Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Allogene Therapeutics Inc (ALLO, Financial) is advancing its pivotal Phase 2 ALPHA3 trial for large B cell lymphoma, which could set a new standard for first-line treatment.
- The ALLO-316 program has shown unprecedented efficacy in solid tumors, with a confirmed response rate of 33% in renal cell carcinoma patients.
- The company received RMAT designation from the FDA for ALLO-316, highlighting its potential as a breakthrough treatment for advanced renal carcinoma.
- Allogene Therapeutics Inc (ALLO) is innovating in autoimmune diseases with ALLO-329, which targets both CD19 positive B cells and CD70 positive T cells, potentially enhancing therapeutic outcomes.
- The company maintains a strong financial position with $403.4 million in cash, cash equivalents, and investments, extending its cash runway into the second half of 2026.
Negative Points
- The ALPHA3 trial for large B cell lymphoma faces challenges in site activation amid intense competition, with only 27 of the planned 50 sites activated.
- The ALLO-316 program encountered safety concerns, including grade 5 adverse events, which could impact its development and regulatory approval.
- The company reported a net loss of $66.3 million for Q3 2024, reflecting ongoing financial challenges in its development programs.
- Enrollment in autoimmune indication studies for cell therapy has been slow, which could delay the progress of the ALLO-329 program.
- The complexity of clinical trials and the competitive landscape present ongoing challenges for Allogene Therapeutics Inc (ALLO) in achieving its long-term goals.
Q & A Highlights
Q: Can you provide insight into when the RCC expansion cohort might be completed and when a pivotal trial for potential approval could start? Also, how do the 316 data read through to the 329 autoimmune program?
A: We aim to enroll approximately 20 patients in the expansion cohort to ascertain response rate and durability, with a program update expected next year. Regarding the 329 program, we are encouraged by the dagger effect seen in the 316 program and have confidence that this will carry forward into the 329 program. We plan to use chemotherapy alone in the autoimmune setting and will pressure test the ability to reduce or eliminate lymphodepletion as a key objective in the early phase of the study. - Dr. Zachary Roberts, EVP of R&D, CMO
Q: Could you give us a better sense of the grade five events reported in the data today? Were there any confounding effects that led to those cases?
A: In oncology, especially with advanced metastatic disease, adverse events are often confounded by the underlying disease and the doses used in phase one trials. Each case of adverse events, including grade five events, is complex and confounded. - Dr. David Chang, CEO
Q: How are you seeing the screening rate for MRD positivity in your first-line lymphoma study, and how is the pace of enrollment?
A: The enthusiasm and engagement from clinical trial sites have been high. The trial is progressing as planned, with community sites showing significant activity. The screening process is providing prognostic benefits to patients, even those who screen MRD negative. - Dr. Zachary Roberts, EVP of R&D, CMO
Q: Can you discuss the safety profile of ALLO-316, particularly in relation to the grade five adverse events and how this might translate into your autoimmune program?
A: The safety findings are being carefully evaluated. The grade five events are confounded by the advanced disease state of patients. The dagger technology enhances the pharmacodynamic effect of CAR T, and we are focused on finding the right balance of cell dose and lymphodepletion. - Dr. David Chang, CEO
Q: What kind of durability do you need to see in ALLO-316 to meet with the FDA on a pivotal design? What indications are you expecting to pursue with ALLO-329?
A: We have ongoing remissions at four and six months in patients treated with the phase one B regimen. The FDA's RMAT designation allows for more frequent discussions, and we await further durability data. For ALLO-329, we are focusing on rheumatologic conditions, with lupus being a primary area of interest. - Dr. Zachary Roberts, EVP of R&D, CMO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
