- Proprietary manufacturing process enables robust and scalable GMP-compliant manufacture of autologous engineered RMT products, including lead asset RTX001 in end-stage liver disease (ESLD).
- Novel mode of action-based candidate testing suite enabled the discovery of RTX001, which shows enhanced anti-inflammatory and anti-fibrotic effects in vitro and in vivo.
- The EMERALD Phase1/2 interventional study for RTX001 (NCT06823713) is now actively recruiting and will investigate the safety and efficacy of RTX001 in patients with ESLD who have recovered from a recent hepatic decompensation.
Edinburgh and London, UK, 14 May 2025 – Resolution Therapeutics (“Resolution” or “Company”), a clinical-stage biopharmaceutical company pioneering regenerative macrophage therapy to treat inflammatory and fibrotic diseases, shares key data from two presentations at the American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting in New Orleans, US, May 13-17, 2025.
The data are presented in two sessions:
- Oral presentation titled “Development of a manufacturing process for a Regenerative Macrophage Therapy to treat end-stage liver disease” presented by Dr Steven Howe, Vice President of Process Development at Resolution Therapeutics (Abstract: 342); and
- Poster presentation titled “Development of a mode of action-based testing suite for the screening of regenerative macrophage cell therapy candidates for end-stage liver disease and beyond” presented by Dr Lara Campana, scientific co-founder and Senior Vice President of Research & Translational Science at Resolution Therapeutics (Abstract: 1278).
Dr Amir Hefni, Chief Executive Officer of Resolution Therapeutics, said: “These advancements in our manufacturing process and candidate testing suite further support the development of our lead product RTX001 in Phase 1/2 study in ESLD. Our proprietary platform will also support the expansion of our RMT pipeline to treat patients with other inflammatory and fibrotic diseases, including lung fibrosis and graft-versus-host disease (GvHD).”
Key highlights from the oral presentation include:
- Development of a proprietary ex vivo manufacturing process enables multiple doses of autologous engineered RMT to be produced from a single leukapheresis procedure, improving convenience for patients.
- Drug product cryopreservation enables scalability of RMT for clinical and commercial development across multiple geographies.
- GMP manufacture of RTX001 is supporting by extensive quality control and analytical testing of safety, identify, quantity, purity and potency to ensure regulatory compliance.
- These advances greatly improve the scalability of RMT manufacture, supporting the development of lead asset RTX001 and future products.
Dr Steven Howe, Vice President of Process Development at Resolution Therapeutics, said: “The development of our proprietary manufacturing process has enabled the robust, consistent and scalable manufacture of RTX001 to support the EMERALD Phase 1/2 study. We have also built and incorporated a matrix of extended characterisation techniques which will enhance our understanding of RTX001 as we progress through clinical evaluation.”
Key highlights from the poster presentation include:
- Development of a novel cell-based in vitro testing suite enabled the identification IL-10+MMP9 as the optimal payload combination for RTX001.
- The testing suit recapitulates the mechanism of action (MoA) of RMT underpinning their anti-inflammatory and anti-fibrotic effects.
- For the anti-inflammatory MoA, the suite tests: phagocytosis, recruitment of monocytes, and polarisation of naïve macrophages to a regenerative phenotype.
- For the anti-fibrotic MoA, the suite tests: collagen degradation and de-activation of myofibroblasts, i.e. scar-producing cells.
- RTX001 showed superior efficacy in vitro and in vivo compared to non-engineered macrophages and IL-10 only macrophages, supporting the initiation of the Phase 1/2 EMERALD study of RTX001 in ESLD which is now actively recruiting.
Dr Lara Campana, Scientific Co-Founder and Senior Vice President of Research & Translational Science at Resolution Therapeutics, said: “This robust and versatile in vitro testing suite was pivotal in the selection of payloads IL-10 and MMP9 for our lead asset RTX001 to treat ESLD, which shows enhanced anti-inflammatory and anti-fibrotic abilities and an excellent tolerability profile. We are excited for upcoming clinical outcomes and biomarker data from our EMERALD Phase 1/2 study in ESLD.”
Contacts:
Company
Victor Dillard
Vice President, Strategy & Operations
victor.dillard@resolution-tx.com
Investors
John Norton
Precision AQ
Media
Hana Malik, Joshua Evans, Aoife Minihan
Optimum Strategic Communications
+44 20 3882 2119
NOTES TO EDITORS
About RTX001
RTX001 is an engineered autologous macrophage therapy with enhanced anti-fibrotic and anti-inflammatory effects. The product candidate is engineered with IL-10-MMP9 mRNA to enhance the natural regenerative properties of macrophages for superior efficacy and durability. RTX001 is being tested in the Phase 1/2 study called ‘EMERALD’, an open-label first-in-human study in end-stage liver disease (ESLD) measuring clinical events as the primary efficacy endpoint. The EMERALD Phase 1/2 study is now actively recruiting (NCT06823713).
About Resolution Therapeutics
Resolution Therapeutics is a clinical-stage biopharmaceutical company focused on pioneering regenerative macrophage therapy (RMT) in inflammatory and fibrotic diseases. The Company leverages its proprietary platform to develop macrophages with pro-regenerative properties for superior patient outcomes. Resolution’s initial focus is on developing RTX001, its lead product with first-in-class potential supported by preclinical data demonstrating anti-fibrotic and anti-inflammatory advantages relative to non-engineered macrophages, to treat patients with end-stage liver disease. The Company is also advancing efforts to expand the potential of its platform into inflammatory and fibrotic indications beyond liver disease, including graft-vs-host disease (GVHD) and lung fibrosis. Resolution, a spinout from Professor Stuart Forbes’s lab at the University of Edinburgh, is based in Edinburgh and London. Learn more by visiting resolution-tx.com and engage with us on LinkedIn.
About ASGCT
The American Society of Gene & Cell Therapy (ASGCT) is the primary membership organization for scientists, physicians, professionals, and patient advocates involved in gene and cell therapy. Their mission is to advance knowledge, awareness, and education leading to discovery and clinical application of gene and cell therapies to alleviate disease.