April 8, 2020

Share Medicine Clinical Trials Start-ups

Precision BioSciences Announces Dosing of First Patient in Phase 1/2a Clinical Trial of PBCAR20A


Precision BioSciences, Inc. (DTIL), a life sciences company dedicated to improving life through the application of its pioneering, proprietary ARCUS® genome editing platform, today announced the initiation of patient dosing in a Phase 1/2a clinical trial of its second off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR20A.

Wholly owned by Precision, PBCAR20A is an investigational allogeneic anti-CD20 CAR T therapy in development for the treatment of two separate cohorts of patients. The first cohort will enroll patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL), and the second will include patients with R/R chronic lymphocytic leukemia (CLL) or R/R small lymphocytic lymphoma (SLL). The NHL cohort will include patients with mantle cell lymphoma (MCL), an aggressive subtype of NHL, for which Precision BioSciences has received orphan drug designation from the United States Food and Drug Administration (FDA).

“As we navigate the unprecedented COVID-19 pandemic, we are incredibly grateful to patients and their families, investigators and their clinical study sites, and our employees and partners for advancing a study that has the potential to treat very challenging and life threatening cancers,” commented Matt Kane, CEO and co-founder of Precision BioSciences. “It is very encouraging that, based on the safety profile we have so far observed with our first CAR T candidate, PBCAR0191, the FDA authorized us to begin dosing PBCAR20A at what was expected to be our second dose level. It is a testament to the progress we have made over the past year that Precision now has two CAR T programs in clinical trials.”

“We believe that PBCAR20A provides the opportunity to apply our ARCUS technology and cell engineering platform to target CD20, a validated antigen in NHL and CLL/SLL, which often remains expressed in patients previously treated with CD19-targeted therapies. This approach may allow us to address some patients who failed CD19 CAR T treatment and/or consider earlier line treatment to achieve meaningful clinical benefit in patients suffering with these diseases,” noted Chris Heery, MD, Chief Medical Officer of Precision BioSciences. “Additionally, receiving orphan drug designation from the FDA for MCL provides a special opportunity to serve a group of patients who have a poor prognosis with currently available treatments.”

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[Originally posted by Yahoo Finance — April 7, 2020]