Bcell

US-based biopharmaceutical firm Epizyme has reacquired global rights of its EZH2 programme, including EPZ-643, from Japanese partner Eisai.

As part of the deal, Epizyme will take the responsibility of the programme for global clinical development, manufacturing and commercialisation in all countries outside of Japan.

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EPZ-6438 is a first-in-class inhibitor of EZH2 that is currently being assessed in a Phase I/II clinical trial to treat B-cell non-Hodgkin lymphoma (NHL) and INI1-deficient solid tumours such as synovial sarcoma and malignant rhabdoid tumour.

Epizyme president and CEO Dr Robert Gould said: "Obtaining global control of EPZ-6438, a very promising clinical asset, represents an important milestone in the evolution of the company."

"It became clear to us that having worldwide development and commercialisation responsibility for a targeted therapeutic such as 6438 would be transformative for Epizyme."

"As we began to see the quality and duration of the responses, including two complete responses, in relapsed and refractory NHL and INI1-deficient patients treated with EPZ-6438 as a monotherapy, it became clear to us that having worldwide development and commercialisation responsibility for a targeted therapeutic like 6438 would be transformative for Epizyme."

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Under the terms of the deal, Eisai will receive a $40m upfront payment from Epizyme, with a total of up to $20m in potential clinical milestone payments and up to $50m in potential regulatory milestone payments.

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Epizyme intends to begin a five-arm Phase II trial in about 150 patients with NHL, following completion of the transition of EPZ-6438.

The company is also planning to start a Phase II study in adults with INI1-deficient tumours, including synovial sarcoma, and a Phase I study in children with INI-1 deficient tumours, comprising malignant rhabdoid tumours.

Epizyme will also continue the clinical pharmacology studies, which are part of the both firms clinical plan.

Image: CSF cytology of a diffuse large B-cell non hodgkin lymphoma. Photo: courtesy of Jensflorian.