TIDMREDX
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 PORCUPINE 2 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 r etrospective 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 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 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(R) - 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 NCT04907851), will evaluate RXC004 in
combination with pembrolizumab, (KEYTRUDA(R) - 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
(R), 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
Lisa Anson, Chief Executive Officer
US Office
Peter Collum, Chief Financial
Officer
SPARK Advisory Partners (Nominated T: +44 (0)203 368 3550
Adviser)
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 T: +44 (0)207 886 2500
Broker)
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.
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1 Incidence data sourced from GlobalData Epidemiology data
(Major Markets: US, EU5, Japan, China)
2 www.cancer.net
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