REDX.L Regulatory News (REDX)

REDX PHARMA PLC

("Redx" or the "Company")

Redx Pharma Announces Milestone Payment from Jazz Pharmaceuticals

Milestone payment triggered by initiation of IND-enabling studies in Pan-RAF inhibitor programme

Pan-RAF programme is one of three partnership deals that Redx has consummated in addition to developing the company's wholly owned products in clinical development

Alderley Park, 2 September 2021 Redx Pharma plc (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, announced 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. Mutations leading to uncontrolled signalling in the RAS-RAF-MAPK pathway are seen in around one third of all cancers.

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-RAFV600E/K mutant skin cancers are initially sensitive to approved B-RAF selective drugs, treatment resistance often develops leading to disease progression. Moreover, B-RAFV600E 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."

About Redx Pharma Plc 

Redx Pharma (AIM:REDX) is focused on the discovery and development of novel targeted medicines for the treatment of cancer and fibrotic diseases, aiming initially to progress them to clinical proof of concept, before evaluating options for further development and potential value creation. Redx's lead oncology asset, the Porcupine inhibitor RXC004, is expected to commence a Phase 2 programme in H2 2021. The Company's selective ROCK2 inhibitor, RXC007, is in development for idiopathic pulmonary fibrosis and commenced a Phase 1 clinical study in June 2021 for which results are expected in 2022.

The Company has a strong track record of discovering new drug candidates through its core capability of converting medicinal chemistry insights into differentiated and commercially attractive drug candidates, with five proprietary or partnered assets in late pre-clinical or clinical development. One of those assets, a BTK inhibitor - pirtobrutinib/LOXO 305 - was sold to Loxo Oncology (now Eli Lilly) and is currently in Phase 3 clinical studies in chronic lymphocytic leukaemia. In addition, Redx has forged pre-clinical asset partnerships with other blue chip companies including AstraZeneca and Jazz Pharmaceuticals.

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