Myeloid Therapeutics Rebrands as CREATE Medicines, Focused on Transforming Immunotherapy Through RNA-Based In Vivo Multi-Immune Programming

CREATE Medicines Unveils Next-Generation RNA Platform Targeting T, Myeloid, and NK Cells for Scalable Off-the-Shelf Immunotherapies

• 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 in vivo CAR leadership

(IN BRIEF) CREATE Medicines, Inc. (formerly Myeloid Therapeutics) has unveiled an expanded strategy to move beyond its previous myeloid cell focus toward multi-lineage immune programming that includes T cells, myeloid cells, and NK cells. This approach aims to develop scalable, redosable, and off-the-shelf RNA-based therapies with greater clinical impact across cancer, autoimmunity, and fibrosis. The company, which holds one of the largest clinical datasets in the in vivo CAR field, has successfully treated over 40 patients in early trials, showing proof-of-mechanism, a strong safety profile across 200+ doses, and evidence of antitumor activity. Building on these results, CREATE is advancing several clinical programs—MT-302 (TROP2), MT-303 (GPC3), and MT-304 (HER2)—and introducing the first RNA retrotransposon-based in vivo CAR-T therapy for B-cell depletion. With support from top investors such as ARCH Venture Partners, Newpath Partners, 8VC, and Hatteras Venture Partners, CREATE’s proprietary mRNA-LNP platform enables precise, cell-specific programming, durable CAR expression, and rapid, cost-effective development from concept to clinic in under 12 months.

CREATE is the most advanced clinical-stage company in RNA-based in vivo CAR therapeutics, with programs targeting HER2, 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-T for B-cell depletion in oncology and autoimmunity.”

Clinical Validation

CREATE Medicines has generated one of the largest clinical datasets in the in vivo CAR field, with more than 40 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-class multi-immune CAR engaging NK and myeloid cells.
• Retrotransposon-based in vivo CAR-T: First all-RNA product candidate with permanent CAR integration for B-cell depletion.
• Additional multi-lineage programs in preclinical development across oncology and immunology.

Platform Differentiation

At the core of CREATE’s platform is targeted, 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 to 8+ days of linear mRNA expression with no reactogenicity.
• Speed and scalability: Concept-to-clinic in <12 months with low-cost manufacturing.

About CREATE Medicines

CREATE Medicines (formerly Myeloid Therapeutics) is a clinical-stage biotech pioneering in 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 in cancer, autoimmunity, and fibrosis. For more, visit createmedicines.com. Follow us on LinkedIn.

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

Website:

FAQs – CREATE Medicines, Inc.

1. What is CREATE Medicines, Inc.?
CREATE Medicines, Inc. (formerly Myeloid Therapeutics, Inc.) is a clinical-stage biotechnology company pioneering in vivo multi-immune programming. The company uses a proprietary mRNA-LNP platform to directly program immune cells within the body, aiming to deliver scalable, repeat-dose, off-the-shelf immunotherapies for cancer, autoimmunity, and fibrosis.

2. What new strategy has CREATE Medicines announced?
CREATE Medicines has expanded its strategy beyond myeloid-focused immune programming to include T cells, myeloid cells, and NK cells. This multi-lineage immune programming approach is designed to enhance clinical outcomes by creating more durable and effective immune responses.

3. What makes CREATE Medicines’ approach different?
The company’s platform centers on targeted, programmable cell engagement that allows selective activation of specific immune cells. It supports both transient and permanent CAR expression, achieved through RNA-based retrotransposon technology. Additionally, CREATE’s industry-leading RNA delivers up to 8+ days of mRNA expression with no reactogenicity, and its development process moves from concept to clinic in under 12 months with low-cost manufacturing.

4. What clinical progress has CREATE Medicines achieved so far?
CREATE has treated more than 40 patients in multiple Phase 1 studies, providing one of the largest clinical datasets in the in vivo CAR field. The results demonstrated successful immune cell reprogramming inside the body, a manageable safety profile across more than 200 doses, and confirmed immune cell activity within tumors. Some patients experienced stable disease, and one achieved a partial response lasting 16 months.

5. What are CREATE Medicines’ main clinical programs?

• MT-302 (TROP2; solid tumors): Dose escalation completed with a tolerable safety profile.
• MT-303 (GPC3; hepatocellular carcinoma): Dose escalation ongoing.
• MT-304 (HER2; solid tumors): First patient expected in Q4 2025; features a first-in-class multi-immune CAR engaging NK and myeloid cells.
• Retrotransposon-based in vivo CAR-T: The first all-RNA product candidate with permanent CAR integration for B-cell depletion in oncology and autoimmunity.

6. What is the significance of CREATE’s RNA retrotransposon-based in vivo CAR-T therapy?
It represents the first-ever all-RNA product capable of permanently integrating CARs into immune cells, allowing stable and long-lasting immune responses for treating cancers and autoimmune diseases.

7. How is CREATE Medicines funded?
The company is backed by leading life science investors, including Newpath Partners, ARCH Venture Partners, 8VC, and Hatteras Venture Partners, who share CREATE’s mission to transform immunotherapy through multi-immune programming.

8. What are the upcoming milestones for CREATE Medicines?
Key upcoming milestones include the initiation of the first patient dosing for MT-304 in Q4 2025 and continued progress across ongoing studies of MT-302, MT-303, and the retrotransposon-based CAR-T platform, as well as additional multi-lineage programs in preclinical development.

9. Where can I learn more about CREATE Medicines?
For more information, visit createmedicines.com or follow the company on LinkedIn.

SOURCE: CREATE Medicines