Allogene Therapeutics Inc ALLO has announced a significant strategic shift, deprioritizing the currently enrolling third-line Phase 2 ALPHA2 and EXPAND trials of cema-cel (ALLO-501A) in lieu of pursuing a potentially pivotal ALPHA3 trial. This new trial will evaluate cema-cel as a consolidation therapy in large B-cell lymphoma (LBCL) patients in the first-line setting who are minimal residual disease positive (MRD+) following R-CHOP.
The company has already commenced start-up activities for this potentially game-changing trial.
Allogene will also initiate a new ALPHA2 cohort of 12 patients to evaluate cema-cel in chronic lymphocytic leukemia (CLL), leveraging currently active ALPHA2 U.S. trial sites to enroll patients. The company is set to begin enrollment in Q1 2024, with initial data expected by YE 2024.
Moreover, Allogene anticipates that its cash runway will be sufficient to fund operations into 2026.
In a further bold move, Allogene announced its expansion into autoimmune diseases using ALLO-329, its next-gen CD19 CAR-T equipped with its Dagger technology, with the Phase I trial of ALLO-329 in autoimmune disease expected to commence in early 2025.
Concurrently, the company has also announced a partnership with Foresight Diagnostics to develop an MRD in-vitro diagnostic (IVD) that will be used to determine eligibility in the ALPHA3 trial.
William Blair writes that the company’s recent business update marks a bold strategic move, potentially positioning it ahead of competitors in autologous and allogeneic CD19 CAR-T therapies. This decision might expand the company’s potential market significantly.
Additionally, the analyst notes that allogeneic therapies have advantages, being more accessible than autologous products and more powerful than bi-specifics.
The expansion into Chronic Lymphocytic Leukemia (CLL) is a positive step, notes William Blair, showcasing Allogene’s capability to effectively target indications suitable for allogeneic therapy.
The analyst reiterates the Outperform rating.
Price Action: ALLO shares are down 15.49% at $2.8650 on the last check Friday.
