REG - Redx Pharma plc - Pan-RAF Inhibitor to Enter Clinical Development

Redx PharmaAnnouncement

15/06/2022 07:00

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RNS Number : 8905O  Redx Pharma plc  15 June 2022

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION IN RESPECT OF REDX PHARMA PLC
FOR THE PURPOSES OF ARTICLE 7 OF EU REGULATION 596/2014 AS IT FORMS PART OF
DOMESTIC LAW IN THE UNITED KINGDOM BY VIRTUE OF THE EUROPEAN UNION
(WITHDRAWAL) ACT 2018.

 

REDX PHARMA PLC ("Redx") AND JAZZ PHARMACEUTICALS PLC ("Jazz")

 

Jazz Pharmaceuticals and Redx Announce Pan-RAF Inhibitor JZP815 to Enter
Clinical Development

 

Clearance of IND application for JZP815 marks fifth Redx product candidate to
enter clinical development and triggers USD $5 million milestone payment from
Jazz

 

Jazz to initiate clinical development of JZP815 as a drug candidate for
several types of difficult-to-treat solid tumours

 

Dublin and Alderley Park, 15 June 2022, Jazz Pharmaceuticals (NASDAQ: JAZZ)
and Redx (AIM: REDX) announce the U.S. Food and Drug Administration (FDA) has
cleared the Investigational New Drug (IND) application for JZP815, a pan-RAF
inhibitor for the treatment of solid tumors and hematologic malignancies that
contain mutations in the MAPK pathway, enabling Jazz to proceed with
initiating a clinical trial for JZP815. As a result, a milestone payment of
USD $5 million from Jazz payable to Redx has been triggered.

 

The milestone payment was triggered under the Agreement in which Jazz acquired
Redx's pan-RAF inhibitor programme, announced on 10 July 2019. Redx carried
out development activities up to the completion of IND-enabling studies.
Today's milestone is on top of USD $6.5 million already received under the
collaboration and Redx remains entitled to development, regulatory and
commercial milestone payments as well as incremental tiered royalties in
mid-single digit percentages, based on any future net sales.

 

Preclinical data from this pan-RAF programme was recently presented at the
American Association for Cancer Research (AACR) conference in March. JZP815 is
a precision pan-RAF inhibitor with a differentiated mechanism of action, and
Jazz expects to assess its utility in treating several types of
difficult-to-treat solid tumours where there remains 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, Chief Executive Officer of Redx, commented: "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, M.D., M.S.C.E., Executive Vice President, Global Head of Research
and Development of Jazz Pharmaceuticals, commented: "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. 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. Redx has an exceptional team of research and development
scientists and together we have formed an outstanding collaboration,
leveraging the strengths of both companies."

 

Jazz and Redx also have a separate collaboration agreement to discover and
develop drug candidates in the RAS-RAF-MAP kinase (MAPK) pathway, where Redx
is again responsible for research and preclinical development activities up to
IND application to the FDA.

 

About Pan-RAF inhibitors

Mutations leading to uncontrolled signalling in the RAS-RAF-MAPK pathway are
seen in around one third of all cancers. The Company's 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 compensatory functions of other RAF family members. Importantly, B-RAF
selective therapies fail to show clinical benefit against the more prevalent
RAS-mutated tumours.

 

About JZP815

JZP815 is an investigational, pre-clinical stage pan-RAF kinase inhibitor that
was discovered and developed using state-of-the-art screening methodologies
and medicinal chemistry. JZP815 targets specific components of the
mitogen-activated protein kinase (MAPK) pathway that, when activated by
oncogenic mutations, can be a frequent driver of human cancer. JZP815 potently
inhibits both monomer- and dimer-driven RAF signaling (e.g., RAS-induced),
prevents paradoxical pathway activation induced by BRAF selective inhibition,
and is active against class 1, class 2, and class 3 BRAF mutants, as well as
BRAF fusions and CRAF mutants. JZP815 is not currently approved for use
anywhere in the world. JZP815 is part of Jazz's growing early-stage R&D
pipeline focused on solid tumours and targeted therapy.

