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Allogene Therapeutics (ALLO) investor relations material
Allogene Therapeutics Citi's SMID Call Series 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Pipeline overview and strategic focus
Three ongoing clinical programs: a pivotal CD19 allogeneic CAR T (SemiCell) for lymphoma, a solid tumor program (ALLO-316) for renal cell carcinoma, and a novel dual-targeting CAR (ALLO-329) for autoimmune diseases.
SemiCell is being developed for frontline consolidation in large B cell lymphoma, targeting MRD-positive patients post-remission.
ALLO-316 showed a 31% response rate in refractory metastatic RCC, with durable responses, marking a first for off-the-shelf cell therapies.
ALLO-329 incorporates Dagger technology for built-in lymphodepletion, aiming to treat autoimmune patients with minimal or no chemotherapy.
The company’s cash runway extends into 2027, with resource prioritization on the pivotal ALPHA-3 trial.
ALPHA-3 trial design and market opportunity
ALPHA-3 targets MRD-positive large B cell lymphoma patients after frontline therapy, using MRD as a sensitive blood-based marker for relapse risk.
The global market opportunity is estimated at $5 billion, as MRD testing adoption grows and captures most patients at risk of relapse.
The trial randomizes MRD-positive patients to observation or SemiCell treatment, with a futility analysis planned for the first half of 2026.
Enrollment challenges included educating physicians and patients on MRD utility and coordinating between lymphoma and transplant teams; mitigation strategies have improved enrollment rates.
The study is powered for a 30% improvement in MRD conversion, with 220 patients to be randomized.
Clinical data and rationale
Phase 1 data for SemiCell showed a 58% complete response rate in relapsed/refractory lymphoma, with even higher efficacy in patients with low disease burden.
MRD positivity is a strong predictor of relapse, and rapid progression is common, supporting the need for fast-acting, off-the-shelf therapies.
Off-the-shelf CAR T is positioned as superior to autologous options for rapid intervention in high-risk patients.
The trial’s design and endpoints are FDA-discussed and agreed upon, with event-free survival as the primary endpoint.
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