Redx Pharma plc Redx Announces Phase 2 Dose Selection of RXC004 (5227G)
July 27 2021 - 2:00AM
UK Regulatory
TIDMREDX
RNS Number : 5227G
Redx Pharma plc
27 July 2021
REDX PHARMA PLC
("Redx" or the "Company")
Redx Pharma Announces Phase 2 Dose Selection of its Porcupine
Inhibitor, RXC004
Monotherapy Phase 2 Proof of Concept programme will evaluate
RXC004 in selected patients with three cancer types having high
Wnt-ligand dependency, with planned start H2 2021
Data from RXC004 monotherapy Phase 1 trial to be presented at
ESMO
Alderley Park, 27 July 2021 Redx Pharma (AIM: REDX), the drug
discovery and development company focused on cancer and fibrosis,
announces it has selected 2 mg once daily as the dose of RXC004 for
the planned Phase 2 monotherapy, proof of concept clinical trials
based on the safety profile observed in Phase 1. The studies are
expected to start during the second half of 2021. RXC004 is the
Company's lead drug candidate and is a highly potent, orally active
porcupine inhibitor being developed as a targeted therapy for
Wnt-ligand driven cancer. Porcupine is a key enzyme in the Wnt
pathway, well established as a key driver of both tumour growth and
immune evasion.
The selection of a dose and decision to move RXC004 into Phase
2, follows the successful recruitment of all patients to the
monotherapy arm of the Company's ongoing open label dose escalation
Phase 1 study (NCT03447470) . The primary objective of the Phase 1
study was to establish the safety and tolerability of RXC004 in
patients. Preliminary data from the study in patients with
unselected advanced solid tumours, showed that RXC004 2mg once
daily was safe, tolerated and provided target coverage at levels
required to assess monotherapy efficacy in Phase 2 clinical trials
in selected patients with Wnt-ligand driven cancers. Whilst the
Phase 1 study was in genetically unselected cancers, the data
suggested a differential level of activity between Wnt-ligand
driven cancers and non Wnt-ligand driven cancers, in line with
observations of other molecules in this class. Redx plans to
present the monotherapy results from the Phase 1 study at the ESMO
Congress in September 2021.
Lisa Anson, Chief Executive Officer of Redx Pharma commented
"Our Phase 1 monotherapy study supports our belief that RXC004 has
the potential to be a significant, novel targeted medicine for the
treatment of Wnt-ligand driven cancer. Our distinctive approach to
drug discovery has enabled our highly talented scientific team to
design our Porcupine Inhibitor to unlock the therapeutic potential
of Wnt pathway blockade, a long sought-after oncology target. The
decision to progress to Phase 2 and the selection of our
monotherapy dose represent major milestones in the clinical
development of our lead asset."
Jane Robertson, Chief Medical Officer of Redx Pharma added "The
Redx team and our investigators are excited to move forward into
Phase 2 clinical studies to evaluate the efficacy of RXC004 as
monotherapy in selected patients with mCRC, pancreatic and biliary
tract cancers, whose tumours have high Wnt-ligand dependency. We
look forward to initiating these studies in the coming months."
About the Phase 2 programme
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. In two tumour types, microsatellite stable
metastatic colorectal cancer (MSS mCRC) and pancreatic cancer, the
studies will enrol only patients whose tumours have high Wnt-ligand
dependency resulting from specific genetic aberrations (RNF43
mutations and/or RSPO fusions). A third proof of concept study will
enrol patients diagnosed with biliary tract cancer, a tumour known
to have high Wnt-ligand dependency. 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 mCRC. All three studies are planned to commence in H2
2021 and initial results could be available from 2022.
RXC004 is also currently being investigated in a Phase 1 study
in combination with nivolumab (OPDIVO(R) - Bristol Myers Squibb, an
anti-PD-1 antibody). The primary objective of this arm of the study
is to evaluate the safety and tolerability of this combination in
patients with unselected advanced malignancies. The results from
this combination study 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 microsatellite stable (MSS) metastatic colorectal cancer
(MSS mCRC).
For further information, please contact:
Redx Pharma Plc T: +44 1625 469
UK Headquarters Lisa Anson, Chief Executive 918
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/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 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. 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 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.
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 has been
linked 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.
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, 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 Redx 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. Redx has forged pre-clinical asset partnerships with
blue chip companies including AstraZeneca and Jazz
Pharmaceuticals.
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