Capstan Therapeutics Presents Preclinical Findings on CAR-T Candidate CPTX2309 at ACR Convergence 2024

Capstan Therapeutics, Inc. (“Capstan”), a biotechnology firm focused on promoting in vivo cell reprogramming via RNA delivery with targeted lipid nanoparticles (tLNP), has disclosed preclinical findings regarding CPTX2309, its primary in vivo CAR-T candidate, at the American College of Rheumatology (ACR) Convergence 2024 event in Washington, D.C.

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“The preclinical findings shared at ACR underscore the promise of our in vivo CAR-T technology, which integrates the remarkable effectiveness of a living therapeutic with the convenience, scalability, and predictability associated with biologics,” stated Ramin Farzaneh-Far, M.D., Chief Medical Officer at Capstan. “These findings provide substantial evidence to progress CPTX2309 into clinical trials in mid-2025.”

CPTX2309, developed using Capstan’s proprietary CellSeeker™ platform, delivers an mRNA payload that encodes an anti-CD19 CAR, aimed at preferentially reprogramming CD8-expressing cytotoxic T cells. The goal of this innovative strategy is to reset the immune system through significant B cell depletion in both blood and lymphatic tissues, eliminating the necessity for lymphodepletion chemotherapy and overcoming the constraints and disadvantages associated with traditional ex vivo CAR-T therapies.

Highlights from ACR Presentation:

Administration of CPTX2309 led to significant and preferential conversion of functional CD8+ CAR T cells in vitro as well as in both small and large animal studies, achieving up to 80% reprogramming of CD8+ T cells to express CAR in non-human primate (NHP) models. Minimal engineering of CD4+ T cells and B cells was noted.

A profound reduction of B cells was evident in NHP blood and tissues, alongside repopulation primarily by naïve B cells, indicating a potential immune reset. This aligns with observations made in autoimmune patients undergoing conventional ex vivo engineered CD19 CAR T treatment.

CPTX2309 effectively stimulates CD8+ T cells from patients diagnosed with myositis, systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren’s syndrome, and multiple sclerosis, achieving similar results as those obtained from healthy donors, regardless of prior treatments that included commonly used immunosuppressive drugs. The CD19-CAR-T cells generated displayed the capability to kill B cells from these autoimmune patients.

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According to the data provided by the Synapse Database, As of November 20, 2024, there are 802 investigational drugs for the CD19 target, including 287 indications, 538 R&D institutions involved, with related clinical trials reaching 1375, and as many as 44445 patents.

CPTX-2309 is an autologous CAR-T and mRNA CAR-T drug with a focus on targeting CD19. The therapeutic areas for this drug are immune system diseases, with the active indication being autoimmune diseases. The originator organization for this drug is Capstan Therapeutics, Inc. In terms of development phase, CPTX-2309 is currently in the early Phase 1 stage at a global level.