Hemogenyx signs LOI for CAR-T therapy collaboration in Lithuania

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Key Highlights

Hemogenyx Pharmaceuticals plc has entered a Letter of Intent with Vilnius University Hospital Santaros Klinikos to collaborate on FLT3-positive AML and MDS treatments. The partnership includes translational research and point-of-care manufacturing of HG-CT-1 therapy under Lithuania's hospital exemption framework. Hemogenyx retains full IP ownership while continuing Phase 1 trials in adults and pediatrics in the US.

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Hemogenyx Pharmaceuticals plc (LSE:HEMO) has signed a Letter of Intent ("LOI") with the National Cancer Centre at Vilnius University Hospital Santaros Klinikos to establish a scientific and clinical collaboration targeting FLT3-positive acute myeloid leukemia ("AML") and myelodysplastic syndromes ("MDS"). The agreement, announced on July 29, 2026, creates a pathway for the in-hospital manufacturing and compassionate-use administration of Hemogenyx's FLT3-directed CAR-T cell therapy, known as HG-CT-1, to eligible patients in Lithuania. This move allows the London-based biopharmaceutical company to generate clinical experience under Lithuania's hospital exemption framework while retaining full ownership of its intellectual property and regulatory rights.

The collaboration comprises two complementary workstreams designed to address the high unmet medical need in relapsed or refractory ("R/R") blood cancers. Workstream 1 is a translational research program led by Andrius Žučenka, MD, PhD, of the hospital, which will characterize FLT3 expression and biology across AML/MDS genetic subtypes and disease compartments, including cerebrospinal fluid and myeloid sarcomas. Workstream 2 focuses on establishing point-of-care manufacturing of HG-CT-1 at the National Cancer Centre and administering the therapy to eligible patients on a compassionate-use basis. Dr Vladislav Sandler will coordinate the effort on Hemogenyx's side, while Prof. Dr. Med. Laimonas Griškevičius will lead the clinical side at the hospital.

Under the terms of the LOI, Hemogenyx will provide the scientific information, materials, technology transfer, and training required for the manufacturing and administration of the therapy. The hospital will act as the local manufacturing, clinical, and research partner, providing access to consented patient samples and leading engagement with Lithuanian and European regulatory authorities. Both parties may receive compensation from or through the Lithuanian Compulsory Health Insurance Fund, subject to negotiation in definitive agreements. This collaboration is separate from another potential partnership in Estonia that the company disclosed was nearing finalization in September 2025.

Alongside the new partnership, Hemogenyx provided updates on its wider development activities. The company 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 an increased dose level. Additionally, Hemogenyx has initiated a pediatric Phase 1 clinical trial, with the first pediatric patient currently undergoing screening for eligibility. The company noted that while hospital partners remain committed, the timing of patient testing cannot be predicted due to the inherent difficulties of recruiting participants with severe health conditions.

Hemogenyx also continues to develop its Chimeric Bait Receptor ("CBR") platform and CDX bispecific antibody for R/R AML, though progress on these programs is deliberately measured as the company prioritizes resources for its lead candidate, HG-CT-1. The Board emphasized that it is managing resources conservatively during the patient recruitment process. Dr Vladislav Sandler, Chief Executive Officer and Co-Founder, stated that the LOI represents a pragmatic route to generate clinical experience while retaining full ownership of the technology.

Collaboration Structure and Roles

Workstream Focus Area Key Personnel Objective
Workstream 1 Translational Research Andrius Žučenka, MD, PhD (Hospital); Hemogenyx team Characterize FLT3 expression across AML/MDS subtypes and disease compartments
Workstream 2 Manufacturing & Clinical Use Dr Vladislav Sandler (Hemogenyx); Prof. Dr. Med. Laimonas Griškevičius (Hospital) Establish point-of-care manufacturing and administer HG-CT-1 under hospital exemption rules

What the Numbers Show

The strategic focus on HG-CT-1 is evident in Hemogenyx's resource allocation. By deliberately slowing the development of its CBR platform and CDX bispecific antibody, the company is concentrating its limited capital and operational bandwidth on its lead product candidate. This prioritization suggests that the success of HG-CT-1's Phase 1 trials in both adult and pediatric cohorts is critical to the company's near-term viability and future commercialization prospects. The decision to pursue compassionate-use pathways in Lithuania alongside US trials indicates a strategy to accelerate real-world data generation without the full regulatory burden of a traditional marketing authorization application at this stage.

Disclaimer: This article is AI-generated using data from ViewTrade. ScanX is not liable for any inaccuracies.

How might the clinical data generated from Lithuania's compassionate-use program influence the design or timeline of Hemogenyx's upcoming Phase 2 trials for HG-CT-1?

What are the potential financial implications for Hemogenyx if compensation negotiations with the Lithuanian Compulsory Health Insurance Fund fail to reach a definitive agreement?

Could the success of the hospital exemption model in Lithuania serve as a replicable blueprint for Hemogenyx to expand compassionate-use partnerships in other European markets beyond Estonia?

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