechnology-sponsored Phase 2 clinical trial VERSATILE-002 evaluating PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of recurrent or metastatic HPV16-positive head and neck cancer. This study is designed to treat both checkpoint inhibitor (CPI)-naïve and refractory patients. PDS Biotech previously announced that the study reached its preliminary efficacy milestone in the CPI-naïve arm earlier this year and presented detailed preliminary safety data at the 2022 Multidisciplinary Head and Neck Cancers Symposium.
Abstract number: 6041
Title of the abstract: PDS0101, a novel type 1 interferon and CD8+ T-cell activating immunotherapy in combination with pembrolizumab in patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC).
Presenting Author: Jared Weiss, MD, Department Chair in Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, who is serving as the Lead Principal Investigator for VERSATILE-002
Session title: head and neck cancer
Session date and time: Monday, June 6, 2022 at 1:15 – 4:15 p.m. CDT
The poster discussion presentation of abstract #2518 summarizes the results of the ongoing National Cancer Institute (NCI)-led Phase 2 clinical trial evaluating PDS0101 in combination with two investigational immunomodulating compounds. This news follows the achievement of the enrollment target of 30 patients in the CPI-refractory arm, announced in March. NCI will continue to enroll both CPI-refractory and naïve patients until the enrollment goal of 56 patients is met.
Abstract number: 2518
Title of the abstract: Phase II evaluation of the combination of PDS0101, M9241 and bintrafusp alfa in patients with HPV 16+ malignancies.
Presenting Author: James Gulley, Ph.D., National Cancer Institute
Session title: Poster Discussion Session / Developmental Therapeutics – Immunotherapy
Session date and time: Sunday, June 5, 2022, 8:00 a.m. – 11:00 a.m.; 11:30 a.m. – 1:00 p.m. CDT
Patients interested in participating in the NCI-led clinical trial should call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615). and email NCIMO_Referrals @mail.nih.gov and/or visit: https://trials.cancer.gov.
Abstracts will be available on Thursday, May 26, 2022 at 5:00 p.m. EDT ASCO.org.
“We are pleased to have the opportunity to provide updates on two of our PDS0101 clinical programs at this year’s ASCO Annual Meeting,” commented Dr. Lauren V. Wood, MD, Chief Medical Officer at PDS Biotech. “ASCO offers PDS Biotech a unique opportunity to update the scientific community on our ongoing Phase 2 trials and the potential of Versamune® platform in immuno-oncology.”
KEYTRUDA® is a registered trademark of Merck Sharp and Dohme Corp., a subsidiary of Meck & Co., Inc. Kenilworth, NJ USA.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted immunotherapies for cancer and infectious diseases based on the company’s Versamune® and Infectimune™ T-cell activating technology platforms. Our versamune®-based products have shown the potential to overcome the limitations of current induction-based immunotherapy in vivo, large quantities of high-quality, highly potent polyfunctional tumor-specific CD4+ helper and CD8+ killer T cells. PDS Biotech has developed several therapies based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products treat multiple cancers, including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar), breast, colon, lung, prostate and cancer ovarian cancer.
Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also potent T-cell responses, including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
This release 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) with respect to PDS Biotechnology Corporation (the “Companies “) and other matters. These statements may discuss goals, intentions and expectations regarding 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 and information currently available, management. Forward-looking statements generally include statements that are forward-looking in nature and depend on or relate to future events or conditions and contain words such as “may”, “will”, “should”, “would”, “expects”, “anticipates” . ”, “plan”, “likely”, “believe”, “estimate”, “forecast”, “intend”, “forecast”, “guidance”, “outlook” and other similar expressions. 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 statements due to a number of 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 liquidity needs and the company’s current expectations regarding its plans for future equity financing; the Company’s dependence on additional financing to fund its operations and to complete the development and commercialization of its product candidates and the risks that raising such additional capital could limit the Company’s operations or require the Company to acquire rights to the technologies or product candidates of the give up company; 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 a business plan; the timing for the Company or its partners to initiate planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates; the future success of such attempts; the successful implementation of the Company’s research and development programs and collaborations, including all collaboration studies related to 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 recruitment and completion of the trials (including the Company’s ability to to fully fund its disclosed clinical trial (which requires no material changes to our current projected expenditures), futility analysis, conference presentations and data reported in an abstract, and receipt of interim results (including, but not limited to, any pre-clinical results or data) not necessarily indicative of the definitive results of the Company’s ongoing clinical trials; all statements by the Company regarding its understanding of the mechanisms of action of product candidates and the interpretation of pre-clinical and early clinical results from its clinical development programs and collaborative studies; and other factors, including legal, regulatory, political and economic developments beyond the Company’s control, including unforeseen circumstances or other disruptions to normal business operations, arising out of or related to COVID-19. The foregoing summary 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 contained herein and elsewhere, including the risk factors contained in The Company’s annual and interim reports filed with us include the S. The forward-looking statements are made only as of the date of this press release and, except as required by law, the Company undertakes no obligation to revise or update any forward-looking statements or to endorse any other forward-looking statements whether as a result of new information, future events or any other reason.
Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.
Telephone: +1 (404) 736-3838
E-mail: [email protected]