On April 27, 2022 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 proprietary Versamune and Infectimune T-cell activating technologies, reported the titles of two abstracts accepted for poster presentations during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held from June 3-7, 2022 (Press release, PDS Biotechnology, APR 27, 2022, View Source [SID1234613035]).
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Abstract # 6041 poster presentation summarizes updates to the preliminary efficacy and safety data from the PDS Biotechnology sponsored VERSATILE-002 Phase 2 clinical trial, which is studying 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 trial is designed to treat both checkpoint inhibitor (CPI) naïve and refractory patients. PDS Biotech previously announced that the trial had achieved its preliminary efficacy milestone in the CPI naive arm earlier this year and presented detailed preliminary safety data at the 2022 Multidisciplinary Head and Neck Cancers Symposium.
Abstract Number: 6041
Abstract Title: PDS0101 a novel type 1 interferon and CD8+ T-cell activating immunotherapy in combination with pembrolizumab in subjects with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC)
Presenting Author: Jared Weiss, M.D., Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, who serves as the Lead Principal Investigator for VERSATILE-002
Session Title: Head and Neck Cancer
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
Abstract # 2518 poster discussion presentation summarizes findings from the ongoing National Cancer Institute (NCI)-led Phase 2 clinical trial, which studies PDS0101 in combination with two investigational immune-modulating agents. This news follows the achievement of the enrollment objective of 30 patients in the CPI refractory arm announced in March. The NCI will continue to enroll both CPI refractory and naive patients until the 56-patient enrollment objective is achieved.
Confidential
Abstract Number: 2518
Abstract Title: 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 AM-11:00 AM; 11:30 AM-1:00 PM CDT
For patients interested in enrolling in the NCI-led clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email [email protected], and/or visit the website: View Source
The abstracts will be available on Thursday, May 26, 2022 at 5:00 PM EDT on ASCO (Free ASCO Whitepaper).org.
"We are excited about the opportunity to provide updates on two of our PDS0101 clinical programs at this year’s ASCO (Free ASCO Whitepaper) annual meeting," commented Dr. Lauren V. Wood, M.D., 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 the 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.