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CREATE Medicines: A New Frontier in Immunotherapy

In a significant shift within the biotechnology sector, Myeloid Therapeutics has recently rebranded itself as CREATE Medicines, indicating a broadened focus on transforming immunotherapy. This strategic pivot embraces RNA-based in vivo multi-immune programming, aiming to enhance therapeutic potential and improve patient outcomes. CREATE Medicines is paving the way for next-generation treatments that offer a new approach to tackling various diseases, particularly within oncology, autoimmunity, and fibrosis.

Expanding Clinical Programs

Under the new banner of CREATE Medicines, the company has laid out an ambitious strategy that extends beyond its previous myeloid-centered programming. This evolution involves multi-lineage immune programming, including T cells, myeloid cells, and NK (Natural Killer) cells. By achieving scalable and repeatable therapies that can be utilized off-the-shelf, CREATE aims to provide substantial clinical impact for patients.

The company prides itself on being at the forefront of RNA-based in vivo CAR (Chimeric Antigen Receptor) therapeutics, with promising programs directed at HER2, TROP2, and GPC3-positive solid tumors. Furthermore, CREATE is validating targets for in vivo CAR-T mediated B cell depletion, marking a significant step forward in the field.

Daniel Getts, Ph.D., the CEO of CREATE Medicines, stated, "Our clinical work with over 40 patients has demonstrated our capability to program immune cells inside the human body safely and effectively. We are now expanding this capacity to program multiple immune lineages, starting with our MT-304 HER2 multi-immune CAR aimed at treating breast cancer."

Clinical Validation and Insights

CREATE Medicines boasts a remarkable clinical dataset in the in vivo CAR field, having treated over 40 patients across multiple Phase 1 studies. These trials have proven not only the feasibility of their mechanisms but also provided critical insights into the underlying principles that minimize risks associated with new multi-cell therapies.

Some key results from their clinical studies include:

• - Proof-of-Mechanism: Biopsies paired with treatments have confirmed CAR+ immune cells infiltrating tumors, showing immune remodeling alongside CD8 T cell recruitment.
• - Safety and Repeat Dosing: The program has administered more than 200 doses, showcasing an impressive safety profile without any cumulative toxicities.
• - Evidence of Activity: CAR expression has been detected within circulating immune cells, indicating stable disease in several patients, with one individual experiencing a confirmed partial response lasting 16 months.

These results affirm CREATE’s ability to not just attract, but also effectively reprogram immune cells within the body, forming a robust foundation for their ambitious plans to enhance multi-lineage programming.

Pipeline Updates and Future Outlook

CREATE Medicines has an exciting pipeline lined up, with notable programs that include:

• - MT-302 targeting TROP2 in solid tumors, where dose escalation has been completed and shown a tolerable safety profile.
• - MT-303, which focuses on GPC3 for hepatocellular carcinoma, is currently in the dose escalation phase.
• - MT-304 (HER2), expected to treat its first patient in Q4 2025, is set to be a first-in-class multi-immune CAR that positively engages NK and myeloid cells.
• - The firm is also advancing the first-ever RNA retrotransposon-based in vivo CAR-T, aiming for seamless B-cell depletion.
• - Additional multi-lineage programs are in development across oncology and immunology sectors, showcasing CREATE’s extensive reach and ambition.

Differentiation and Future Potential

What sets CREATE Medicines apart is its innovative platform that emphasizes targeted and programmable cell engagement. Key features of this platform include:

• - Selective Activation: Engaging cell-specific receptors and lipid nanoparticles (LNPs) for precise programming of T, myeloid, and NK cells.
• - Flexible Durability: Offering both transient and stable CAR expression, highlighting the benefits of permanent integration via RNA-based retrotransposon technology.
• - Leading RNA Technology: Facilitating an extended linear mRNA expression period (beyond eight days) without reactogenicity.
• - Speed and Scalability: The ability to move from concept to clinical application in less than 12 months at low manufacturing costs underlines CREATE’s operational efficiency.

Conclusion

As CREATE Medicines embraces this new chapter, it stands poised to make a significant impact on the landscape of immunotherapy. With its groundbreaking approach to programming immune cells and a robust pipeline of therapies in development, CREATE is setting the stage for a future where patient outcomes are remarkably transformed. Visit createmedicines.com for more information and updates as they continue on this pioneering journey.