Redx Pharma plc Dosing of first patients with RXC004 and Anti-PD1 (7852W)
28 April 2021 - 4:00PM
UK Regulatory
TIDMREDX
RNS Number : 7852W
Redx Pharma plc
28 April 2021
REDX PHARMA PLC
("Redx" or the "Company")
Redx Pharma Announces Dosing of first patients with Combination
of RXC004 and Anti-PD1
Alderley Park, 28 April 2021 Redx Pharma (AIM: REDX), the drug
discovery and development company focused on cancer and fibrosis,
announces that it has successfully initiated dosing of the first
patient cohort with a combination of RXC004, the Company's lead
drug candidate, and nivolumab (OPDIVO(R) - Bristol Myers Squibb, an
anti-PD-1 antibody). RXC004 is also currently being evaluated as
monotherapy in a Phase 1 clinical study, from which top line
results are expected by mid 2021.
The primary objective of the Phase 1 combination study is to
evaluate the safety and tolerability of RXC004 in combination with
nivolumab in patients with advanced malignancies
(ClinicalTrials.gov Identifier:NCT03447470). The announcement today
confirms that the first three patients have initiated treatment
with 1mg RXC004 along with nivolumab. The results from the
combination study are expected to read out 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 microsatellite stable (MSS) metastatic
colorectal cancer (MSS mCRC), which is planned to start to recruit
patients in H2 2021.
Lisa Anson, Chief Executive Officer of Redx Pharma said : "We
are delighted to have initiated dosing of our first patient cohort
in our Phase 1 RXC004 and anti-PD1 combination study. We believe
that RXC004 has the potential to offer clinical benefit both as a
monotherapy and in combination with immunotherapies for patients
with Wnt-driven advanced solid tumours.
"This important milestone opens our combination study programme,
which is an exciting addition to our ongoing Phase 1 monotherapy
study which is on track to report headline results by mid 2021"
What is RXC004?
RXC004 is a potent, selective, oral small molecule inhibitor of
the enzyme, porcupine, a key activator of Wnt ligands in the Wnt
signalling pathway. Aberrant Wnt signalling contributes directly to
tumour growth and plays an important role in immune evasion, which
leads to resistance to immune checkpoint inhibitors 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 attack the tumour.
Why are we testing anti-PD1 and RXC004 in combination?
Immune checkpoint inhibitors (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 could
contribute to lack of response to ICIs in these tumours. Our
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, which we are now testing in
clinical trials.
RXC004 Clinical trials
RXC004 is currently being investigated in a Phase 1 study, with
top line safety and tolerability data as a monotherapy expected by
mid 2021, with more detailed data expected to be presented at a
conference in H2 2021.
Following completion of the monotherapy Phase 1, clinical
proof-of concept monotherapy studies in genetically-selected
patients with metastatic colorectal cancer, genetically selected
pancreatic cancer and all comers biliary cancer are expected to
initiate. These studies are in addition to the combination study
programme
For further information, please contact:
Redx Pharma Plc T: +44 1625 469
918
Iain Ross, Chairman
Lisa Anson, Chief Executive
James Mead, 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/Nigel Birks/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 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 disease, aiming to progress them to clinical proof of
concept. Redx's lead oncology asset, RXC004, is currently in a
Phase 1 study in patients with advanced malignancies with top line
monotherapy data expected in H1 2021 and the Company's selective
ROCK2 inhibitor, RXC007, is expected to enter a Phase 1 clinical
study in H1 2021.
The Company's core capability of converting medicinal chemistry
insights into differentiated and commercially attractive small
molecule drug candidates against clinically validated targets has
been recognized by others. Over the last three years the company
has completed four major preclinical stage deals with AstraZeneca,
Jazz Pharmaceuticals and Loxo Oncology (now Eli Lilly).
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