REG - Redx Pharma plc - Clinical Trial Agreement with MSD

Redx PharmaAnnouncement

16/12/2022 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20221216:nRSP9133Ja&default-theme=true

RNS Number : 9133J  Redx Pharma plc  16 December 2022

 REDX PHARMA PLC

("Redx" or the "Company")

 

Redx Signs Clinical Trial Collaboration and Supply Agreement with MSD to
evaluate RXC004 in combination with KEYTRUDA® (pembrolizumab) in PORCUPINE2
Study in Biliary Cancer

 

 

Alderley Park, UK, 16 December 2022 Redx (AIM:REDX), the clinical-stage
biotechnology company focused on discovering and developing novel, small
molecule, highly targeted therapeutics for the treatment of cancer and
fibrotic disease, announces that the Company has entered into a clinical trial
collaboration and supply agreement with MSD (Merck & Co., Inc.,  Rahway,
NJ, USA), for the supply of KEYTRUDA® (pembrolizumab), MSD's anti-PD-1
therapy, to be used in the combination arm of Redx's ongoing PORCUPINE2 Phase
2 clinical study evaluating RXC004 as a potential treatment for patients with
biliary cancer.

 

RXC004, Redx's lead oncology asset, is being developed as a targeted treatment
for Wnt-ligand dependent tumours. It is a potent, selective, oral,
small-molecule inhibitor of the Porcupine enzyme, a key activator of
Wnt-ligands in the Wnt signalling pathway. RXC004 is being investigated both
as a monotherapy treatment and in combination, where RXC004 will be combined
with immune checkpoint inhibitors (ICIs).

 

Biliary cancer is known to be heavily reliant upon Wnt signalling, with over
70%(( 1 )) of biliary cancer patients showing high Wnt-ligand expression,
potentially making this indication highly sensitive to the benefits of
Porcupine inhibition. Tumour-derived Wnt-ligand signalling is implicated in
reduced intrinsic and adaptive resistance to ICI therapy in multiple
cancers(( 2 ))(( 3 ))(( 4 )). Inhibition of Wnt-ligand signalling can enhance
ICI efficacy by reversing dendritic cell tolerisation, decreasing Treg cells,
and reducing the recruitment of myeloid-derived suppressor cells(( 5 )). It
has been shown that RXC004 can reverse immune evasion in mouse tumour models
and therefore there may be an additive benefit when given in combination with
ICI therapies 6  such as pembrolizumab.

 

Professor Juan Valle, Professor and Honorary Consultant in Medical Oncology,
University of Manchester & The Christie NHS Foundation Trust and RXC004
PORCUPINE2 Chief Investigator commented: "Currently, advanced biliary cancer
has only a 2% 5-year survival rate, with a critical unmet need for additional
treatment options. It is important to study agents such as the Porcupine
inhibitor RXC004, which may sensitise some types of tumours to ICI therapies,
in an effort to find effective treatment combinations that may improve
outcomes for these patients, who have a particularly poor prognosis."

 

Dr Jane Robertson, Chief Medical Officer, Redx Pharma commented: "We are
delighted to enter into a collaboration agreement with MSD for our ongoing
PORCUPINE2 study to evaluate RXC004 in combination with their anti-PD-1
therapy, pembrolizumab. Biliary cancer is a devastating disease that is
heavily reliant on Wnt signalling, so we are keen to explore the potential of
combining RXC004 with ICIs. Our hypothesis, based on the preclinical data we
have generated, is that when combined, there may be a greater chance of the
patients showing an immune response, which we hope will lead to improved
outcomes."

 

About the RXC004 Phase 2 Clinical Trial Programme

RXC004 entered Phase 2 clinical trials in November 2021. The first study in
the Phase 2 programme, PORCUPINE, (clinicaltrials.gov NCT04907539) is focused
on patients with advanced microsatellite stable metastatic colorectal cancer
(MSS mCRC) who have progressed following treatment with standard of care and
is evaluating preliminary efficacy and safety of RXC004 in genetically
selected patients with Ring finger protein 43 (RNF43) or R-spondin (RSPO)
aberrated, advanced MSS mCRC. A second Phase 2 study of RXC004, PORCUPINE2,
(clinicaltrials.gov NCT04907851), as a monotherapy for genetically selected
pancreatic cancer and biliary cancer, a highly Wnt-ligand dependent cancer,
commenced in January 2022.

 

Given the dual mechanism of action of RXC004, which preclinically was shown to
inhibit tumour growth and immune evasion, there is a strong rationale for
immune therapy combination. In November 2022, Phase 1 clinical data evaluating
the safety and tolerability of RXC004 in combination with nivolumab, in
patients with advanced malignancies was presented as a poster at the Society
of Immunotherapy of Cancer (SITC) Conference.  The data was suggestive of an
anti-tumour immune response, which is reported to correlate with an improved
response to PD-1 immune checkpoint inhibitors. The results of the study
supported a dose selection of 1.5mg once daily to be used in combination
modules of both PORCUPINE and PORCUPINE2.

 

The combination module of the PORCUPINE trial will evaluate RXC004 in
combination with nivolumab, (OPDIVO® - Bristol Myers Squibb, a PD-1
inhibitor) and this module is now approved by the FDA, which will allow
patient recruitment to commence in US trial centres. The second module of the
PORCUPINE2 study, (clinicaltrials.gov NCT04907851), will evaluate RXC004 in
combination with pembrolizumab (KEYTRUDA® - MSD's anti-PD-1 therapy) in
biliary cancer. Redx expects to report topline data readouts from the Phase 2
programme starting in the first half of 2023.

 

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a
subsidiary of Merck & Co., Inc., Rahway, NJ, U.S.A.

 1  Loilome et al. 2014, Boulter et al. 2015

 2  Spranger and Gajewski 2018 Nat Rev Cancer. 18(3): 139-147

 3  Rodriguez et al 2018 Rodriguez-Pascual et al . Cancer Drug Resist
2019;2:980-93

 4  Luke et al 2019, Clin. Cancer Res. 25(10):3074-3083

 5  Devito et al, 2021 Cell Reports 35, 109071, May 4, 2021

 6  Phillips et al, 2022, Cancer Res Commun. 2(9):914-928.

 

 For further information, please contact:

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

 UK Headquarters

 Caitlin Pearson, Head of Communications

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

 Lisa Anson, Chief Executive Officer

 Peter Collum, Chief Financial Officer (US Office)

 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

 

 

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, being developed as
a targeted treatment for Wnt-dependent cancers, commenced a Phase 2 programme
in November 2021. The Company's lead fibrosis product candidate, the
selective ROCK2 inhibitor RXC007, is in development for interstitial lung
disease and commenced a Phase 2a trial for idiopathic pulmonary fibrosis (IPF)
in October 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 AZD5055/RXC006, a Porcupine inhibitor
targeting fibrotic diseases including IPF, which AstraZeneca is progressing in
a Phase 1 clinical study. In addition, Redx has forged collaborations with
Jazz Pharmaceuticals, which includes JZP815, a pan-RAF inhibitor developed by
Redx which Jazz is now progressing through Phase 1 clinical studies, and an
early stage oncology research collaboration.

 

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

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  AGREAXASFSNAFFA