TEMPEST THERAPEUTICS INC · Data as of 2026-09-08
2026
The observed safety profile (no Grade ≥3 CRS or ICANS), together with the consistency of responses observed in the REDEEM-1 trial continue to support Tempest's plan to pursue its objective of meeting with the FDA to discuss initiating a U.S. registrational study later this year.Source filing
2026
Submit a U.S. IND application and, subject to clearance, initiate a Phase 2b U.S. registrational study of TPST-2003 in patients with rrMM in 2026Source filing
2026
Tempest expects initial clinical data from both programs later this year and believes this platform approach may allow these therapies to ultimately benefit a larger number of patients.Source filing
2027
FPI in Phase 2 study expected in 1H26, data in 2027Source filing
2027
The transaction brought Tempest a portfolio of next-generation CAR-T assets, including TPST-2003, a clinical-stage dual-targeting CD-19/BCMA CAR-T with strategic partner-funded biologics license application ("BLA") filing in China planned for 2027.Source filing
H1 2027
Executed a development collaboration with Senlang Biotechnology to advance certain in vivo CAR-T product candidates, including TPST-4003, a CD7-targeted next-generation in vivo CAR-T, with first patient dosing anticipated in the fourth quarter of 2026 and initial clinical data expected in the first half of 2027Source filing
Q4 2026
We plan to collaborate with Senlang to develop TPST-4003, beginning with the IIT in China which is expected to enroll approximately 10 patients, with first patient dosing anticipated in the fourth quarter of 2026 and initial clinical data expected in the first half of 2027.Source filing