Jazz Pharmaceuticals and Redx have announced the start of clinical trials for a pan-RAF inhibitor.
The US Food and Drug Administration (FDA) has approved an application for JZP815, according to Ireland-based Jazz Pharmaceuticals and Redx.
A pan-RAF inhibitor is being developed for the treatment of solid tumours and hematologic malignancies with mutations in the MAPK pathway. This allows Jazz to move forward with starting a clinical trial for JZP815, which will result in a $5 million payment from Jazz to Redx.
The payment was made under the terms of a deal in which Jazz purchased Redx's pan-RAF inhibitor programme, which was announced on July 10, 2019. The payment comes on top of the $6.5 million already received under the agreement for development activities up to the completion of IND-enabling studies.
In the meantime, Redx is still eligible for research, regulatory, and commercial milestone payments, as well as incremental tiered royalties depending on future net sales.
JZP815 has a distinct mode of action, and Jazz plans to evaluate it as a treatment for a variety of hard-to-treat solid tumours with high unmet patient needs. JZP815 is expected to start a phase 1 clinical trial in the near future, and when it does, it will be the fifth Redx drug to reach the clinic.
Redx's CEO, Lisa Anson, gushed: "I am overjoyed that the IND application for JZP815, a pan-RAF inhibitor, has been approved. Redx's Jazz will be the fifth medication candidate discovered by Redx to enter the clinic when it begins its clinical trial, demonstrating our world-class research and development capabilities. We respect our great partnership with Jazz Pharmaceuticals and look forward to continuing to collaborate with them."
Jazz Pharmaceuticals' Executive Vice President, Rob Iannone, added: "We're excited to start a clinical development for JZP815, a precision pan-RAF inhibitor with a distinct mode of action. JZP815 could be a game-changer in the pan-RAF inhibitor family because it doesn't cause paradoxical pathway activation, which can promote cancer growth."
A separate partnership agreement exists between Jazz and Redx to discover and develop pharmaceutical candidates in the RAS-RAF-MAP kinase pathway.
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