|
|
Biotech
|
|
||
DTIL - 3Q UpdateDURHAM, N.C., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Precision
BioSciences, Inc. (Nasdaq: DTIL) (“Precision”), a genome editing company
dedicated to improving life through the application of its pioneering,
proprietary ARCUS® platform, today announced financial results for the
third quarter ended September 30, 2019 and provided a corporate update. Key Highlights
*After quarter end, announced publication of an abstract accepted for
presentation at the upcoming 61st Annual Meeting of the American Society
of Hematology (ASH) in Orlando, Florida, December 7-10, 2019,
supporting the safety and clinical activity of Precision BioSciences’s
lead CD19-targeted off-the-shelf (allogeneic) chimeric antigen receptor
(CAR) T product candidate, PBCAR0191. Abstract reports initial data from
first three patients treated at Dose Level 1 as of August 1, 2019.
Trial is ongoing and updated data, including from patients treated at
Dose Level 2, will be presented during the ASH annual meeting on
December 9, 2019 at 6:00 pm ET. * Announced
an investigator update event during ASH meeting to discuss the PBCAR0191
data presented, starting at 8:15pm ET on December 9, 2019, with
accompanying live webcast. *Received
acceptance from US Food and Drug Administration (FDA) of investigational
new drug (IND) application for second and wholly-owned allogeneic CAR T
therapy candidate PBCAR20A, targeting CD20. Phase 1/2a clinical trial
to begin in the fourth quarter of 2019. *
Further enhanced senior leadership team with appointment of David
Thomson, PhD, as Chief Operating Officer, and Nicholas Riddle, MD, PhD,
as Vice President, Financial Strategy and Investor Relations. “We reached a transformative moment for Precision BioSciences this quarter; it is very exciting to report initial data from our first clinical trial with a product candidate that leverages our unique approach to allogeneic CAR T therapy,” commented Matt Kane, Chief Executive Officer and Co-Founder of Precision BioSciences. “These data bring the reality of a true off-the-shelf CAR T therapy a step closer for patients in need of new and improved treatment options. While preliminary and from a limited number of patients, the safety profile, in vivo cell expansion and early evidence of clinical activity we have demonstrated with PBCAR0191 in the absence of biologic lymphodepletion is very encouraging and gives us confidence in the approach we have taken to allogeneic CAR T. We are looking forward to sharing updated results from patients treated at both Dose Level 1 and Dose Level 2 at ASH. The team at Precision is committed to advancing our pipeline of differentiated CAR T product candidates as rapidly as possible to bring these potentially transformative therapies to patients.” Recent Developments and Upcoming Milestones Program updates On November 6, 2019, Precision announced that initial results from the ongoing Phase 1/2a trial of its lead investigational allogeneic CAR T cell therapy candidate, PBCAR0191, will be presented during the 61st Annual Meeting of the American Society of Hematology in Orlando, Florida, December 7-10, 2019. PBCAR0191, which is being developed in collaboration with Servier, is Precision’s first allogeneic CAR T therapy candidate in clinical trials and targets the well characterized cancer cell surface protein CD19. The Phase 1/2a trial includes adult patients with relapsed or refractory (R/R) non-Hodgkin’s lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). The abstract outlining initial data from patients treated with PBCAR0191 at Dose Level 1 can be accessed on the ASH conference website. Data in the abstract include results as of the cutoff date of August 1, 2019 for three patients with advanced NHL treated at Dose Level 1. No significant toxicities were observed, including no serious adverse events and no dose-limiting toxicities. All patients had a minimum follow-up of 28 days (median 60 days). Two of the three patients experienced an objective tumor response by Lugano criteria, at day 14 and day 28, respectively. The third patient, who had previously progressed following treatment with axicabtagene ciloleucel (Yescarta®), an approved anti-CD19 autologous CAR T therapy, had not met the definition of response, but demonstrated evidence of central necrosis, decreased tumor size, and decreased PET-avidity at day 28, in the context of post-infusion tumor site pain and mild CRS symptoms. Peripheral blood analysis for CAR T cell expansion has identified preliminary evidence of cell expansion. The PBCAR0191 Phase 1/2a trial is ongoing and updated results from patients treated at Dose Level 1 and Dose Level 2 will be presented at the ASH annual meeting on December 9, 2019 starting at 6:00 p.m. ET. Precision will host a live webcast of an investigator update event during the ASH meeting to discuss the presented data, beginning at 8:15 p.m. ET on December 9, 2019. The webcast will be accessible from the "Events & Presentations" page within the Investors & Media section of the Precision website and a replay will be available for 30 days following the call. On September 16, 2019, Precision announced that the FDA accepted its IND application for PBCAR20A. Wholly-owned by Precision, PBCAR20A is an allogeneic anti-CD20 CAR T therapy candidate in development for the treatment of patients with NHL, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL). Precision plans to initiate a Phase 1/2a clinical trial in the fourth quarter of 2019, with initial data expected in 2020. Senior leadership appointments On September 30, 2019, Precision announced that Nicholas Riddle, MD, PhD, joined as Vice President, Financial Strategy and Investor Relations. Dr. Riddle joined Precision from J.P. Morgan where he was an Executive Director in the global healthcare investment banking group. On September 23, 2019, Precision appointed David Thomson, PhD, to the position of Chief Operating Officer. Dr. Thomson previously served as Precision’s Chief Development Officer since 2017. Upcoming Corporate Presentations Precision’s senior management team will be presenting and meeting with investors at the following upcoming conferences: Barclays Gene Editing and Gene Therapy Summit, New York, NY, November 13, 2019 Stifel Healthcare Conference, New York, NY, November 20, 2019 Jefferies London Healthcare Conference, London, UK, November 20, 2019 Piper Jaffray Annual Health Care Conference, New York, NY, December 3–5, 2019 J.P. Morgan Healthcare Conference, San Francisco, CA, January 13-16, 2020 |
return to message board, top of board |