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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 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.
Allogene Therapeutics (Nasdaq: ALLO) will present its advancements on the AlloCAR T™ platform during a virtual CD19 Forum on May 19, 2021, at 2:30 PM PT/5:30 PM ET. The discussion will cover Phase 1 trial results of ALLO-501 and ALLO-501A for relapsed/refractory non-Hodgkin lymphoma, in collaboration with Servier. The company will also share data on ALLO-647's safety and pharmacokinetics. Presenters include executives from Allogene and external experts from notable cancer research institutions. Poster presentations will be featured at the ASCO Annual Meeting in June.
Allogene Therapeutics (ALLO) reported a net loss of $33 million for Q1 2021, translating to $0.25 per share. With $964 million in cash and investments, the company is positioned for growth. Key clinical updates include the ALLO-501 and ALLO-501A studies to be presented at ASCO, while ALLO-715 received RMAT designation for multiple myeloma treatment. ALLO-605's IND application was cleared by the FDA, and the TRAVERSE trial for ALLO-316 is now underway. The company anticipates full-year operating expenses between $300 million and $330 million.
Allogene Therapeutics (Nasdaq: ALLO) announced the presentation of longer-term data from its Phase 1 ALPHA study on ALLO-501 in relapsed/refractory non-Hodgkin lymphoma, alongside initial findings from the Phase 1 ALLO-501A ALPHA2 study. This presentation will take place during the virtual 2021 ASCO Annual Meeting from June 4-9, 2021. ALLO-501A aims for a pivotal Phase 2 trial and has received FDA Fast Track Designation for DLBCL. Additionally, safety data for ALLO-647 will be presented, further advancing Allogene's AlloCAR T™ platform in cancer treatment.
Allogene Therapeutics is set to release its first quarter 2021 financial results on May 5, 2021, after market close. Following this, a live audio webcast and conference call will take place at 2:00 PM PT (5:00 PM ET). The company specializes in developing allogeneic CAR T therapies for cancer, aiming to provide scalable, accessible treatments. The webcast will be available on their website, www.allogene.com, with a replay option for 30 days. The release includes cautionary forward-looking statements regarding company projections and financial reporting.
Allogene Therapeutics, Inc. (Nasdaq: ALLO) announced that the FDA granted RMAT designation for ALLO-715, a treatment for relapsed/refractory multiple myeloma. This designation is based on initial clinical data from the UNIVERSAL trial, which showed that ALLO-715 can achieve significant clinical responses without the need for bridging therapy or manufacturing delays. The RMAT designation aims to expedite the development of promising therapies addressing unmet medical needs. Allogene aims to complete the UNIVERSAL study and work closely with the FDA for further advancement.
Allogene Therapeutics announced FDA clearance for an IND application to study ALLO-605 targeting relapsed/refractory multiple myeloma. This marks the initiation of the Phase I IGNITE trial, expected to start in mid-2021, which will assess escalating doses of ALLO-605. This therapy incorporates the proprietary TurboCAR technology designed to enhance T cell function and potency. ALLO-605 is part of a broader strategy targeting BCMA in treating multiple myeloma, complementing ongoing trials with other candidates including ALLO-715 and ALLO-647.
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