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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 (Nasdaq: ALLO) has activated three community cancer centers for its pivotal Phase 2 ALPHA3 trial of cemacabtagene ansegedleucel (cema-cel) for large B-cell lymphoma (LBCL). The trial aims to improve 1L cure rates for patients with minimal residual disease (MRD). The centers include Rocky Mountain Cancer Centers, Astera Cancer Care, and Norton Cancer Institute. Detection of MRD will use the Foresight CLARITY IUO MRD test, powered by PhasED-Seq. Enrollment is expected to complete by 1H 2026, with a potential BLA submission in 2027. The trial could expand access to CAR T therapies in community settings, where 80% of patients are treated.
Community-based practices are first to enroll in ALPHA3, signaling a move to broader CAR T adoption. This trial addresses two key questions: can circulating tumor DNA predict relapse, and does cema-cel improve cure rates compared to conventional methods? With over 19 locations in Colorado, RMCC provides comprehensive cancer care. ACC, part of OneOncology, serves over 22,000 patients annually through 13 locations. Norton Cancer Institute, with 21 locations, treats over 4,000 new patients yearly.
Allogene Therapeutics has initiated the pivotal Phase 2 ALPHA3 trial to evaluate cemacabtagene ansegedleucel (cema-cel) as part of the first-line treatment for large B-cell lymphoma (LBCL) patients likely to relapse. The trial aims to improve cure rates by using Foresight Diagnostics' CLARITY™ test to identify patients with minimal residual disease (MRD) who need further treatment. Enrollment is expected to be completed in the first half of 2026, with a Biologics License Application (BLA) submission anticipated in 2027. The trial will enroll approximately 240 patients and will assess the efficacy of cema-cel in improving event-free survival (EFS) compared to the current standard of care.
Allogene Therapeutics (Nasdaq: ALLO), a clinical-stage biotech company specializing in allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune diseases, will participate in the TD Cowen 5th Annual Oncology Innovation Summit.
The event is scheduled for May 28, 2024, at 9:30 am PT/12:30 pm ET. A webcast will be available on the company's website under the Investors section. Replays of the webcast will be accessible for approximately 30 days.
Allogene Therapeutics (Nasdaq: ALLO), a clinical-stage biotech firm, announced a $110 million common stock offering, pricing 37,931,035 shares at $2.90 each. The offering, backed by mutual funds, institutional investors, and the company's board and executives, is expected to close by May 16, 2024. Managed by Goldman Sachs, the offering is under a shelf registration statement filed in March and declared effective by the SEC in April 2024. The proceeds will be used for continued development of their AlloCAR T™ products for cancer and autoimmune diseases.
Allogene Therapeutics reported first-quarter 2024 financial results and significant business updates. Key highlights include the expansion of CD19 oncology rights to all EU member states and the UK, increasing the potential market for Cema-Cel from $6 billion in the US to $9.5 billion combined. The pivotal Phase 2 ALPHA3 trial for LBCL is set to begin mid-2024, with initial data from the Phase 1 CLL trial expected by year-end 2024. The company also announced plans for ALLO-329, targeting autoimmune diseases, with IND submission by Q1 2025 and proof-of-concept data by YE 2025. Additionally, a $15 million grant from CIRM will support the Phase 1 TRAVERSE trial in RCC, with data updates expected by YE 2024. Financially, Allogene reported a net loss of $65 million for the quarter, with $397.3 million in cash and a projected cash runway into 2026.
Allogene Therapeutics, Inc. (Nasdaq: ALLO) will report first quarter 2024 financial results and provide a business update on May 13, 2024. The company specializes in allogeneic CAR T products for cancer and autoimmune disease. A live audio webcast and conference call will follow the announcement.
Allogene Therapeutics has been awarded a $15 million grant from the California Institute for Regenerative Medicine to advance the development of ALLO-316, an AlloCAR T™ product targeting CD70 for the treatment of advanced or metastatic renal cell carcinoma. The grant supports the Phase 1 TRAVERSE trial, showing promising early anti-tumor activity and deepening responses over time in participants with advanced RCC. ALLO-316 utilizes Dagger® technology to optimize CAR T cell expansion and persistence, potentially revolutionizing solid tumor treatment.
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