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VLP Therapeutics initiates Phase 1 clinical trial of cancer treatment with Stanford Medicine: opening the door to tumor immunotherapy with VRP technology

By August 28, 2025No Comments

VLP Therapeutics, Inc. (VLPT), Maryland, US-based biotech company, announced on August 27 the initiation of a Phase 1 clinical trial of VLPONC-01, a new cancer immunotherapy, in collaboration with Stanford Medicine. The trial (NCT06736379) is being conducted at Stanford Health Care with the primary objectives of assessing the safety of cancer immunotherapy and identifying the appropriate dosage range for this novel immunotherapy.

VLPONC-01 utilizes VLPT’s proprietary virus replicon particle (VRP) technology — an innovative platform combining virus-like particle (VLP) and replicon technologies — to activate targeted immune responses within the tumor microenvironment.

“As a head and neck surgeon, I am excited to lead this trial, which is based on new immunotherapy research from VLP Therapeutics,” said Fred M Baik, MD, Lead PI for the study and Assistant Professor of Otolaryngology – Head & Neck Surgery at Stanford Medicine. “Our team is committed to advancing treatment for the estimated 70,000 new HNC patients annually in the US alone and 900,000 worldwide.”

“There is a critical need for faster and more effective immunotherapy strategies that harness emerging immune targets in head and neck cancer,” said Quynh-Thu Le, MD, co-head of the study and Katharine Dexter McCormick & Stanley McCormick Memorial Professor and Chair of the Department of Radiation Oncology at Stanford Medicine. “I believe that this trial with VLP Therapeutics is one with such an approach, using VRPs’ ability to impact the tumor microenvironment and induce measurable biological changes.”

“The launch of this clinical trial is a key milestone that highlights the progress we’ve made in pioneering cancer immunotherapies” said Wataru Akahata, PhD, founder and CEO of VLPT. “We are honored to work with Drs. Baik and Le—renowned experts in their fields. This study represents a major step forward in our mission to deliver innovative therapies to patients with urgent medical needs and provide therapeutic options for patients battling cancer.”

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About VLP Therapeutics: VLP Therapeutics, Inc. (VLPT), co-founded in 2013 by Drs. Wataru Akahata, Ryuji Ueno, and Sachiko Kuno, is a Maryland, US-based biotech company with a mission to address unmet medical needs worldwide and expand the frontiers of prophylactic and therapeutic immunotherapy. VLPT is currently engaged in research and development of cancer treatment as well as infectious disease prevention.

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