 

About Redx Pharma Plc

Redx Pharma (AIM: REDX) is a clinical-stage biotechnology company focused on
the discovery and development of novel, small molecule, highly targeted
therapeutics 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 product candidate, the Porcupine inhibitor RXC004, commenced a Phase
2 programme in November 2021. The Company's selective ROCK2 inhibitor product
candidate, RXC007, is in development for idiopathic pulmonary fibrosis and
commenced a Phase 1 clinical trial in June 2021. Encouraging safety and
pharmacokinetic data has been reported, and a Phase 2 clinical programme is
confirmed to start in 2022. Redx's third drug candidate, RXC008, a GI-targeted
ROCK inhibitor for the treatment of fibrostenotic Crohn's disease, is
currently in pre-IND stage, with Phase 1 clinical studies expected to commence
in 2023.

 

The Company has a strong track record of discovering new drug candidates
through its core strengths in medicinal chemistry and translational science,
enabling the Company to discover and develop differentiated therapeutics
against biologically or clinically validated targets. The Company's
accomplishments are evidenced not only by its two wholly-owned clinical-stage
product candidates and rapidly expanding pipeline, but also by its strategic
transactions, including the sale of pirtobrutinib (RXC005, LOXO-305), a BTK
inhibitor now in Phase 3 clinical development by Eli Lilly following its
acquisition of Loxo Oncology and RXC006, a Porcupine inhibitor targeting
fibrotic diseases including idiopathic pulmonary fibrosis (IPF), which
AstraZeneca is progressing in a Phase 1 clinical study. In addition, Redx has
forged collaborations with Jazz Pharmaceuticals with IND clearance for JZP815
and a further oncology programme in early stage research.

 

To subscribe to Email Alerts from Redx, please visit:
www.redxpharma.com/investor-centre/email-alerts/

 

About Jazz Pharmaceuticals plc

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharmaceutical company
whose purpose is to innovate to transform the lives of patients and their
families. We are dedicated to developing life-changing medicines for people
with serious diseases -often with limited or no therapeutic options. We have a
diverse portfolio of marketed medicines and novel product candidates, from
early-to late-stage development, in neuroscience and oncology. Within these
therapeutic areas, we are identifying new options for patients by actively
exploring small molecules and biologics, and through innovative delivery
technologies and cannabinoid science. Jazz is headquartered in Dublin,
Ireland and has employees around the globe, serving patients in nearly 75
countries. For more information, please visit www.jazzpharmaceuticals.com
(https://c212.net/c/link/?t=0&l=en&o=3557549-1&h=2984545271&u=http%3A%2F%2Fwww.jazzpharmaceuticals.com%2F&a=www.jazzpharmaceuticals.com)
 and follow @JazzPharma on Twitter.

 

The person responsible for the release of this announcement on behalf of Redx
is Andrew Booth, Company Secretary.

 

 

 For further information, please contact:

 Redx Pharma Plc                                                                               T: +44 (0)1625 469 918

 Caitlin Pearson, Head of Communications

 ir@redxpharma.com (mailto:ir@redxpharma.com)

 UK Headquarters

 Lisa Anson, Chief Executive Officer

 US Office

 Peter Collum, Chief Financial Officer

 SPARK Advisory Partners (Nominated Adviser)                                                   T: +44 (0)203 368 3550
 Matt Davis/ Adam Dawes

 WG Partners LLP (Joint Broker)                                                                T: +44 (0)203 705 9330
 Claes Spång/ Satheesh Nadarajah/ David Wilson

 Panmure Gordon (UK) Limited (Joint Broker)                                                    T: +44 (0)207 886 2500
 Rupert Dearden/ Freddy Crossley/ Emma Earl

 FTI Consulting                                                                                T: +44 (0)203 727 1000
 Simon Conway/ Ciara Martin

 Jazz Media Contact:
 Kristin Bhavnani

 Head of Global Corporate Communications

 Jazz Pharmaceuticals plc

 CorporateAffairsMediaInfo@jazzpharma.com
 (mailto:CorporateAffairsMediaInfo@jazzpharma.com)

 Ireland +353 1 637 2141

 U.S. +1 215 867 4948

 Jazz Investor Contact:

 Andrea N. Flynn, Ph.D.

 Vice President, Head, Investor Relations

 Jazz Pharmaceuticals plc

 InvestorInfo@jazzpharma.com (mailto:investorinfo@jazzpharma.com)

 Ireland +353 1 634 3211

 U.S. +1 650 496 2717

 

 

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