Capstan Therapeutics Announces Initiation of Phase 1 Trial of Lead In Vivo CAR-T Therapy, CPTX2309, for Treating Autoimmune Disease

• CPTX2309 is a targeted lipid nanoparticle that delivers an anti-CD19 CAR mRNA preferentially to CD8-expressing cytotoxic T cells
• mRNA-based approach is designed to achieve rapid, deep, and transient B cell depletion without the need for chemotherapy, cell manipulation, viral vectors, and DNA integration
• First-in-human clinical trial underway to evaluate safety, tolerability, and pharmacodynamic activity of CPTX2309 in healthy volunteers

Excerpt from the Press Release:

SAN DIEGO–(BUSINESS WIRE)–Capstan Therapeutics, Inc. (“Capstan”), a clinical-stage biotechnology company dedicated to advancing in vivo reprogramming of cells through RNA delivery using targeted lipid nanoparticles (tLNP), today announced successful dosing of the first participants in its Phase 1 trial of CPTX2309, Capstan’s lead anti-CD19 in vivo CAR-T candidate, for the treatment of B cell-mediated autoimmune disorders.

The Phase 1 trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic activity (i.e., peripheral B cell depletion and recovery) of CPTX2309 treatment in healthy volunteers at various dose levels. Preclinical studies demonstrated rapid, deep, and transient B cell depletion in blood and tissues, which supported the clinical evaluation of CPTX2309 at the planned dose levels and regimens.

“With CPTX2309, our therapeutic goal is to achieve immune reset through rapid and profound B cell depletion using a transient, tunable, and fully off-the-shelf in vivo CAR-T technology,” said Ramin Farzaneh-Far, M.D., Chief Medical Officer at Capstan. “

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