Allogene Therapeutics (ALLO) Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase 2024 summary

Key program updates and strategic focus

• Lead asset cema-cel is now focused on first-line consolidation in large B-cell lymphoma, targeting patients with minimal residual disease (MRD) after initial chemoimmunotherapy.

• The ALPHA3 trial aims to treat patients before disease recurrence, leveraging CAR T's curative potential earlier in the treatment pathway.

• Shifting from relapsed/refractory to earlier-line therapy increases the addressable market to about 15,000 patients in the U.S. and a $5B opportunity across the U.S., Europe, and U.K.

• Allogeneic CAR T offers off-the-shelf access, enabling treatment at community centers and overcoming referral and manufacturing barriers seen with autologous CAR T.

• Ten of the planned 50 ALPHA3 study sites are already initiated, with most being community centers.

ALPHA3 study design and execution

• The ALPHA3 trial is a randomized study enrolling about 240 MRD-positive patients post-chemoimmunotherapy, comparing cema-cel to standard observation.

• Two lymphodepletion regimens are being tested: FC (fludarabine/cyclophosphamide) and FCA (with ALLO-647 antibody).

• Primary endpoint is event-free survival; secondary endpoints include PFS, OS, and MRD conversion.

• Enrollment is expected to complete in the first half of 2026.

• Heavy focus on community-based cancer centers to maximize patient access and streamline logistics.

Diagnostic innovation and MRD testing

• MRD testing in large B-cell lymphoma uses a circulating DNA-based assay developed with Foresight Diagnostics.

• The Clarity test offers high sensitivity (90%) and specificity (97%+), enabling precise patient selection.

• MRD-negative patients rarely relapse, while MRD-positive patients typically recur within 4-6 months.

• High test accuracy drives strong interest from community sites and reduces patient anxiety about recurrence.