Precision Gets IND OK To Advance New Cancer Therapy
Precision Biosciences has done it again.
The Durham clinical-stage biotechnology company has received a U.S. Food and Drug Administration go-ahead to advance clinical testing of its new drug for patients with relapsed/refractory non-Hodgkin Lymphoma.
The FDA has accepted Precision’s Investigational New Drug application for PBCAR19B, which has demonstrated that it can delay both T cell and natural killer-cell-driven allogeneic rejection in preclinical studies, according to Precision. This is the fourth IND Precision has received for its genome-edited CAR T therapies in the past couple of years.
The company plans to begin a phase 1 study to evaluate PBCAR19B’s safety and clinical activity and to identify the maximum tolerated dose of the drug.
“We believe that the ability to reduce rejection by both cell types holds potential for improved persistence of allogeneic CAR T cells and that, by bringing PBCAR19B into the clinic while continuing to develop our lead allogeneic candidate PBCAR0191, we have two opportunities to achieve our goal of producing deep and durable clinical responses,” said Precision CEO Matt Kane.
PBCAR19B is a stealth cell therapy to treat patients who have CD19-positive malignancies. It’s designed to prevent the rejection of both T cells and natural killer cells (which can eliminate tumor cells) after drug infusion.
Precision is partnering with Servier – an international pharmaceutical company based in Suresnes, France, that is governed by a non-profit foundation – to advance the therapy. Servier has the exclusive rights to opt in for late-stage development and commercialization of PBCAR19B.
Precision can participate in the development and commercialization of any licensed products that result from the collaboration through a 50/50 co-development and co-promotion option.
Precision’s New Approach to Fighting Cancer
Precision’s technology is part of a new approach to fighting cancer using T cells -- a type of immune system cell that recognizes invading germs or cancer cells. T cells are engineered to carry a cancer bullet called a tumor-targeting chimeric antigen receptor (CAR). These cells can potentially save the lives of patients who are unresponsive to traditional chemotherapy and radiation.
Autologous CAR T therapies currently on the market rely on patient-derived T cells extracted and individually manufactured for each patient using that patient’s own cells – a complex and lengthy process.
Precision’s allogeneic CAR T candidates use T cells derived from donors. The T cells are manufactured in large batches and are cryopreserved (intact at extremely low temperatures) for shipment, storage and off-the-shelf use.
These allogeneic CAR T product candidates rely on Precision’s ARCUS genome-editing platform to remove the T cell receptor to prevent graft versus host disease and eliminate the need for donor-patient matching. ARCUS editing also enables targeted insertion of the CAR gene into a single, specific location in the T cell genome for more controlled, consistent expression.
Precision Biosciences is a 2006 Duke University spinout dedicated to improving life by using its ARCUS gene editing technology to treat diseases and create healthy and sustainable food and agricultural solutions.
In 2018 the company created a new name and brand identity for its food and agriculture business, Elo Life Systems. That business uses Precision’s ARCUS platform and other new technologies to improve the health of people and the planet by supporting resilient and sustainable food production systems.