PrimeVax Immuno-Oncology Receives IND Permission From FDA
SAN FRANCISCO, PRNewswire/ -- PrimeVax Immuno-Oncology, Inc. announced today that the company has successfully received their Investigational New Drug (IND) Application permission from the FDA to begin running their first human clinical trial.
"Our goal is simple: treat melanoma patients who have exhausted their options," states Tony Chen, PrimeVax's CEO. "It has been a long road, but we have not yet begun to fight. Opening this clinical trial is our first step to helping patients for whom current treatments have failed."
PrimeVax is pushing a novel therapeutic approach into clinic by combining virus-induced immune stimulation and dendritic cell therapy. A description of the PrimeVax approach was published in the peer-reviewed literature by the company1.
"I'm excited to see this progress," said Lisa Butterfield, PhD, Professor of Medicine, Surgery and Immunology at the University of Pittsburgh. "My immune monitoring lab performed preclinical experiments for PrimeVax a few years ago which were intriguing. I'm really interested to see how their novel therapy fares in patients, and look forward to seeing the PrimeVax story evolve as they tackle other tumor types after melanoma as well."
For this clinical trial, PrimeVax intends to treat metastatic melanoma patients after standard of care has failed. Once PrimeVax establishes good safety and tolerability, they will then target other cancers such as glioblastoma and triple negative breast.
PrimeVax is currently preparing their trial sites. Once opened, they will actively recruit patients.
PrimeVax Immuno-Oncology, Inc. is focused on the development of personalized immunotherapy by leveraging its PV-001 platform. The platform's goal is to enable a 1-time 1-week cancer treatment schedule for many cancer types agnostic of tumor mutation characteristics. PV-001 leverages the body's innate and adaptive immune responses simultaneously to trigger activation of T cells, NK cells, and other immunotherapeutic effects. The Company was founded in 2015 and will engage in human clinical trials in 2019. Initial indications to be targeted are metastatic melanoma, triple negative breast cancer, and glioblastoma.
SOURCE PrimeVax Immuno-Oncology, Inc.