Hemogenyx Pharmaceuticals plc (LSE: HEMO) has announced the signing of a Letter of Intent (LOI) with Cellin Technologies OÜ, an Estonian cell therapy company, to commercialize its HG-CT-1 CAR-T cell therapy for relapsed or refractory acute myeloid leukemia (R/R AML) in Estonia.
The collaboration marks the first potential near-term revenue opportunity for Hemogenyx's HG-CT-1 therapy.
The LOI is said to leverage Estonia's hospital exemption pathway, amended in April 2025, which allows the use of certain advanced therapy medicinal products (ATMPs) not yet fully authorized for commercial marketing, provided preclinical or Phase I clinical trial data is sufficient.
The scheme provides an opportunity to secure reimbursement via the Estonian National Health Fund. This framework allows Hemogenyx to generate revenue while expanding real-world clinical data to support ongoing trials.
Under the terms of the LOI, Hemogenyx retains full ownership of the intellectual property, know-how, data, and regulatory rights related to HG-CT-1.
Cellin will act as Hemogenyx's local partner in Estonia, managing manufacturing, regulatory submissions, and operational support, including securing permits from the Ministry of Health and facilitating therapy administration.
Cellin will receive compensation for its services, defined in subsequent agreements. The LOI is non-binding, setting the stage for further definitive agreements.
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, stated: “Our first priority is to save the lives of patients with relapsed or refractory AML, for whom treatment options remain scarce.
“Building on this mission, the partnership with Cellin also creates a path to generate initial revenues from HG-CT-1 under Estonia's hospital exemption pathway, while providing valuable real-world patient data to complement our Phase I trial and support the future development and commercialization of the therapy.”
Ivari Saar, Board Member of Cellin Technologies, said: “We are thrilled to partner with Hemogenyx Pharmaceuticals to bring next-generation CAR-T therapy to Estonia, marking a major milestone for patients with acute myeloid leukemia and other hard-to-treat blood cancers.
“This collaboration positions Estonia at the forefront of advanced cell therapy in Europe, combining scientific innovation with a commitment to accessible care. Together, we aim to demonstrate how CAR-T can deliver transformative outcomes for patients across the EU.”
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