Resolution Therapeutics has partnered with Blood Centers of America to support cell collection and processing for its planned US clinical programme for experimental therapy RTX001 in end-stage liver disease.

Partnership targets community-based treatment

The partnership is intended to support Resolution’s planned pivotal clinical programme for RTX001, which the company expects to begin in the US in 2027. Blood Centers of America (BCA) will act as one of Resolution’s preferred providers of cell collection and processing services for participating clinical sites that require this support.

Resolution is developing RTX001 as a Regenerative Macrophage Therapy (RMT) for patients with end-stage liver disease (ESLD) and decompensated cirrhosis.

The company says the partnership is intended to address one of the practical challenges associated with cell therapy: providing treatment and associated services closer to where patients live.

Patients with decompensated liver disease can face difficulties travelling to specialist transplant centres. Resolution said most decompensated patients are managed in community settings, while liver transplantation is limited by donor availability and access to transplant centres.

Amir Hefni, chief executive officer of Resolution Therapeutics, said: “RTX001 is intentionally designed and manufactured to address the historical limitations impacting cell therapy adoption in a community-based setting. Our partnership with the Blood Centers of America, Inc. will ensure patients can receive treatment with the doctor they trust, close to home.”

BCA to support cell collection and processing

BCA is a network of independent blood-centre organisations across the US. Resolution said its members have experience in blood collection and processing for autologous cell therapy trials, as well as product handling and storage.

The partnership will therefore provide infrastructure for clinical sites that need support with cell collection and processing as the RTX001 programme progresses.

Bill Block, chief executive officer of Blood Centers of America, said the partnership will use the network’s national apheresis footprint, together with product handling and storage capabilities, to support healthcare organisations involved in the programme.

For cell therapies, apheresis can be used to collect a patient’s cells for further processing before they are returned as part of treatment. Establishing this infrastructure across multiple locations can be an important consideration when clinical programmes expand beyond specialist centres.

Resolution said RTX001 is administered as a repeat-dose regimen through a peripheral intravenous infusion and does not require pre-conditioning, bridging therapy or lymphodepletion. The company is developing the therapy for patients with ESLD, where it aims to address inflammation and fibrosis through its RMT approach.

RTX001 programme moves towards US development

Resolution plans to initiate a pivotal study of RTX001 in patients with ESLD across the US in 2027, following a pre-IND meeting with the FDA. The company said the study design and clinical sites will be finalised following that process.

The BCA partnership follows the ongoing Phase 1/2 EMERALD trial of RTX001 in the UK and Spain. Resolution announced on 11 September that the final patient had been treated in the study, with 15 patients dosed and interim clinical data expected in Q4 2026.

RTX001 is engineered with IL-10 and MMP-9 and is intended to enhance the anti-inflammatory and anti-fibrotic effects of Resolution’s RMT approach. The company is also developing additional RMT programmes in inflammatory and fibrotic diseases, including lung fibrosis, alongside an in vivo RMT programme.

The BCA agreement does not itself establish efficacy for RTX001 or guarantee future commercial availability. Its immediate role is to provide collection and processing infrastructure for the company’s planned US clinical development programme.