Precision BioSciences and Servier Expand CAR T Oncology Development Collaboration with Four New Programs Targeting Hematological and Solid Tumors

DURHAM, NC, USA and PARIS, France I September 17, 2020 I Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS® genome editing platform, in collaboration with Servier, an independent global pharmaceutical company, today announced the companies have added two additional hematological cancer targets beyond CD19 and two solid tumor targets to its CAR T development and commercial license agreement.

“The addition of these new targets will build on the productive multi-year collaboration between Precision and Servier that is driving the development of PBCAR0191, our lead allogeneic CAR T candidate targeting CD19,” said Matt Kane, CEO and Co-Founder of Precision BioSciences. “We are pleased to expand our collaboration with Servier and apply our proprietary single-step cell engineering and unique allogeneic CAR T manufacturing and development strategies to potentially extend the reach of 'off-the-shelf' CAR T therapies beyond hematological cancers and into solid tumors.”

Under the terms of the existing development and commercial license agreement between Servier and Precision, Servier has selected two hematological and two solid tumor targets beyond those already in Precision’s allogeneic CAR T pipeline. Precision intends to leverage its proprietary ARCUS genome editing platform and CAR T development and manufacturing expertise for early-stage research and development activities, including Investigational New Drug (IND) filing through the manufacturing of initial clinical trial material for a Phase 2 study. Servier has the right to opt in for late-stage development and commercialization, and Precision has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the United States. With the addition of these new targets, Precision expects to receive milestone payments in 2020 and 2021. Precision is also eligible for option fees, clinical, regulatory, and sales milestones in addition to royalties on product sales.

“At Servier, we partner for a purpose – our patients. We are pleased to add four additional targets beyond CD19 to our collaboration with Precision BioSciences as part of our commitment to oncology,” said Patrick Therasse, Deputy Head of global RD oncology at Servier. “We look forward to utilizing their ARCUS genome editing platform with these new targets to potentially develop several innovative allogeneic CAR T therapies for patients with a range of solid and hematological malignancies.”

About PBCAR0191
PBCAR0191 is an investigational allogeneic chimeric antigen receptor (CAR T) candidate targeting CD19 in a Phase 1/2a multicenter, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study for the treatment of patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). The NHL cohort includes patients with mantle cell lymphoma (MCL), an aggressive subtype of NHL, for which Precision has received both Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration (FDA). More information about the study is available at www.clinicaltrials.gov, study identifier number NCT03666000.

About Precision’s Allogeneic CAR T Platform
Precision is advancing a pipeline of cell-phenotype optimized allogeneic CAR T therapies, leveraging fully scaled, proprietary manufacturing processes. The platform is designed to maximize the number of patients who can potentially benefit from CAR T therapy. Precision carefully selects high-quality T cells derived from healthy donors as starting material, then utilizes its unique ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR, creating a consistent product that can be reliably and rapidly manufactured that is designed to prevent graft-versus-host disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of naïve and central memory CAR T cells throughout the manufacturing process and in the final product.

About Precision BioSciences, Inc.
Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Company’s pipeline consists of multiple “off-the-shelf” CAR T immunotherapy clinical candidates and several in vivo gene correction therapy candidates to potentially cure genetic and infectious diseases where no known adequate treatments exist. More information about Precision BioSciences is available at www.precisionbiosciences.com.

About Servier
Servier is a Global pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 149 countries and a total revenue of 4.6 billion euros in 2019, Servier employs 22,000 people worldwide. Entirely independent, the Group invests on average 25% of its total revenue (excluding generics) every year in research and development and uses all its profits for its development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory, and neurodegenerative diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development. More information is available at www.servier.com.

SOURCE: Precision BioSciences

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