— CREATE Medicines (“CREATE”) broadens clinical programs and capabilities to expand therapeutic potential and improve patient outcomes
— Therapies tolerably program immune cells inside the human body, providing clear differentiation among competitors and significant value potential for all stakeholders
— CREATE Medicines will present at the Meeting on the Mesa today at 3:00 PM MST, underscoring its invivo CAR leadership
CREATE Medicines, Inc. (formerly Myeloid Therapeutics, Inc.) today announced an expanded strategy to move beyond myeloid-focused in vivo programming towardmultilineage immune programming, includingT cells, myeloid cells, and NK cells, to deliver scalable, redosable, off-the-shelf therapies with greater clinical impact.
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CREATE is the most advancedclinical-stage company in RNA-based in vivo CAR therapeutics, with programs targetingHER2, TROP2, and GPC3-positive solid tumors and validated targets for in vivo CAR-T mediated B cell depletion. Building on this foundation, CREATE Medicines is pioneering a new era in multi-immune programming with an expanded platform designed to deliver transformative therapies across oncology, autoimmunity, and fibrosis.
“Our clinical work in more than 40 patients has proven that we can tolerably and repeatedly program immune cells inside the body,” said Daniel Getts, Ph.D., Chief Executive Officer of CREATE Medicines. “We are now extending those capabilities to program multiple immune lineages for deeper, more durable responses, starting with MT-304, our HER2 multi-immune CAR in breast cancer. In parallel, we are advancing the first-ever RNA retrotransposon-based in vivo CAR-Tfor B-cell depletion in oncology and autoimmunity.”
Clinical Validation
CREATE Medicines has generated one of thelargest clinical datasets in the in vivo CAR field, with more than40 patients treated across multiple Phase 1 studies. These trials provide not only proof-of-mechanism but also critical insights that de-risk next generation multi-cell programs.
— Proof-of-mechanism:Paired biopsies confirmed CAR+ immune cells infiltrating tumors, with immune remodeling and CD8 T cell recruitment.
— Safety and repeat dosing:Over 200 doses delivered with a consistent, manageable safety profile and no cumulative toxicities.
— Evidence of activity:CAR expression detected in circulating immune cells, with stable disease in several patients and a confirmed partial response on treatment for 16 months.
These results validate CREATE's ability to reprogram immune cells inside the body and provide the foundation for expansion into multi-lineage programming across T cells, myeloid cells, and NK cells.
CREATE is strongly supported by a syndicate of leading life science investors, including Newpath Partners, ARCH Venture Partners, 8VC, and Hatteras Venture Partners. These firms share the company's vision to transform immunotherapy through in vivo multi-immune programming and remain highly committed to its continued success.
Pipeline Updates and Anticipated Milestones
— MT-302 (TROP2; solid tumors):Dose escalation completed; tolerable safety profile.
— MT-303 (GPC3; hepatocellular carcinoma):Dose escalation ongoing.
— MT-304 (HER2; solid tumors):First patient expected Q4 2025; first-in-classmulti-immune CARengaging NK and myeloid cells.
— Retrotransposon-based in vivo CAR-T:First all-RNA product candidate withpermanent CAR integrationfor B-cell depletion.
— Additional multi-lineage programsin preclinical development across oncology and immunology.
Platform Differentiation
At the core of CREATE's platform istargeted, programmable cell engagement:
— Selective activation:Cell-specific receptors and LNPs for precise T, myeloid, and NK cell programming.
— Flexible durability:Transient or stable CAR expression, with permanent integration via RNA-based retrotransposon technology.
— Industry-leading RNA:Up to8+ days of linear mRNA expressionwith no reactogenicity.
— Speed and scalability:Concept-to-clinic in <12 months with low-cost manufacturing.
About CREATE Medicines
CREATE Medicines (formerly Myeloid Therapeutics) is aclinical-stage biotechpioneeringin vivo multi-immune programming. Its proprietary mRNA-LNP platform directly programs immune cells inside the body to deliver scalable, repeat-dose, off-the-shelf immunotherapies. With proven human validation and next-generation RNA technology, CREATE is advancing a pipeline of in vivo CAR therapies to transform outcomes incancer, autoimmunity, and fibrosis.For more, visitcreatemedicines.com. Follow us onLinkedIn.
Business Development:partnering@createmedicines.com
Media Contact:Susan Roberts,sr@roberts-communications.com| +1-202-779-0929
Investor Contact:Candice Masse,candice.masse@astrpartners.com
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SOURCE CREATE Medicines, Inc.
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