Tempest Therapeutics Achieves Manufacturing Milestone for TPST-2003 CAR-T Cancer Treatment

Key Takeaways

• Tempest Therapeutics completed critical manufacturing milestone for TPST-2003 dual-targeting CD19/BCMA CAR-T therapy
• Tech transfer remains on track to support potentially registrational study initiation in Q4 2026
• Achievement follows 100% complete response rate in six evaluable patients from ongoing REDEEM-1 Phase 1/2a trial

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Tempest Therapeutics, Inc. (Nasdaq: TPST) announced April 22, 2026, that it has achieved a key manufacturing milestone for TPST-2003, its dual-targeting CD19/BCMA CAR-T cell therapy, keeping the company on track to initiate a potentially registrational study in Q4 2026.

The Brisbane, California-based clinical-stage biotechnology company reported that technology transfer activities are progressing as planned to support the expanded manufacturing capabilities needed for late-stage clinical development.

Strong Clinical Data Drives Accelerated Timeline

This manufacturing achievement builds on Tempest’s recent announcement of positive interim data from the ongoing REDEEM-1 Phase 1/2a trial. The study demonstrated a remarkable 100% complete response rate across all six efficacy-evaluable patients treated with TPST-2003.

The dual-targeting approach of TPST-2003 represents a significant advancement in CAR-T cell therapy, simultaneously targeting both CD19 and BCMA antigens. This strategy aims to address treatment resistance and relapse issues commonly seen with single-target CAR-T therapies in blood cancers.

Market Impact and Development Strategy

The successful manufacturing milestone positions Tempest to scale production capabilities necessary for larger patient populations in pivotal trials. CAR-T therapies require complex manufacturing processes, making this achievement critical for commercial viability.

Industry analysts view the 100% response rate as particularly encouraging, though larger patient cohorts will be needed to confirm these preliminary results. The accelerated development timeline suggests Tempest is prioritizing rapid advancement toward potential regulatory approval.

Next Steps in Development

With manufacturing capabilities advancing and strong early clinical data, Tempest is positioning TPST-2003 for potential breakthrough therapy designation discussions with regulatory authorities. The Q4 2026 target for initiating registrational studies represents an aggressive but achievable timeline given current progress.

The company continues enrollment in the REDEEM-1 trial while preparing for the next phase of development that could support a biologics license application.

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Frequently Asked Questions

What makes TPST-2003 different from other CAR-T therapies?

TPST-2003 is a dual-targeting CAR-T therapy that simultaneously targets both CD19 and BCMA antigens, potentially reducing treatment resistance and relapse rates compared to single-target approaches.

When could TPST-2003 become available to patients?

Tempest plans to initiate potentially registrational studies in Q4 2026. If successful, the therapy could potentially reach market by 2028-2029, pending regulatory approval.

How significant is the 100% response rate in early trials?

While promising, the 100% complete response rate is based on only six evaluable patients in early-stage trials. Larger studies will be needed to confirm this efficacy in broader patient populations.