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June 15, 2022

FDA grants IND clearance for Jazz and Redx’s cancer drug application

The clinical development has triggered a milestone payment of $5m payable by Jazz to Redx.

The US Food and Drug Administration (FDA) has granted clearance for the Investigational New Drug (IND) application of Jazz Pharmaceuticals and Redx’s JZP815 to treat solid tumours and hematologic malignancies with mutations in the MAPK pathway.

An investigational, pre-clinical stage drug candidate, JZP815 is a pan-RAF inhibitor.

It targets specific components of the mitogen-activated protein kinase (MAPK) pathway that on activation by oncogenic mutations can cause cancer.

With the regulatory clearance, Jazz will progress to commencing a clinical trial of JZP815 for various kinds of hard-to-treat solid tumours.

JZP815 will now become the fifth Redx-discovered compound to enter clinical trials.

Furthermore, the clinical development has triggered a milestone payment of $5m payable by Jazz to Redx. 

The milestone payment is in accordance with an agreement announced in July 2019, under which Jazz acquired Redx’s pan-RAF inhibitor programme.

Redx conducted the development activities until the conclusion of IND-enabling studies.

The milestone payment is in addition to $6.5m paid under the partnership.

Redx is also eligible to receive development, regulatory and commercial milestone payments and incremental tiered royalty payments based on any net product sales in the future.

Jazz Pharmaceuticals Research and Development global head and executive vice-president Rob Iannone said: “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.

“The JZP815 programme exemplifies our continued progress in expanding our early-stage oncology pipeline, and in developing therapies with the potential to address unmet patient need.”

Apart from this deal, the companies have a separate partnership for discovering and developing drug candidates in the RAS-RAF-MAP kinase pathway.

Under this deal, Redx will carry out research and preclinical development activities until IND application with the FDA.

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