Release Date: March 18, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you provide more details on the status of the Phase 2 study, including enrollment and data timelines? Also, what are the main focuses for 2025 regarding 797 in gastric cancer and GVHD? A: We plan to advance 797 in both gastric cancer and GVHD this year. The Phase 2 study has the majority of patients enrolled, and we expect to present data in the second half of the year. Our focus for 2025 includes advancing our next-generation pipeline, particularly the FAP CAR-iNKT, which is on track for clinical trials in 2025.
Q: What feedback have you received from KOLs regarding the AACR IO presentation, and do you see a path for accelerated approval based on your data? A: KOLs, including lead investigator Dr. Yelena Injigin, are very supportive and motivated by the trial's progress. We are accumulating data to demonstrate clinical benefits and will engage in regulatory discussions to explore the most efficient path for approval, especially given the unmet need in second-line gastric cancer.
Q: How does the iNKT approach in the PRAME-TCR program differentiate from other cell therapy approaches? A: iNKT cells offer unique advantages such as no need for HLA matching, no lymphodepletion, and durable responses. They recruit conventional T cells and NK cells, providing a potent and selective response. Our PRAME-TCR program targets intracellular tumor antigens with high specificity, setting it apart from other therapies.
Q: What is the status of the graft-versus-host disease study funding from NIAID, and what are your backup plans if funding is delayed? A: The funding situation is fluid, but we are optimistic due to the program's importance. We have designed the trial and submitted it to regulatory boards. As a backup, we are exploring specific financing options to advance the trial, complementing potential non-dilutive government funding.
Q: Can you provide an update on MiNK's financial position and cash runway? A: Based on our financial projections and internal efficiencies, we have sufficient cash to sustain operations through the end of 2025.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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