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- CREATE Medicines, formerly Myeloid Therapeutics, secured $122 million in Series B funding from Newpath Partners, ARCH Venture Partners, and Hatteras Venture Partners to advance its in vivo CAR-T therapy pipeline. - The Cambridge-based biotech, cofounded by Pulitzer Prize-winning oncologist Siddhartha Mukherjee, is developing CAR-T therapies using myeloid cells that are generated directly inside patients' bodies rather than through traditional ex vivo manufacturing. - The company is currently testing two cancer therapies in clinical trials for breast cancer and hepatocellular carcinoma, while planning to initiate its first autoimmune disease trial in the coming months. - CREATE has positioned itself as the first fully in vivo CAR company with patient data, distinguishing it from competitors in the evolving cell therapy landscape.
- CREATE Medicines announced preclinical data for RetroT, a fully RNA-encoded gene-integration system that enables site-specific CAR insertion into T cells without double-strand DNA breaks or viral vectors. - The platform successfully integrated CD19-CAR transgenes into human T cells using LINE-1 retrotransposon machinery, demonstrating full functionality and target-specific cytotoxicity with no detectable off-target effects. - RetroT represents a potential breakthrough in precision gene editing by reducing genotoxicity associated with traditional CRISPR/Cas9 methods while maintaining the flexibility for repeat dosing. - The company's multi-immune programming platform aims to advance next-generation in vivo CAR therapies for solid tumors and autoimmune diseases using validated LNP delivery technology.
- DelveInsight's 2025 pipeline report reveals over 50 active companies developing 52+ advanced liver cancer therapies, indicating strong industry commitment to addressing this challenging malignancy. - Recent regulatory milestones include Tempest Therapeutics receiving FDA fast track and orphan drug designations for amezalpat, while Bayer initiated Phase I trials for targeted alpha radiopharmaceutical BAY 3547926. - The pipeline features diverse therapeutic approaches including immunotherapy combinations, targeted therapies, and novel mechanisms like STAT3 inhibitors and CAR-T cell therapies. - Advanced liver cancer affects patients with disease spread beyond the liver, requiring systemic treatments focused on slowing progression and maintaining quality of life with median survival often limited to months.
- Myeloid Therapeutics presented first-in-human data for MT-302 and MT-303, marking the first clinical applications of systemically administered in vivo mRNA CAR therapies. - Single-cell RNA sequencing demonstrated selective CAR expression in myeloid cells with increased pro-inflammatory gene signatures across tumor types for MT-302. - The therapies eliminate the need for ex vivo cell manipulation while delivering tumor-specific immune activation and demonstrating successful tumor penetration. - Both MT-302 targeting TROP2 and MT-303 targeting GPC3 showed favorable safety profiles and confirmed target engagement through pharmacodynamic markers.
- MT-303, a GPC3-targeting CAR mRNA therapy, is being evaluated in a Phase 1 trial (NCT06478693) for advanced hepatocellular carcinoma (HCC). - The therapy leverages myeloid cells to directly kill tumor cells and stimulate a cytokine-mediated immune response, showing promise in preclinical models. - The Phase 1 trial assesses the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-303 in adult patients with advanced or metastatic HCC. - Early clinical observations of MT-303 have shown biologic indications of proof-of-mechanism, as well as early observed safety and efficacy experience.
- In vivo CAR T-cell generation uses off-the-shelf reprogramming cassettes, potentially reducing manufacturing time and costs compared to ex vivo CAR Ts. - Clinical trials are underway to assess the safety and efficacy of in vivo CAR T-cell therapies in treating blood cancers and autoimmune diseases. - Lentiviral vectors and lipid nanoparticles (LNPs) are being explored as delivery vehicles for CAR payloads, each with unique advantages and challenges. - Researchers are expanding the application of in vivo CAR T-cell therapies beyond T cells to target myeloid cells for solid tumor treatment.
