Jazz and Redx in milestone inhibitor agreement

Jazz Pharmaceuticals and Redx announce that pan-RAF inhibitor will enter clinical development

Ireland-based Jazz Pharmaceuticals and Redx have announced that the US Food and Drug Administration (FDA) has cleared an application for JZP815.

The therapy is a pan-RAF inhibitor for the treatment of solid tumours and haematologic malignancies that contain mutations in the MAPK pathway. This enables Jazz to proceed with initiating a clinical trial for JZP815, resulting in a payment of $5m from Jazz to Redx.

The milestone sum was triggered under the agreement in which Jazz acquired Redx’s pan-RAF inhibitor programme, which was announced on 10 July 2019. Redx carried out development activities up to the completion of IND-enabling studies and the payment comes on top of $6.5m already received under the collaboration.

Meanwhile, Redx remains entitled to development, regulatory and commercial milestone payments, as well as incremental tiered royalties based on any future net sales.

JZP815 has a differentiated mechanism of action and Jazz expects to assess it as a therapy for several types of difficult-to-treat solid tumours where there remain significant unmet patient needs. Jazz expects to advance JZP815 into a phase 1 clinical programme and – when initiated – JZP815 will be the fifth compound discovered by Redx to enter the clinic.

Lisa Anson, CEO at Redx, enthused: “I am delighted that the IND application for the pan-RAF inhibitor, JZP815, has been accepted. When Jazz commence the clinical programme this will become the fifth drug candidate discovered by Redx to enter the clinic, further validating our world-class research and development capabilities. We value the strong relationship we have built with Jazz Pharmaceuticals and look forward to continuing our work together.”

Rob Iannone, Executive Vice President at Jazz Pharmaceuticals, added: “We’re excited to advance JZP815, a precision pan-RAF inhibitor with a differentiated mechanism of action, into a clinical trial programme. JZP815 may represent a significant advancement in the pan-RAF inhibitor class by not inducing paradoxical pathway activation that can stimulate the growth of certain cancers.”

Jazz and Redx also have a separate collaboration agreement to discover and develop drug candidates in the RAS-RAF-MAP kinase pathway.

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