On September 2, 2021 Redx Pharma plc (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, reported that a milestone payment of $3 million from Jazz Pharmaceuticals plc (NASDAQ: JAZZ) has been triggered as a result of the initiation of IND-enabling studies of JZP815, a preclinical Pan-RAF inhibitor, for the potential treatment of RAF driven tumours (Press release, Redx Pharma, SEP 2, 2021, View Source [SID1234587167]). Mutations leading to uncontrolled signalling in the RAS-RAF-MAPK pathway are seen in around one third of all cancers.
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The milestone payment is due under the agreement with Jazz Pharmaceuticals announced on 10 July 2019 for Redx’s Pan-RAF inhibitor. Under the deal, Redx is entitled to up to $203 million in development, regulatory and commercial milestone payments. The Company is also eligible for royalties based on any future net sales. The next milestone payment under the agreement is due on acceptance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). As part of a separate ongoing collaboration agreement, Jazz paid Redx to perform research and preclinical development activities to progress the programme to this stage, with the goal of completing IND-enabling studies.
The Pan-RAF inhibitor programme aims to overcome resistance mechanisms associated with clinically approved B-RAF selective drugs. The RAF kinases A-RAF, B-RAF and C-RAF are an integral part of the RAS-RAF-MAPK pathway, with B-RAF mutations commonly seen in the clinic. Although most B-RAF V600E/K mutant skin cancers are initially sensitive to approved B-RAF selective drugs, treatment resistance often develops leading to disease progression. Moreover, B-RAF V600E mutant colorectal cancers are surprisingly insensitive to these B-RAF selective drugs as single agents due to the functions of other RAF family members. Importantly, B-RAF selective therapies fail to show clinical benefit against the more prevalent RAS-mutated tumours. This Pan-RAF inhibitor aims to overcome these resistance mechanisms.
Lisa Anson, Chief Executive Officer of Redx Pharma commented: "We are extremely pleased that Jazz Pharmaceuticals has initiated IND-enabling studies for the Pan-RAF inhibitor programme that Jazz acquired. The continuing success of this programme highlights, once again, Redx’s ability to generate molecules that have significant potential as novel medicines for unmet medical needs."