Hemogenyx and Nitto Denko to Test Lipid Nanoparticle Delivery of FLT3 CAR mRNA

Hemogenyx Pharmaceuticals plc entered a feasibility study agreement with Nitto Denko Corporation to evaluate whether Nitto's cell-targeted lipid nanoparticle technology can deliver Hemogenyx's messenger RNA encoding its FLT3-targeting chimeric antigen receptor to human T cells, Stock Titan reported on October 19, 2026. The in vitro study is expected to take approximately four months.

How the Hemogenyx and Nitto Denko Study Works

Under the agreement, the parties will test whether Nitto's ctLNP drug delivery technology can carry Hemogenyx's FLT3-CAR mRNA into human T cells. Each party retains ownership of its own technology. Hemogenyx said the study is its first step toward an in vivo CAR-T approach, in which a patient's T cells are reprogrammed inside the body by an injectable medicine rather than engineered individually in a manufacturing facility.

Hemogenyx's lead product candidate, HG-CT-1, is an autologous CAR-T cell therapy: each dose is made from the individual patient's own T cells, which are collected, genetically engineered and expanded outside the body before being returned to that patient. Hemogenyx said an in vivo product built on its FLT3-CAR could, if technically feasible, broaden the reach and commercial potential of its CAR-T technology. The company's ongoing Phase I clinical trial of HG-CT-1 in relapsed or refractory acute myeloid leukemia is unaffected and remains its principal focus.

Dr Vladislav Sandler, Chief Executive Officer and Co-Founder of Hemogenyx Pharmaceuticals, said: "Autologous CAR-T therapy works, but every dose is a bespoke manufacturing campaign for a single patient. In vivo CAR-T offers a fundamentally different model: a drug-like product, made at scale and available off the shelf, that instructs the patient's own T cells to become CAR-T cells inside the body."

Nitto Denko, based in Japan, manufactures high-performance materials, including medical-related products and services. Nitto Denko agreed with Resonac Holdings in September 2026 to invest in a U.S.-based fund focused on AI hardware makers, Nikkei Asia reported.

Hemogenyx's Funding and Manufacturing Record

According to akta.pro company records, Hemogenyx established manufacturing infrastructure in Estonia through a letter of intent with Cellin Technologies OÜ in September 2025 and a £3.0 million institutional subscription at £8.01 per share in April 2026, enabling early commercialisation of HG-CT-1 under the hospital exemption pathway. The same records show a March 2026 technology transfer of HG-CT-1 manufacturing to CDMO Made Scientific and a comparability data package submitted to the FDA. Hemogenyx was admitted to the London Stock Exchange Main Market on 23 December 2025, increasing total issued shares to 6,041,255.

Earlier Hemogenyx Collaboration Agreements

In August 2026, Hemogenyx signed a definitive collaboration agreement with Cellin Technologies OÜ for the manufacturing and clinical implementation of HG-CT-1 in Estonia under the Hospital Exemption framework, Stock Titan reported. In July 2026, Hemogenyx signed a letter of intent with the National Cancer Centre at Vilnius University Hospital Santaros Klinikos in Lithuania for a clinical and scientific collaboration focused on FLT3-positive acute myeloid leukemia and myelodysplastic syndromes, FinancialContent Business Page reported.

What Comes Next for the Study

The study is an in vitro evaluation expected to take approximately four months, with each party retaining ownership of its own technology.