Hemogenyx Signs LOI with Vilnius University Hospital for FLT3-Directed CAR-T Therapy in AML/MDS
核心洞察
Hemogenyx Pharmaceuticals signed a Letter of Intent with Vilnius University Hospital Santaros Klinikos (搜索) to collaborate on FLT3 (搜索)-positive AML and MDS research and treatment.
The collaboration includes a translational research program on FLT3 (搜索) biology and point-of-care manufacturing of HG-CT-1 CAR-T therapy under Lithuania's hospital exemption framework.
Hemogenyx retains full ownership of all intellectual property, data, and regulatory rights while advancing parallel Phase 1 trials in adults and pediatric patients in the United States.
Hemogenyx Pharmaceuticals plc (搜索) (LSE:HEMO) announced on July 29, 2026, that it has signed a Letter of Intent with the National Cancer Centre at Vilnius University Hospital Santaros Klinikos (搜索), one of Lithuania's leading academic medical centers, to establish a scientific and clinical collaboration focused on FLT3 (搜索)-positive acute myeloid leukemia (搜索) (AML) and myelodysplastic syndromes (搜索) (MDS).
The LOI establishes two complementary workstreams designed to advance both the scientific understanding and clinical treatment of these aggressive blood cancers, which carry a high unmet medical need, particularly in relapsed or refractory (R/R) patients.
Two-Pronged Collaboration Strategy
Workstream 1 comprises a translational research program that will characterize FLT3 (搜索) expression and biology across AML/MDS genetic subtypes, including patterns of disease evolution over the course of treatment. The research will also analyze FLT3 expression across disease compartments — including cerebrospinal fluid and myeloid sarcomas — in both de novo and R/R patient samples. This program will be led by Andrius Žučenka, MD, PhD, of the Hospital, in collaboration with Hemogenyx.
Workstream 2 focuses on establishing in-hospital, point-of-care manufacturing of Hemogenyx's FLT3 (搜索)-directed CAR-T cell therapy, HG-CT-1, at the National Cancer Centre and administering it to eligible AML/MDS patients on a compassionate-use basis under Lithuania's hospital exemption framework. This workstream will be coordinated on Hemogenyx's side by CEO Dr. Vladislav Sandler, with the clinical side at the Hospital led by Prof. Dr. Med. Laimonas Griškevičius.
Intellectual Property and Commercial Terms
Under the LOI, Hemogenyx retains full ownership of all pre-existing intellectual property, know-how, data, and regulatory rights relating to HG-CT-1 and its underlying FLT3 (搜索) CAR-T technology. The company shall also be entitled to revenues generated from the commercialization of the therapy. Both parties may receive compensation from or through the Lithuanian Compulsory Health Insurance Fund — the Hospital for its manufacturing, regulatory, clinical, and research services, and Hemogenyx for the materials and technology transfer used to produce the therapy. Definitive agreements remain subject to further negotiation.
Patient treatment is intended to be carried out under the hospital exemption rules and other applicable pathways in force in the Republic of Lithuania, consistent with Lithuanian and EU law governing advanced therapy medicinal products (ATMPs).
Parallel Clinical Development in the United States
The collaboration may enable Hemogenyx to receive clinical data from the treatment of R/R AML patients in Lithuania in parallel with the company's ongoing clinical trials in the United States. Hemogenyx continues its Phase 1 clinical trial of HG-CT-1 in adult patients with R/R AML, with the next adult cohort scheduled to be treated at the increased second dose level. Several patients have been identified and screened for eligibility.
Additionally, Hemogenyx has initiated a pediatric Phase 1 clinical trial of HG-CT-1. The first pediatric patient has been identified and is undergoing screening for eligibility. The company notes that it is not possible to predict the timing of patient testing, but hospital partners remain committed to the continuation of trials.
Broader Pipeline Update
Beyond HG-CT-1, Hemogenyx continues development of its Chimeric Bait Receptor (CBR) platform, with results described as promising, though development is deliberately measured as the company prioritizes its lead candidate. The CDX bispecific antibody for R/R AML is also progressing at a measured pace under the same resource-preservation strategy.
The Board acknowledged that clinical trials in R/R AML are inherently difficult, principally due to the health status of potential participants, which directly affects patient eligibility and the pace of trial progression. The company is managing its programs with this in mind and remains focused on advancing HG-CT-1 as its lead priority.
Dr. Vladislav Sandler, Chief Executive Officer and Co-Founder of Hemogenyx Pharmaceuticals, stated: "This Letter of Intent with the National Cancer Centre at Vilnius University Hospital Santaros Klinikos (搜索) is an important step in bringing our HG-CT-1 CAR-T therapy closer to patients who urgently need new options. By pairing a focused research program on FLT3 (搜索) biology with point-of-care manufacturing and compassionate-use treatment under Lithuania's hospital exemption framework, we have a pragmatic route to generate clinical experience while retaining full ownership of our technology."
The collaboration is separate from a further collaboration under discussion in Estonia, disclosed on September 23, 2025, which the company hopes is nearing finalization. Hemogenyx noted that considerable preparatory work will be required before patient treatment can begin in Lithuania.