REG - Redx Pharma plc - RXC004 Topline Data From a Phase 2 Module

Redx PharmaAnnouncement

08/03/2023 07:15

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RNS Number : 2221S  Redx Pharma plc  08 March 2023

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION 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" or "the Company")

 

Redx Announces RXC004 Topline Data From a Phase 2 Monotherapy Module

 

Overall efficacy results not sufficient to support further development as a
monotherapy in advanced biliary tract cancer patients.

 

Primary RXC004 efficacy hypothesis is to overcome immune evasion and enhance
the anti-tumour activity of immune checkpoint inhibitors; top-line data from
combination treatment modules expected in H2 2023.

Alderley Park, UK, 8 March 2023 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 topline monotherapy data from the biliary tract
cancer (BTC) module of the RXC004 PORCUPINE2 Phase 2 clinical trial programme.

 

RXC004 is an orally active, once daily, porcupine inhibitor being developed as
a targeted treatment for Wnt-ligand dependent cancers. The objective of the
Phase 2 programme is to provide an initial assessment of the efficacy and
safety of the drug both as a single agent and in combination with anti-PD-1
therapy, in patients with certain Wnt-ligand dependent solid tumours whose
cancers have progressed following standard of care therapies. The RXC004 Phase
2 clinical development programme consists of two studies, PORCUPINE and
PORCUPINE2, which are detailed below.

 

The data announced today, the first from the Phase 2 programme, are from 16
previously treated patients enrolled in the advanced BTC monotherapy arm of
the PORCUPINE2 study. The primary endpoint was Progression Free Survival at
six months. Some patients received durable clinical benefit from RXC004 in
this cohort, consistent with clinical activity seen in the Phase 1 trial, and
the safety profile of RXC004 in this module was also consistent with the
safety data previously reported in the Phase 1 trial. However, the overall
results are not sufficient to support the further development of RXC004 as a
monotherapy in this treatment setting.

 

Planned retrospective analysis of all efficacy and biomarker data in this BTC
monotherapy cohort will increase the understanding of the single agent
activity of RXC004 and will be used to aid interpretation of the ongoing
combination module efficacy, where RXC004 is used alongside anti-PD-1 therapy,
pembrolizumab.

 

"Our Phase 2 program is designed to explore the activity of RXC004 both as
monotherapy and in combination with immune checkpoint inhibitors, consistent
with its postulated dual mechanism of action. Our primary efficacy hypothesis
is that in combination it can overcome immune evasion and anti-PD-1
resistance, which could open new patient segments," said Dr Jane Robertson,
Chief Medical Officer, Redx Pharma. "While today's results do not support
further clinical development of RXC004 as monotherapy in recurrent BTC, where
very few drugs have received regulatory approval as single agents in this
hard-to-treat disease, they are nonetheless consistent with the overall
hypothesis that RXC004 has potential as an active component of combination
therapy. We look forward to the data read out from the combination module with
pembrolizumab, that is expected in the second half of this year."

 

Biliary tract cancer, a cancer with an annual incidence of 51,000 patients(1),
has an extremely poor prognosis, with only a 2% 5-year survival rate(2) and a
treatment response rate of less than 5% with standard second-line
chemotherapy.

 

About the RXC004 Phase 2 Clinical Trial Program

The first study in the Phase 2 programme, PORCUPINE, (clinicaltrials.gov
(http://clinicaltrials.gov/)  NCT04907539) is focused on patients with
advanced microsatellite stable metastatic colorectal cancer (MSS mCRC) that
has not 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
(http://clinicaltrials.gov/)  NCT04907851), for genetically selected
pancreatic cancer and biliary cancer, a highly Wnt-ligand dependent cancer is
also ongoing.

 

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 anti-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) in MSS mCRC and this module is now open for recruitment in all
countries taking part in the trial including the US and the UK. The
combination module of the PORCUPINE2 study, (clinicaltrials.gov
(http://clinicaltrials.gov/)  NCT04907851), will evaluate RXC004 in
combination with pembrolizumab, (KEYTRUDA® - MSD's anti-PD-1 therapy) in
biliary tract cancer. A clinical trial supply and collaboration agreement was
entered into with MSD (Merck & Co., Inc., Rahway, NJ, USA) in December
2022 for the supply of KEYTRUDA®, and this module is open for recruitment in
all countries taking part in this clinical trial including the UK and
Australia.

 

The person responsible for the release of this announcement on behalf of the
Company is Claire Solk, Company Secretary.

 

 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

 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

 

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 disease and the emerging
area of cancer-associated fibrosis, aiming initially to progress them to
clinical proof of concept before evaluating options for further development
and potential value creation. 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, with topline data expected in Q1 2024. Redx's lead oncology
product candidate, the Porcupine inhibitor RXC004, being developed as a
targeted treatment for Wnt-ligand dependent cancers, is expected to report
both monotherapy and combination with anti-PD-1 Phase 2 data during 2023.
Redx's third drug candidate, RXC008, a GI-targeted ROCK inhibitor for the
treatment of fibrostenotic Crohn's disease, is progressing towards a CTA/IND
application at the end of 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
non-covalent (reversible) BTK inhibitor now approved by the US FDA for adult
patients with mantle cell lymphoma previously treated with a covalent BTK
inhibitor, 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:
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(http://www.redxpharma.com/investor-centre/email-alerts/)

 

 

1 Incidence data sourced from GlobalData Epidemiology data (Major Markets: US,
EU5, Japan, China)

2 www.cancer.net

 

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