Pipeline

Tempest is advancing a pipeline of in vivo CAR-T product candidates for oncology and immunology applications.

In vivo CAR-T program combines clinically supported dual-CAR architecture with advanced CD7-targeted mRNA LNPs

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1For amezalpat, Phase 3 timelines are subject to a partnership and/or separate funding. TPST-1495 Phase 2 to be operationalized by the Cancer Prevention Network of the National Cancer Institute (“NCI”). TPST-2003, TPST-2206, TPST-3003, TPST-3206, and TPST-4003 clinical development in China to be operationalized by Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

“RCC” renal cancer; “HCC” hepatocellular carcinoma; “CCA” cholangiocarcinoma; “FAP” familial adenomatous polyposis; “FPI” First Patient In; “rrMM” relapsed/refractor multiple myeloma, “SLE” lupus.

TPST-4003

TPST-4003 is a preclinical, in vivo CAR-T product candidate that combines proprietary CD7-targeted mRNA/LNP delivery with a clinically validated dual-targeting CD19/BCMA CAR architecture utilized in the company's TPST-2003 CAR-T program. Targeting broad B-cell lineage depletion and reset, TPST-4003 is being designed to address a range of autoimmune and oncology indications, initially including MG and MS.

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 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.

Technology

Tempest’s in vivo CAR-T platform, CD7-tLNP, is being designed to expand the potential of next-generation of in vivo CAR-T through three core differentiators: 

  • Broader T-Cell Reach: The platform is being engineered to efficiently target both CD4+ and CD8+ T-cell populations, enabling broad CAR expression across the key cellular drivers of durable immunity. This comprehensive T-cell engagement is intended to support a more balanced and effective therapeutic response.
  • Better Delivery Logic: A differentiated targeting ligand, combined with rapid cellular internalization and a chemically optimized mRNA payload, is being designed to maximize intracellular delivery and CAR protein expression. Nucleoside-modified mRNA and optimized construct architecture work together to reduce innate immune sensing, extended functional mRNA activity, and robust yet transient CAR expression -- enhancing delivery efficiency while preserving the advantages of an in vivo approach.
  • Scalable In Vivo CAR-T: By increasing CAR expression on a per-particle basis, the platform is designed to achieve meaningful biological activity at lower doses, supporting improved manufacturing efficiency, reduced cost of goods, and the potential for scalable, repeatable treatment.