On June 24, 2020 Grid Therapeutics, LLC, a clinical stage biotechnology company developing a first-in-class, novel, human-derived targeted immunotherapy for solid tumors, reported that the first patient has been dosed in a Phase 1/2 study of GT103 in patients with refractory NSCLC (Press release, Grid Therapeutics, JUN 24, 2020, View Source [SID1234561447]). The study is initially being conducted at the Duke University Medical Center.
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"Today’s announcement marks the first time a therapeutic antibody derived from single B cells of cancer patients, and the first IgG3 subclass, has advanced to the clinic," said Dr. Edward Patz Jr., M.D., Chief Executive Officer of Grid, and the James and Alice Chen Professor of Radiology, Professor in Pharmacology and Cancer Biology at Duke University School of Medicine. "Initiation of this study is a significant milestone for Grid, as we believe our unique strategy will transform cancer therapy."
The Phase 1 segment of this trial will generate important data about the safety and tolerability of GT103, which targets complement factor H, a protein that protects tumor cells from complement lysis. The Phase 2 segment will be performed in combination with a checkpoint inhibitor, as recent pre-clinical data shows GT103 modulates the adaptive immune response and may potentiate current immune-oncology therapy.
Paolo Paoletti, Grid Board member and Chief Executive Officer of GammaDelta Therapeutics, stated, "This is an exciting and pioneering approach to a highly prevalent and intractable cancer, which currently has a very poor prognosis despite best available treatments."
This trial is also designed to validate Grid’s innovative platform for the rapid development of additional therapeutic antibodies for the treatment of multiple forms of cancer.
About the Study
The Phase 1 open-label, dose-escalation clinical trial of GT103 is designed to assess the safety and tolerability of GT103 as a single agent. The study will enroll subjects with refractory NSCLC. Key objectives in the study include determining the recommended Phase 2 dose, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity. An expansion cohort and combination study with checkpoint inhibitors is planned to rapidly follow. Please refer to www.clinialtrials.gov for additional clinical trial details.