Precision BioSciences to Present Data from its First Generation CD19 Allogeneic CAR T Program in Relapsed/Refractory Non-Hodgkin Lymphoma at the 2021 American Society of Clinical Oncology Meeting

Rhea-AI Summary

Precision BioSciences (Nasdaq: DTIL) announced additional data from its Phase 1/2a study of PBCAR0191, an allogeneic CAR T candidate targeting CD19. The data will be presented at the 2021 ASCO Meeting, June 4-8. The study included 13 patients with relapsed/refractory non-Hodgkin lymphoma, showing 77% had aggressive forms. Results highlighted an acceptable safety profile, with no severe adverse effects reported. The company is also progressing towards the clinical start of PBCAR19B, aimed at enhancing CAR T persistence. A conference call on data review is scheduled for June 4, 2021, at 8:00 a.m. ET.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies, today announced that additional data from its Phase 1/2a study of PBCAR0191, the Company’s first generation, off-the-shelf allogeneic CAR T candidate targeting CD19 will be presented at the 2021 American Society of Clinical Oncology (ASCO) Meeting being held virtually June 4-8, 2021.

Abstracts are available and can be viewed on the ASCO web site at www.asco.org. Additional data including updated response rates, safety, and durability will be presented at the ASCO meeting.

Title: Preliminary safety and efficacy of PBCAR0191, an allogeneic, off-the-shelf CD19-targeting CAR T product, in relapsed/refractory (r/r) CD19+ NHL
Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia, Abstract 7516
Date/Time: Friday, June 4, 2021 at 9:00 a.m. ET
Presenting Author: Bijal Shah, M.D., Moffitt Cancer Center

By February 1, 2021, 13 patients with R/R non-Hodgkin lymphoma (NHL) met study eligibility criteria and had received PBCAR0191 dose level 3 at 3x10⁶ or equivalent with either standard lymphodepletion (sLD) (n=6)¹ or enhanced lymphodepletion (eLD) (n=7)². Of these patients, 77% had aggressive lymphomas and 62% had four or more courses of prior treatment. PBCAR0191 continued to demonstrate an acceptable safety profile with no cases of graft versus host disease, no cases of Grade ≥ 3 cytokine release syndrome, and no cases of Grade ≥ 3 immune effector cell-associated neurotoxicity syndrome.

“These results continue to confirm the activity of PBCAR0191 with strategies that mitigate rejection, and we look forward to sharing additional data in the poster and on our hosted conference call on June 4,” said Alan List, M.D., Chief Medical Officer at Precision BioSciences. “While we continue to advance PBCAR0191 through its Phase 1/2a study, we eagerly await the clinical start of our next-generation, immune evading stealth cell technology with PBCAR19B, which includes modifications designed to enhance CAR T persistence and delay allogeneic immune rejection by T cells and natural killer cells.”

Company-Hosted Conference Call and Web Cast Information
Precision will host a conference call and webcast on Friday, June 4, 2021 at 8:00 a.m. ET to review the most recent interim clinical data for PBCAR0191. The dial-in conference call numbers for domestic and international callers are (866) 996-7202 and (270) 215-9609, respectively. The conference ID number for the call is 5647916. Participants may access the live webcast and the accompanying presentation materials on Precision’s website www.precisionbiosciences.com in the Investors and Media section under Events and Presentations. An archived replay of the webcast will be available on Precision’s website.

About Precision BioSciences, Inc.
Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its wholly 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 cure genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our clinical development pipeline and interim data announcements. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “believe,” “could,” “eligible,” �

FAQ

What is the significance of the data for PBCAR0191 presented at ASCO 2021?

The data from the Phase 1/2a study of PBCAR0191 shows promising efficacy and an acceptable safety profile in patients with relapsed/refractory non-Hodgkin lymphoma.

When will the conference call about PBCAR0191's interim data take place?

The conference call will be held on June 4, 2021, at 8:00 a.m. ET.

What were the results reported for patients treated with PBCAR0191?

In the study, 77% of patients had aggressive lymphomas, and the treatment showed no severe adverse effects.

What future developments did Precision BioSciences mention regarding CAR T therapies?

Precision BioSciences plans to initiate clinical trials for PBCAR19B, a next-generation CAR T therapy aimed at improving persistence and reducing immune rejection.

Where can I find more information about the ASCO presentation for PBCAR0191?

More details can be accessed on the ASCO website and during the company’s conference call.