Initial Phase 1 Results from the ALLO-501 ALPHA Trial at ASCO Demonstrated an Overall Response Rate of 75% and Complete Response Rate of 44% in CAR T Naïve Relapsed/Refractory Non-Hodgkin Lymphoma Patients
In the ALPHA Trial, Higher Dose ALLO-647 was Associated with Deeper Lymphodepletion, Delayed Host T Cell Recovery and a Higher Complete Response RateInitiated Phase 1 Portion of ALPHA2 Trial for ALLO-501A, a Next-Generation anti-CD19 AlloCAR T™ Intended for Phase 2 DevelopmentCompleted Initial Dose Escalation Portion of the Phase 1 ALLO-715 UNIVERSAL Trial in Relapsed/Refractory Multiple Myeloma with Data Expected in Q4 2020Investigational New Drug (IND) Application to Evaluate ALLO-316, an anti-CD70 AlloCAR T in Renal Cell Carcinoma Expected by Year EndcGMP Production in Newark Manufacturing Facility On Track for 2021Ended Second Quarter with $1.1 Billion in Cash, Cash Equivalents and InvestmentsConference Call and Webcast Scheduled for 5:30 AM PT/8:30 AM ETSOUTH SAN FRANCISCO, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today provided a corporate update and reported financial results for the quarter ended June 30, 2020. “We are incredibly pleased with the progress we’ve made across our AlloCAR T platform, which now includes ongoing clinical trials for ALLO-501, ALLO-501A and ALLO-715,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “The ALLO-501 data we presented at ASCO in May solidifies our belief in the potential of AlloCAR T therapy in hematologic malignancies. We look forward to presenting initial data in a second hematologic malignancy, multiple myeloma, later this year as we advance the same innovative approach to solid tumors in 2021.”Recent HighlightsAnti-CD19 AlloCAR T Program
Initial data from ALLO-501’s ALPHA trial provided support for the Company’s approach to AlloCAR T therapy. Allogene intends to leverage ALLO-501 to optimize trial design and dose selection as it prepares for a potentially pivotal Phase 2 trial of ALLO-501A in 2021.ALLO-501 ALPHA Phase 1 Trial
In May 2020 at the American Society of Clinical Oncology (ASCO) annual meeting, the Company presented initial data from its dose escalation Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL). This study utilizes ALLO-647, the Company’s anti-CD52 monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen. The next readout from this trial is expected to be in late 2020 or early 2021. As per the ASCO presentation, 22 patients were evaluable for safety and 19 patients were evaluable for efficacy with at least one tumor assessment as of the May 2020 data cutoff.Responses were observed across all cell doses and NHL histologies (diffuse large B-cell lymphoma and follicular lymphoma).Across all evaluable patients, there were seven complete responses (CR) and five partial responses (PR) for an overall response rate (ORR) of 63% and CR rate of 37%.In CAR T naïve patients (n=16) the ORR was 75% and the CR rate 44%.Higher dose ALLO-647 was associated with a higher CR rate.With a median follow-up of 3.8 months, nine of the 12 responding patients (75%) remained in response as of the data cutoff on May 11, 2020.No dose limiting toxicities, graft-vs-host disease, or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was observed. Cytokine release syndrome occurred in 32% of the patients, was mainly mild to moderate in severity and manageable with standard recommendations. Four patients (18%) experienced serious adverse events (SAE), all of which resolved.ALLO-501A ALPHA2 Phase 1 Trial
ALLO-501A is a next generation anti-CD19 AlloCAR T intended for Phase 2 development. During the second quarter, the Company initiated enrollment in the Phase 1 portion of the ALPHA2 trial. This abbreviated dose escalation study is a single-arm, open-label, multicenter trial of ALLO-501A in patients with R/R large B-cell lymphoma. The Company expects to begin the Phase 2 portion of this study in 2021.Anti-BCMA AlloCAR T Program
The Company continues to progress its robust anti-BCMA strategy centered around ALLO-715 for the treatment of multiple myeloma (MM).ALLO-715 UNIVERSAL Phase 1 Trial
– The ALLO-715 Phase 1 UNIVERSAL trial in patients with relapsed/refractory MM utilizes ALLO-647 as part of the lymphodepletion platform. The initial dose escalation portion of the UNIVERSAL trial using 39mg of ALLO-647 is now complete. The trial continues to enroll patients with initial data anticipated in Q4 2020.
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