Hemogenyx Pharmaceuticals (LSE:HEMO) announced it has entered a feasibility study agreement with Nitto Denko Corporation, the Japan-based materials manufacturer listed in Tokyo, to explore an entirely different delivery model for its CAR-T technology.
The London-listed, clinical-stage biopharmaceutical group is evaluating whether Nitto's cell-targeted lipid nanoparticle technology can deliver messenger RNA encoding its FLT3-targeting chimeric antigen receptor directly to a patient's T cells inside the body.
That would mark a first step toward an "in vivo" CAR-T approach, where an injectable medicine reprogrammes T cells within the patient, rather than engineering them individually in a manufacturing facility.
Hemogenyx's lead candidate, HG-CT-1, is currently an autologous CAR-T therapy: each dose is manufactured from an individual patient's own cells, collected, engineered and expanded outside the body before being returned to that patient.
That patient-by-patient process is complex and costly, and limits how many patients and treatment centres can be served; an in vivo product, by contrast, could in principle be manufactured in large batches, held in inventory and administered without a bespoke manufacturing run for each patient.
The study combines Hemogenyx's proprietary FLT3-CAR mRNA with Nitto's delivery technology, with each party retaining ownership of its own intellectual property, and is an in vitro evaluation expected to take approximately four months.
Hemogenyx said its ongoing Phase I trial of HG-CT-1 in relapsed/refractory acute myeloid leukaemia, which is preparing to dose its next adult cohort at a higher level and has identified its first paediatric patient for screening, remains unaffected and its principal focus.
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"This Study with Nitto, a recognized leader in nucleic acid medicine and drug delivery, opens that opportunity for Hemogenyx," said Dr Vladislav Sandler, the company's chief executive and co-founder, adding that it could "considerably extend the value of our CAR-T platform" if successful.
The study follows a period of expanding partnership activity for Hemogenyx, which in August signed a definitive manufacturing agreement with Cellin Technologies in Estonia and, in July, a letter of intent with Lithuania's National Cancer Centre, both aimed at establishing hospital-exemption routes for HG-CT-1 ahead of full commercial authorisation.