TIDMREDX
RNS Number : 3112S
Redx Pharma plc
15 November 2021
REDX PHARMA PLC
("Redx" or the "Company")
Redx Announces First Patient Dosed in Phase 2 Clinical Trial of
RXC004 in Patients with Advanced Colorectal Cancer
First wholly-owned Redx asset to enter Phase 2 clinical
trial
Study will assess efficacy and safety of RXC004 in patients with
Wnt-ligand driven metastatic colorectal cancer
Alderley Park, UK, 15 November 2021 - Redx Pharma (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, today announces that
the first patient has been dosed in the monotherapy arm of the
Phase 2 clinical trial of its investigational drug RXC004 in
patients with advanced microsatellite stable (MSS) metastatic
colorectal cancer (mCRC) who have progressed following treatment
with standard of care. RXC004 is Redx's wholly-owned, highly potent
and selective, orally active once-daily Porcupine inhibitor being
developed as a targeted therapy for Wnt-ligand driven cancer.
The multi-centre Phase 2 clinical trial (clinicaltrials.gov
NCT04907539) will evaluate preliminary efficacy and safety of
RXC004 in genetically-selected patients with Ring finger protein 43
(RNF43) or R-spondin (RSPO) aberrated, advanced MSS mCRC. Topline
data is expected to report in the first half of 2023.
A second arm of the trial, evaluating RXC004 in combination with
the anti-PD-1 antibody nivolumab in patients with MSS mCRC, is
expected to commence in the first half of 2022 once a recommended
dose has been established in the ongoing Phase 1 dose escalation
combination trial.
Dr Natalie Cook, University of Manchester and Christie NHS
Foundation Trust, UK, and International Coordinating Investigator
of the study in the UK, commented: "Microsatellite stable
metastatic colorectal cancer is a devastating disease, with limited
treatment options. A subgroup of these colorectal cancers possess
RNF43 mutations or RSPO fusions leading to activation of the Wnt
pathway as a driver of the cancer. This study will assess whether
RXC004, a novel Porcupine inhibitor, has a clinically meaningful
anti-cancer effect in this well-defined patient cohort."
Lisa Anson, Chief Executive Officer of Redx Pharma, added: "We
are excited to be dosing patients in Redx's first ever Phase 2
clinical trial of a wholly-owned drug candidate, an important
corporate milestone. Our encouraging Phase 1 results, recently
reported at the ESMO Congress, combined with our preclinical data,
strongly support the hypothesis that patients with Wnt-ligand
driven tumours could benefit from RXC004."
A second Phase 2 clinical trial evaluating RXC004 as a
monotherapy in advanced genetically selected pancreatic cancer and
unselected biliary cancer is also expected to start in 2021.
For further information, please contact:
Redx Pharma Plc T: +44 (0)1625 469
918
UK Headquarters
Lisa Anson, Chief Executive Officer
Karl Hård, Head of Investor Relations
k.hard@redxpharma.com
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/ 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 microsatellite stable metastatic colorectal cancer (MSS
mCRC)
Metastatic colorectal cancers have a poor prognosis with a
5-year survival rate of approximately 15% (1). Standard first line
and second line treatments are combinations of chemotherapy and a
VEGF inhibitor or EGFR inhibitor. MSS cancers account for 95% of
metastatic CRC and tend to be unresponsive to treatment with immune
checkpoint inhibitors. In the third line treatment setting the
response rate to standard agents is <5%, median progression free
survival is approximately 2 months and overall survival
approximately 6 months (2,3). Approximately 8% of MSS mCRC patients
have Wnt-ligand driven tumours (3% RNF43 mutations and 5% RSPO
fusions) (4).
(1) https://seer.cancer.gov/statfacts/html/colorect.html
(2) Grothey A et al. Lancet 2013; 381(9863):303-12
(3) Mayer RJ, et al. N. Engl. J. Med. 2015; 372:1909-19
(4) https://www.cbioportal.org
About RXC004
RXC004 is a wholly owned, potent, selective, oral,
small-molecule inhibitor of the Porcupine enzyme, a key activator
of Wnt ligands in the Wnt-signalling pathway. The Wnt pathway is
well established as a driver of both tumour growth and immune
evasion. Aberrant Wnt signalling contributes directly to tumour
growth and plays an important role in immune evasion, which has
also been linked to resistance to immune-checkpoint inhibitors
(ICIs) such as nivolumab. By selecting patients with tumours that
have high Wnt-ligand dependency, such as those with loss of
function mutations in the RNF43 gene and fusions in the RSPO gene
family, RXC004 has an opportunity to both directly inhibit the
tumour growth and have an immune-enhancing effect to allow the
patient's immune system to better recognise and attack the
tumour.
ICIs such as anti-PD-1 antibodies have revolutionised the
treatment of cancer, but do not work in all patients. Wnt-pathway
activation can enhance the ability of the tumour to evade
destruction by the immune system and has been linked to lack of
response to ICIs in these tumours. Redx scientists have observed in
preclinical studies that RXC004 can block activation of the Wnt
pathway and restore the ability of the immune system to fight the
tumour. Thus, RXC004 offers potential to address some of the
shortcomings of ICI therapies through increasing both response
rates and duration of response, particularly in patient populations
unresponsive to ICI 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 disease, 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. Initial results were reported in October 2021, with full
Phase 1 results expected in 2022.
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 the two wholly-owned clinical-stage product candidates and
rapidly expanding pipeline, but also by the four strategic
transactions from which has emerged the most advanced product
candidate pirtobrutinib (RXC005, LOXO-305), a BTK inhibitor now in
Phase 3 clinical development by Eli Lilly following its acquisition
of Loxo Oncology. In addition, Redx has forged pre-clinical
collaborations with AstraZeneca and Jazz Pharmaceuticals.
Forward-Looking Statements
This press release contains forward-looking statements about our
business. Forward-looking statements are statements that are not
historical facts, and in some cases can be identified by terms such
as "may," "will," "could," "expects," "plans," "anticipates," and
"believes." These statements include, but are not limited to,
statements regarding the clinical development of RXC004, including
in respect of data to be reported therefrom and potential benefits
thereof to patients if approved. Any forward-looking statements are
based on management's current views and assumptions and involve
risks and uncertainties that could cause actual results,
performance or events to differ materially from those expressed or
implied in such statements, including suspensions, delays or other
developments in the Company's clinical trials and regulatory
developments. All information in this press release is as of the
date of the release, and the company undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events, or otherwise, except as required
by law.
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