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Allogene Therapeutics, Inc. (Nasdaq: ALLO) is a clinical-stage biotechnology company focused on the development and commercialization of allogeneic chimeric antigen receptor T-cell (AlloCAR T™) therapies for cancer and autoimmune diseases. Leveraging the expertise of former Kite Pharma executives, Allogene aims to revolutionize cancer treatment with innovative off-the-shelf CAR T solutions. These therapies, derived from healthy donor cells, provide a scalable and readily available option, eliminating the lengthy and complex process of personalized cell therapy.
The company's portfolio includes 16 pre-clinical T cell therapy assets and UCART19, an allogeneic CAR T therapy in phase 1 development for acute lymphoblastic leukemia (ALL). Notable core programs target various malignancies such as lymphoma, leukemia, solid tumors, and autoimmune diseases. Among its leading investigational products is cemacabtagene ansegedleucel (cema-cel), currently undergoing pivotal phase 2 ALPHA3 trials for large B-cell lymphoma (LBCL) and phase 1 trials for relapsed/refractory chronic lymphocytic leukemia (CLL). ALLO-316, aimed at renal cell carcinoma (RCC), and ALLO-329, targeting autoimmune diseases with Dagger® technology, further strengthen Allogene's robust pipeline.
Allogene collaborates with leading biotech firms like Foresight Diagnostics and Arbor Biotechnologies to enhance its clinical development capabilities. Recent achievements include strategic partnerships and a $15 million grant from the California Institute for Regenerative Medicine (CIRM) supporting the development of ALLO-316. Financially, Allogene reported a strong cash runway extending into 2026, with latest funding rounds ensuring continued support for its R&D initiatives.
Stay informed on Allogene's progress as it drives the future of allogeneic CAR T therapy, providing broader patient access and more efficient cancer treatment options.
Allogene Therapeutics announced that the FDA granted orphan-drug designation (ODD) to its ALLO-715 therapy for multiple myeloma. This follows the previous Regenerative Medicine Advanced Therapy (RMAT) designation received in April 2021. The Phase 1 UNIVERSAL trial showed ALLO-715 can achieve clinical responses without the need for bridging therapy. The company plans to update on the trial by the end of 2021. With ODD, the therapy is entitled to various development incentives, including potential marketing exclusivity.
Allogene Therapeutics (ALLO) provided a significant update on its clinical pipeline and financials for Q2 2021. The company showcased promising data from its CD19 program, revealing a 75% overall response rate and 50% complete response rate in CAR T naïve patients with relapsed/refractory non-Hodgkin lymphoma. Financially, Allogene ended the quarter with $913 million in cash. Despite a net loss of $70.9 million, the company remains focused on pivotal trials for ALLO-501A and the development of new therapies, including ALLO-605, which received FDA Fast Track designation.
Allogene Therapeutics has appointed Elizabeth Barrett and Vicki Sato, Ph.D., to its Board of Directors, enhancing its leadership as it prepares for the industry's first pivotal trial of allogeneic CAR T therapy. Barrett, a veteran in oncology commercialization, previously led UroGen Pharma and Novartis Oncology, managing key CAR T launches. Dr. Sato brings her extensive experience from Vertex Pharmaceuticals and Biogen, focusing on unlocking the potential of cell therapy. Their expertise aims to bolster Allogene's efforts to deliver on-demand, off-the-shelf CAR T therapies.
Allogene Therapeutics (Nasdaq: ALLO) will announce its second quarter 2021 financial results on August 4, 2021, post-market close. The company, which specializes in developing allogeneic CAR T therapies for cancer, plans to host a live audio webcast at 2:00 PM PT/5:00 PM ET to discuss these results. The event aims to provide insights into the company's progress and future plans in the rapidly evolving field of biotechnology. Interested parties can access the webcast via the company's website.
Allogene Therapeutics, a clinical-stage biotechnology company based in South San Francisco, announced its participation in two virtual investor conferences. The events include William Blair's Biotech Focus Conference on July 14, 2021, at 5:55 AM PT and Canaccord Genuity's 41st Annual Growth Conference on August 11, 2021, at 7:00 AM PT. Webcasts will be available on their website under the Investors tab, with replays accessible for 30 days thereafter. Allogene focuses on developing allogeneic CAR T therapies for cancer, aiming for accessible and reliable cell therapy solutions.
Allogene Therapeutics has initiated the Phase 1 IGNITE Dose Escalation Trial for ALLO-605, a next-generation AlloCAR T therapy targeting BCMA for relapsed or refractory multiple myeloma. The FDA granted Fast Track designation to ALLO-605, highlighting its potential to address unmet medical needs. ALLO-605 employs TurboCAR technology, which enhances AlloCAR T cell function, potentially making it effective against solid tumors and hematologic malignancies. Allogene is pursuing an aggressive strategy with multiple candidates to benefit patients suffering from multiple myeloma.
Allogene Overland Biopharm has appointed Shuyuan Yao, Ph.D., as its Chief Executive Officer, effective immediately. Dr. Yao brings over 15 years of experience in cell and gene therapy, previously serving as Chief Scientific Officer at WuXi Advanced Therapies. His leadership is expected to drive the joint venture's mission to commercialize AlloCAR T™ therapies in China and Asia-Pacific markets. Allogene Overland focuses on the development of specific AlloCAR candidates targeting cancer biomarkers like BCMA and CD70, aiming to expand its global footprint in innovative therapies.
Allogene Therapeutics presented data at the 2021 ASCO Annual Meeting on its anti-CD19 AlloCAR T therapies, highlighting results from the ALLO-501 and ALLO-501A trials. The six-month complete response (CR) rate for CAR T naive large B-cell lymphoma (LBCL) patients was reported at 36%, with an overall response rate (ORR) of 75%. Safety profiles showed no dose-limiting toxicities or significant graft-vs-host disease. A potentially pivotal trial for ALLO-501A is anticipated by late 2021, indicating further developments in Allogene's clinical pipeline.
Allogene Therapeutics (Nasdaq: ALLO), a clinical-stage biotechnology firm, announced participation in five virtual investor conferences this May and June 2021. Notable events include Cowen's 2nd Annual Virtual Oncology Innovation Summit on May 21, Jefferies Virtual Healthcare Conference on June 1, Goldman Sachs' Healthcare Conference on June 8, BofA Securities' Napa Biopharma Conference on June 15, and JMP Securities' Life Sciences Conference on June 16. Webcasts will be accessible on their website, where replays will also be available for 30 days.
The ALLO-501 ALPHA trial by Allogene Therapeutics has shown promising results in treating non-Hodgkin lymphoma, reporting a 75% overall response rate and a 50% complete response rate across various histologies in CAR T naïve patients. Notably, the longest ongoing complete response lasted 15 months. Consolidation dosing demonstrated early promise with no dose-limiting toxicities reported. The company aims to initiate a pivotal trial for ALLO-501A by late 2021. Safety profiles for ALLO-647 were found manageable, correlating with responses in clinical trials.
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