- Four Core Programs Leverage Unique Attributes in Product Development and Trial Design to Demonstrate the Unmatched Potential of an Allogeneic CAR T
- Large B-Cell Lymphoma (LBCL): Groundbreaking ALPHA3 Trial has Potential to Leapfrog Other CAR Ts and Embed Cemacabtagene Ansegedleucel (Cema-Cel, Previously ALLO-501A) in First Line (1L) Treatment in Community Cancer Centers Where Most Newly Diagnosed Patients Seek Care
- Chronic Lymphocytic Leukemia (CLL): New ALPHA2 Cohort Designed to Address a Limitation of Autologous Therapies in a Disease Where Poor T Cell Fitness is a Known Barrier to Efficacy
- Autoimmune Disease (AID): ALLO-329, Next-Generation CD19 Dagger™ Program will Focus on Scalability and Reduced or Chemotherapy-Free Lymphodepletion, Positioning Allogeneic CAR T to Transform Autoimmune Management and Meet the Demand of the Market
- Renal Cell Carcinoma (RCC): Ongoing TRAVERSE Trial Advances Scientific Innovation Underlying Dagger™ Biology to Optimize CAR T Cell Expansion and Persistence Thereby Maximizing the Potential of Allogeneic CAR T in Solid Tumors While Mitigating Treatment-Associated Inflammatory Response
- Differentiated Potential for Cema-Cel to Boost Cure Rates in the 1L Setting Expected to Decrease Demand for Later Line Treatment, Effectuating De-Prioritization of Third Line ALPHA2 and EXPAND Trials
- Company to Focus Manufacturing in Cell Forge 1 to Prepare and Scale for Future AlloCAR T™ Demand
- Prioritization Will Streamline Resources, Reduce Cash Burn and is Expected to Extend Financial Runway Into 2026
- Conference Call Scheduled for Today at 2:00 PM PT/5:00 PM ET
SOUTH SAN FRANCISCO, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced its 2024 Platform Vision that redefines the future of CAR T by leveraging the unique attributes of allogeneic CAR T products.
"Until now, CAR T development has been defined by how autologous CAR Ts are made and used. As a management team with extensive experience in both autologous and allogeneic CAR Ts, and the only Company with the breadth of data to demonstrate comparability between the two, we are uniquely positioned to potentially redefine development and trial design of allogeneic CAR T products that allows us to do what no autologous CAR T has done before," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We believe this entirely new approach to development creates an advantage for our investigational AlloCAR T™ products now and in the future while providing a clinical framework to generate far more competitive CAR T products and dramatically expand market opportunity."
The Foundation: Pivotal ALPHA3 1L Consolidation Trial in Large B Cell Lymphoma (LBCL)
In a commanding pivot for the CD19 program, the Company will focus development of its investigational product cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A) as part of the first line (1L) treatment plan for newly diagnosed and treated LBCL patients who are likely to relapse and need further therapy. The groundbreaking design of the ALPHA3 1L consolidation trial builds upon the results demonstrated in the Phase 1 ALPHA2 trial and leverages an investigational cutting-edge diagnostic test developed by Foresight Diagnostics to identify patients who have minimal residual disease (MRD) at the completion of 1L chemoimmunotherapy for treatment with cema-cel.
Although 1L R-CHOP is curative for many with LBCL, approximately 30% of patients who initially respond will relapsei. The standard of care after 1L treatment has been simply to "watch and wait" for the disease to relapse. ALPHA3 takes advantage of cema-cel as a one-time, off-the-shelf treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP, positioning it to become the standard "7th cycle" of frontline treatment available to all eligible patients with MRD. ALPHA3 builds on the growing understanding that administration of CAR T therapies to patients with low disease burden improves both safety and efficacy outcomes. Cema-cel's Phase 1 safety profile, with low rates of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), already permits its use in the outpatient setting in relapsed/refractory (r/r) patients and may further improve in patients with no radiological evidence of disease.
Start-up activities for the ALPHA3 trial have been initiated. The study will randomize approximately 230 patients who are MRD positive at the end of 1L therapy to either consolidation with cema-cel or the current standard of care (observation). The design, with a primary endpoint of event free survival (EFS), will initially include two lymphodepletion arms (one with standard fludarabine and cyclophosphamide plus ALLO-647 and one without ALLO-647).
The outcome of this pivotal trial could allow cema-cel to be embedded in the 1L setting to boost cure rates, potentially rendering later-line treatment obsolete, and making cema-cel available in community cancer centers where most earlier line patients seek care. As a result of this differentiated vision for cema-cel which competitively places its use ahead of other CAR T therapies, the Company will focus on quickly advancing this market-defining ALPHA3 trial and deprioritize the currently enrolling third line (3L) ALPHA2 and EXPAND trials.
The Higher Bar: ALPHA2 Cema-Cel Trial in Chronic Lymphocytic Leukemia (CLL)
There is a growing need for effective treatment in CLL post-Bruton tyrosine kinase inhibitors (BTKis) and B-cell lymphoma 2 inhibitor (BCL2i) therapies. While recent autologous CD19 ...