GENOCEA BIOSCIENCES PROVIDES CLINICAL UPDATE

On July 20, 2020 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported updates to its clinical programs, the neoantigen vaccine GEN-009 and the neoantigen cell therapy, GEN-011 (Press release, Genocea Biosciences, JUL 20, 2020, View Source [SID1234562111]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

GEN-009
On July 30, 2020, the Company will share initial clinical data on the first 5 patients from Part B of the ongoing Phase 1/2a clinical trial exploring the combination of GEN-009 and immune checkpoint inhibitor-based regimens in advanced solid tumors. The lead investigator, Dr. Maura L. Gillison, MD, PhD, Professor of Medicine, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, will present.

GEN-011
In June 2020, the Company submitted the IND to support the initiation of a Phase 1/2 clinical trial and the 30-day FDA review period has just ended. The Company has received verbal notification from the U.S. Food and Drug Administration (FDA) that the agency has completed its review of the Company’s Investigational New Drug Application (IND) for GEN-011. In this verbal feedback, the FDA informed Genocea that it is placing the IND on clinical hold until it receives additional information pertaining to certain third-party reagents used in the GEN-011 manufacturing process. These reagents are not a component of the final cell therapy product. The Company expects to receive official written communication from the FDA regarding the hold and the FDA’s position in the near future and will work with the FDA to resolve their questions as quickly as possible.