TIDMREDX
RNS Number : 3634M
Redx Pharma plc
20 September 2021
REDX PHARMA PLC
("Redx" or the "Company")
Redx Presents Encouraging Phase 1 Data for its Porcupine
Inhibitor RXC004 in Patients with Advanced Solid Tumours
Clinical activity differentiated in tumours with Wnt-ligand
dependence
Data presented at ESMO supports monotherapy Phase 2 start in H2
2021
Company to host R&D event on 11 October 2021
Alderley Park, UK, 20 September 2021 - Redx Pharma (AIM: REDX),
the drug discovery and development company focused on cancer and
fibrosis, today announces data from the monotherapy module of its
Phase 1 clinical study of RXC004 for the first time. The data was
presented at the European Society for Medical Oncology (ESMO)
Congress 2021 by the study's lead investigator, Dr Natalie Cook,
from the University of Manchester and Christie NHS Foundation
Trust.
The Phase 1 trial (clinicaltrials.gov NCT03447470) is evaluating
RXC004, a wholly owned small-molecule Porcupine inhibitor as a
monotherapy (Module 1) and in combination with nivolumab (Module 2)
in unselected patients with advanced solid tumours for whom no
standard therapy is available. The primary objective of the open
label, '3+3' dose escalation Phase 1 study is to assess the safety
and tolerability of RXC004 with secondary endpoints including
pharmacokinetics (PK) and anti-tumour activity, as measured by
Response Evaluation Criteria in Solid Tumours (RECIST 1.1). The
data presented are from 25 patients in the completed monotherapy
module of the trial and informed the selection of 2mg as the dose
for the planned Phase 2 monotherapy trials testing RXC004 in three
different Wnt-ligand dependent cancers.
Dr Natalie Cook, Lead Investigator of the Study, from the
University of Manchester and Christie NHS Trust, commented: "This
Phase 1 study provides encouraging evidence of the potential of
Porcupine inhibition as a targeted treatment approach and supports
the progression of RXC004 into Phase 2 development in selected
patients with Wnt-ligand driven cancers."
Lisa Anson, Chief Executive Officer of Redx Pharma, added: "The
first clinical data on our Porcupine inhibitor, presented at the
prestigious ESMO Congress, illustrate RXC004's potential to improve
outcomes in patients with Wnt-ligand driven advanced solid tumours
who have limited treatment options. RXC004 demonstrated a
well-tolerated profile at the selected dose and showed
differentiated signs of efficacy in Wnt-ligand dependent tumours.
We are excited to move to Phase 2 later this year, with a larger
number of patients with Wnt-ligand driven cancers, who represent
those most likely to benefit from treatment with RXC004."
Key results presented at ESMO highlighted:
-- RXC004 was safe and well tolerated as a single agent at doses
up to 2mg . No grade 4 or 5 adverse events (AEs) were reported at
these dose levels and the most common treatment-related AEs across
all patients were fatigue (52% of patients), nausea (44%),
decreased appetite (40%), dysgeusia ('altered taste') (40%) and
vomiting (24%). RXC004, given at doses up to 2mg alongside
denosumab prophylaxis, averted the bone toxicity traditionally
associated with Wnt-pathway inhibition, as evidenced by the absence
of both increases in the bone turnover marker <BETA> CTX and
spontaneous fractures.
-- An oral dose of 2mg once daily is selected as the Phase 2
dose of RXC004 in monotherapy . The 2mg once-daily dose
demonstrated high plasma exposure levels, while minimising adverse
events. RXC004 exposures were dose proportional and median
half-life was 14.5 hours. In addition, the pharmacodynamic marker
of Axin-2 levels in skin showed active target engagement.
