Tempest Selects Cincinnati Children’s AGCTC for TPST-2003 Tech Transfer Ahead of Q4 2026 IND
Tempest Therapeutics tapped Cincinnati Children’s AGCTC for tech transfer and IND-enabling manufacturing of its dual-targeting TPST-2003 CAR-T therapy, with all activities, except long-term stability, due by Q3 2026 to enable a Q4 IND filing. Interim REDEEM-1 data show 100% CR in six evaluable patients and 100% ORR in 25.
1. Tech Transfer Partnership with AGCTC
Tempest Therapeutics has engaged Cincinnati Children’s Applied Gene and Cell Therapy Center as its lead contract development and manufacturing partner for TPST-2003. AGCTC will execute formal technology transfer, process development and IND-enabling manufacturing leveraging its cell and gene therapy expertise.
2. IND-Enabling Manufacturing and Timeline
All activities other than long-term stability testing are slated for completion by the end of Q3 2026. This schedule is designed to support a potential IND filing in Q4 2026, paving the way for a planned U.S. registrational study.
3. REDEEM-1 Trial Interim Efficacy Data
Interim results from the REDEEM-1 Phase 1/2a trial demonstrate a 100% complete response rate in all six efficacy-evaluable patients as of January 31, 2026. Among 25 patients with measurable disease at baseline across two studies, the overall response rate also reached 100%, highlighting TPST-2003’s potential in relapsed/refractory multiple myeloma.