UK cancer-therapy company strikes deal to manufacture CAR-T treatment in Estonia

A London-listed biotech company Hemogenyx Pharmaceuticals has signed a binding agreement with Cellin Technologies, an Estonian cell-therapy company based in Tehnopol Science and Business Park, to manufacture and roll out its CAR-T therapy, HG-CT-1, for patients with relapsed or refractory acute myeloid leukemia, a form of blood cancer that has either returned or never responded to earlier treatment. The deal builds on a preliminary letter of intent signed in September 2025, and the companies say it marks the shift from planning to execution.

The arrangement works because of Estonia’s “Hospital Exemption” pathway, a rule that lets a licensed doctor use an advanced therapy that hasn’t yet received full marketing approval, so long as Estonia’s State Agency of Medicines signs off case by case. For Hemogenyx, that means patients can get access sooner, and the company can start collecting real-world data and revenue well before a full commercial approval would normally come through. Estonia’s national health insurance fund can even reimburse the cost for insured patients, which removes one of the biggest obstacles to actually getting a therapy used.

Under the agreement, Hemogenyx will spend roughly four months transferring its manufacturing know-how to Cellin, which will then produce the therapy at its GMP-certified Tallinn facility and become Hemogenyx’s exclusive Estonian partner for the next five years, handling the regulatory dossier and coordinating reimbursement. Patients, including those traveling in from other countries, will be treated at a Tallinn clinic, Taastava Kirurgia Kliinik AS. Hemogenyx keeps full ownership of the underlying science and manufacturing process, along with the right to develop and sell HG-CT-1 anywhere else in the world, and the two companies will split the net operating margin earned from every patient treated.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, said: “The signing of this definitive agreement with Cellin transforms our plans in Estonia from intent into execution. Our first priority remains saving the lives of patients with relapsed or refractory AML, for whom treatment options remain scarce. With the framework now in place for manufacturing, regulatory submission and reimbursement, we have a clear, binding path to delivering HG-CT-1 to patients and to generating the Company’s first revenues from the therapy, while gathering valuable real-world data to complement our ongoing Phase I trial.”

Ivari Saar, Board Member of Cellin Technologies, said: “Moving from a letter of intent to a definitive agreement in under a year reflects the commitment of both teams to bringing next-generation CAR-T therapy to patients in Estonia. Cellin’s GMP manufacturing infrastructure and regulatory expertise are now formally engaged to deliver HG-CT-1 under the Hospital Exemption framework, positioning Estonia at the forefront of advanced cell therapy in Europe.”

None of this is guaranteed yet. It still depends on the technology transfer going smoothly, Estonian regulators approving the Hospital Exemption dossier, and the health fund agreeing to reimburse costs – and the companies have been clear that there’s no promised minimum number of patients or minimum revenue attached.

For Cellin, which already runs its own cell therapy through this same regulatory route, the deal is a chance to expand its role as a manufacturing and clinical-delivery partner for international biotech firms. If things go to plan, Estonia would become one of the first places where HG-CT-1 reaches patients outside a formal clinical trial, putting the small Baltic country at the center of a fast-moving corner of cancer treatment.

Cellin Technologies is located at Tehnopol Science and Business Park and is part of Tehnopol’s campus community. The company is also a member of Tehnopol’s healthtech community.