-- Efficacy data supports further investigation of RXC004 use in
Wnt-ligand dependent tumours . Although the study was not designed
to assess efficacy as a primary endpoint, 18 patients had
RECIST-evaluable disease. Of these patients:
o 7 patients had Wnt-ligand dependent tumours, defined as those
having detectable ring-finger protein 43 (RNF43) Loss of Function
or R-spondin (RSPO) fusion, biliary-tract cancers or thymus
cancers; 6 patients had Wnt-ligand independent tumours, defined as
those having no detectable RNF43 Loss of Function or RSPO fusion,
or colorectal tumours with detectable downstream adenomatous
polyposis coli ( APC) mutations; 5 patients were of unknown
Wnt-ligand status.
o At the data cut-off date on 30 July 2021, 5 of 7 patients
(71%) with Wnt-ligand dependent tumours had durable RECIST stable
disease (SD) versus 0 of 11 (0%) patients with independent or
unknown Wnt-ligand status.
o Median treatment duration was 13.1 weeks (6.4 - 25.4 weeks)
for patients with Wnt-ligand dependent tumours versus 6.6 weeks
(5.4 - 7.3 weeks) for patients with either Wnt-ligand independent
tumours or tumours of unknown Wnt-ligand status.
The results from the second module in the Phase 1 study testing
RXC004 in combination with nivolumab (OPDIVO(R) - Bristol Myers
Squibb, an anti-PD-1 antibody) are expected in H2 2021 and will be
used to define a dose of RXC004 to be used in combination with
standard dose nivolumab in a Phase 2 study in patients with
genetically selected MSS mCRC.
A link to the presentation can be found here:
https://www.redxpharma.com/wp-content/uploads/2021/09/ESMO-Presentation-on-Redx-Website-1.pdf
Redx to host R&D Event
Today's data will be discussed by Medical Experts during Redx's
online R&D Event to be held on Monday 11 October 2021 at 1:00pm
BST / 8.00am EDT. The event will also cover the Company's pipeline
beyond RXC004.
To register for the event, please email
redxpharma@fticonsulting.com
About the Phase 2 programme for RXC004
Redx plans to commence a global Phase 2 monotherapy programme in
three tumour types to assess RXC004 efficacy in patients with
Wnt-ligand driven cancers. For patients with microsatellite stable
metastatic colorectal cancer (MSS mCRC) only those with RNF43
mutations or RSPO fusions will be enrolled. For pancreatic cancer
patients only those with RNF43 mutations will be enrolled. The
third tumour type to be studied will be biliary-tract cancer, a
tumour known to have high Wnt-ligand dependency which will enrol
unselected patients. All three of these cancer types have high
unmet need with limited treatment options and poor 5-year survival
rates of less than 3% for biliary and pancreatic cancer and 14% for
MSS mCRC. All three studies are planned to commence in H2 2021 and
initial results are expected in 2022.
For further information, please contact:
Redx Pharma Plc T: +44 1625 469
918
UK Headquarters
Lisa Anson, Chief Executive Officer
Karl Hård, Head of Investor Relations
US Office
Peter Collum, Chief Financial Officer
SPARK Advisory Partners (Nominated Adviser) T: +44 203 368
3550
Matt Davis/ Adam Dawes
WG Partners LLP (Joint Broker) T: +44 20 3705
9330
Claes Spång/ David Wilson
Panmure Gordon (UK) Limited (Joint Broker) T: +44 20 7886
2500
Rupert Dearden/ Freddy Crossley/ Emma Earl
FTI Consulting T: +44 20 3727
1000
Simon Conway/ Ciara Martin
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 tumours with 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
demonstrated preclinically 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 as a monotherapy or
combination therapy with ICIs.
About Redx Pharma Plc
Redx Pharma (AIM: REDX) is focused on the discovery and
development of novel targeted medicines 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
asset, the Porcupine inhibitor RXC004, is expected to commence a
Phase 2 programme in H2 2021. The Company's selective ROCK2
inhibitor, RXC007, is in development for idiopathic pulmonary
fibrosis and commenced a Phase 1 clinical study in June 2021 for
which results are expected in 2022.
The Company has a strong track record of discovering new drug
candidates through its core capability of converting medicinal
chemistry insights into differentiated and commercially attractive
drug candidates, with five proprietary or partnered assets in late
pre-clinical or clinical development. One of those assets, a BTK
inhibitor - pirtobrutinib/LOXO 305 - was sold to Loxo Oncology (now
Eli Lilly) and is currently in Phase 3 clinical studies in chronic
lymphocytic leukaemia. In addition, Redx has forged pre-clinical
asset partnerships with other blue chip companies including
AstraZeneca and Jazz Pharmaceuticals.
To subscribe to Email Alerts from Redx, please visit:
www.redxpharma.com/investor-centre/email-alerts/
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