April 14, 2020
Grid Therapeutics Announces FDA Approval of IND Application for GT103
Grid Therapeutics, LLC, a biotechnology company developing a first-in-class, novel human-derived targeted immunotherapy for cancer, today announced that the U.S. Food and Drug Administration approved its investigational new drug (IND) application for GT103, Grid’s lead therapeutic candidate for the treatment of solid tumors.
Under this IND, the Company is now poised to initiate a Phase 1 clinical trial in patients with refractory non-small cell lung cancer. Expected to begin in the second quarter of 2020, the clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of GT103. The study shall begin at Duke University Health System, where startup activities are currently underway. Additional sites will be added once the initial site is up and recruiting patients.
“The FDA’s IND clearance for GT103 marks a critical milestone for Grid Therapeutics as we evaluate this first in class therapeutic in the clinic,“ said Dr. Edward Patz, Jr., CEO of Grid. “We believe GT103 has the potential to improve clinical responses in lung cancer patients, including those who are refractory to currently approved immunotherapies. As the only company developing human-derived antibodies from single B cells against novel targets, we hold a differentiated and important position in the immuno-oncology space.”
Grid Therapeutics is a clinical stage biotech company built on the innovative science developed by Edward F. Patz, Jr. MD and his team of scientists at Duke University Medical Center. Located in Durham, North Carolina, Grid is currently using its unique platform to develop a pipeline of human derived, tumor-targeted antibodies for the treatment of a variety of cancers.
[Originally posted by OA Online — Apr 14, 2020]