CAMBRIDGE, MA, 8-Oct-2025 — /EuropaWire/ — CREATE Medicines, Inc. (formerly Myeloid Therapeutics, Inc.) today announced an expanded strategy to move beyond myeloid-focused in vivo programming toward multilineage immune programming, including T cells, myeloid cells, and NK cells, to deliver scalable, redosable, off-the-shelf therapies with greater clinical impact.
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
The training module received the distinction after PDA demonstrated to ICH that it meets the twelve eligibility criteria for the program. Among these are its mission to serve as a neutral convening platform to engage expert stakeholders from industry, academia, advocacy groups, non-profits, and/or regulatory agencies on critical regulatory topics, and its promotion of regulatory convergence to accelerate innovation and improve healthcare globally.
The free “ICH Q7 GMP for APIs†training module introduces and improves understanding of the ICH quality guideline, Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. The webinar is intended for pharmaceutical professionals working with APIs. More information on the webinar is available here: https://www.pda.org/global-event-calendar/ich-q7-gmp-for-apis.
LONDON, Dec-3-2017 — /EuropaWire/ — On December 5-6, 2017, 200 high-level experts from government, academia, biopharmaceutical developers and patient organisations convene in London (UK) to address the mounting challenge of accessibility and patient access to high-value, high-cost medical therapies.
The not-for-profit executive forum is organised by the London School of Hygiene and Tropical Medicine and analytica|LASER, a global research consultancy, to investigate topical questions around drug policy, global health systems sustainability and innovation funding through a combination of case studies, panel sessions, and roundtables. Delegations are registered from over 70 public and private organisations, including the World Health Organization, as well as health systems representatives from Belgium, England, Estonia, Croatia, France, Germany, Italy, Norway, Sweden, the United States and Wales. Multiple patient organisations support the meeting to ensure that the patient voice is reflected in all deliberations.
“Access to life-saving drugs is not a new challenge. The paradigm of accessibility was changed completely in the face of the deadly HIV epidemic. This time, however, accessibility concerns almost every domain of medicine such as cancer, auto-immune diseases and rare diseases. We must act now,†says Prof Peter Piot, Director of the London School of Hygiene & Tropical Medicine and former head of UNAIDS.
“There is an incredible challenge for the sustainability of health systems across the worldâ€, says Prof. Lucien Abenhaim, London School of Hygiene & Tropical Medicine and Chairman of Analytica Laser. “It is critical that drug developers and health system engage on actionable proposals that address concerns around value, cost and overall access to innovation for the patients who need it. We are at an inflection point – the paradigms of the 1990’s can no longer guide us,†he adds.
The main plenary on December 6th features scheduled remarks by over a dozen authorities in the field, including Professor Baron Peter Piot (Director, London School of Hygiene & Tropical Medicine and former Head, UNAIDS), Dr. Olivier Brandicourt (Chief Executive Officer, Sanofi), Dr. Sarah Garner (World Health Organization), Prof. Dominique Le Guludec (President, French HAS), Sir Andrew Dillon (Chief Executive, National Institute for Health and Care Excellence UK) and Dr. Harold Paz (Chief Medical Officer, Aetna). The plenary is preceded by a scientific seminar on December 5th which gathers globally renowned academics to explore new frontiers on the methodology for the appraisal and valuation of high-value medicines.
Please contact the organisers for more information on the programming and media access, or refer to www.accessibility-symposium.org
