On April 22, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, reported that it has achieved a key milestone in the development of TPST-2003, Tempest’s dual-targeting CD19/BCMA CAR-T therapy under development for the treatment of relapsed/refractory multiple myeloma ("rrMM"). Earlier this month, Tempest’s manufacturing partner, Cincinnati Children’s Applied Gene and Cell Therapy Center ("AGCTC"), took delivery of the TPST-2003 lentiviral vector, a critical component used in the manufacturing of TPST-2003. This milestone supports Tempest’s plans to initiate the first potentially registrational study to evaluate a dual-targeting CAR-T therapy in patients with rrMM, including patients who are experiencing extramedullary disease ("EMD"), later this year.
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Tempest recently announced that, as of a January 31, 2026 data cutoff, a total of 36 patients with rrMM had received one infusion of TPST-2003, including 24 patients in a prior Phase 1/2 investigator-initiated trial ("IIT") and 12 patients in the ongoing REDEEM-1 trial, representing one of the largest datasets evaluating a CD19/BCMA dual-targeting CAR-T therapy. As of the data cutoff, all six efficacy evaluable patients enrolled in the REDEEM-1 trial had achieved a complete response according to the International Myeloma Working Group uniform response criteria. Among 25 evaluable patients with measurable disease at baseline across both studies, the overall response rate was 100% (25/25). The IIT also demonstrated durable disease control, with median progression-free survival ("PFS") of 23.1 months across all patients and median PFS of 23.1 months in patients with EMD. Tempest plans to present the results of the REDEEM-1 trial and updated results from the IIT at a scientific meeting later this year.
"We are pleased by the rapid progress we have been making in partnership with AGCTC," said Dr. Matt Angel, President and Chief Executive Officer of Tempest. "The delivery of lentiviral vector, which is a critical component in the manufacturing of autologous CAR-T products, has enabled us to proceed with the manufacturing activities required for the pivotal development of TPST-2003. We are grateful for our partnership with AGCTC, and we are looking forward to continued rapid progress toward the initiation of a potentially registrational study for TPST-2003 later this year."
AGCTC is a research, development, and manufacturing hub advancing future cell and gene therapy (CGT) treatments for patients with unmet needs. Established in 2001, the center has evolved into a nationally recognized leader in CTG CDMO services with a proven track record that reflects Cincinnati Children’s commitment to solving unmet medical needs through translational science. AGCTC is part of the Cincinnati Children’s Cancer and Blood Diseases Institute, which is ranked #1 in the nation by U.S. News & World Report for pediatric cancer care.
"We are excited to have achieved this important milestone in the development of TPST-2003," said Dr. Chaozhong Zou, Executive Director and General Manager of AGCTC, Cancer and Blood Diseases Institute, Cincinnati Children’s Hospital Medical Center. "The clinical data generated so far support the idea that the parallel-structure dual-targeting CAR architecture of TPST-2003 could offer patients with rrMM a meaningful new treatment option, and we are grateful to be in position to support the development of TPST-2003 by leveraging our extensive experience making novel CAR-T programs IND-ready. We look forward to generating the information needed to support the pivotal development of TPST-2003."
About TPST-2003
TPST-2003 is an autologous CD19/BCMA dual-targeting CAR-T therapy designed to improve response depth and durability in patients with relapsed/refractory multiple myeloma ("rrMM") through a parallel dual-targeting CAR structure designed to address tumor heterogeneity and antigen escape. TPST-2003 is being developed in China by Tempest’s partner, Novatim Immune Therapeutics ("Novatim"). Under its agreement with Novatim, Tempest has the exclusive right to develop TPST-2003 outside of China, India, Turkey, and Russia.
About REDEEM-1
REDEEM-1 (Study nos. CTR20233309/NCT06223646) is a Phase 1/2a clinical trial evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The REDEEM-1 trial has a targeted full enrollment of 29 patients. The REDEEM-1 trial is sponsored and being conducted by Tempest’s partner, Novatim Immune Therapeutics, with a total of eight clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), The First Affiliated Hospital of Nanchang University (Dr. Fei Li), Peking University First Hospital (Dr. Yujin Dong), Henan Cancer Hospital (Dr. Baijun Fang), Shanxi Provincial Cancer Hospital (Dr. Liping Su), The Second Xiangya Hospital of Central South University (Dr. Hongling Peng), The First Affiliated Hospital of China Medical University (Dr. Xiaojing Yan), and The Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College (Dr. Dehui Zou).
Additional clinical trials evaluating TPST-2003
A Phase 1/2 IIT (Study no. NCT04714827) is evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The IIT is sponsored and being conducted by Tempest’s partner, Novatim, with a total of two clinical sites registered in China: Shanghai Fourth People’s Hospital (Dr. Weijun Fu; lead site) and Shanxi Provincial Cancer Hospital (Dr. Liping Su).
A Phase 1 trial (Study nos. CTR20242409/NCT06518876) is evaluating TPST-2003 in patients with POEMS, a rare blood disorder caused by abnormal plasma cells. The Phase 1 trial is sponsored and being conducted by Tempest’s partner, Novatim, with a total of three clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), Xuanwu Hospital Capital Medical University (Dr. Wanling Sun), and West China Hospital, Sichuan University (Dr. Yu Wu).
(Press release, Tempest Therapeutics, APR 22, 2026, View Source [SID1234664691])