TIDMREDX
RNS Number : 6370Z
Redx Pharma plc
04 September 2018
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REDX PHARMA PLC
("Redx" or "the Company")
Redx Pharma Announces Way Forward For RXC004
Following MHRA agreement in principle, phase 1/2a Study expected
to restart at a significantly lower dose in H1'2019
Upon successful completion RXC004 to be studied as an
immuno-oncology agent in combination with immune checkpoint
inhibitors in solid tumours e.g. colorectal cancer
Alderley Park, 4 September 2018 Redx (AIM: REDX), the drug
development company focused on cancer and fibrosis, announces that
having presented an amended study protocol to the Medicines and
Healthcare products Regulatory Agency (MHRA, "the Agency"), the
Agency has agreed, in principle, with the proposed re-start of the
Company's phase 1/2a clinical study for the Porcupine inhibitor,
RXC004. Redx will now work with the investigators to finalise this
protocol, with the intention of restarting dosing of patients in
the first half of 2019.
Based on a thorough analysis of the data from the only patient
in the currently suspended trial, Redx, together with the study
investigators, believe that the desired systemic exposure, with the
potential for clinical benefit(1) , can now be achieved using a
significantly lower starting dose, with subsequent dose-escalation.
Following a positive meeting with the Company, the MHRA has agreed,
in principle, with this newly proposed starting dose and revised
protocol, including enhanced safety monitoring.
Porcupine is a recognized drug target on the Wnt cell signaling
pathway. There is now strong evidence that this pathway plays a key
role in how tumours avoid detection by the patient's own tumour
fighting immune cells, tumours of this type have been termed "cold"
tumours. Scientists at Redx have demonstrated the ability of RXC004
to enhance the host's immune system response to cancer in
preclinical models, turning these cold tumours into "hot" tumours.
The Company confirms it aims to position RXC004 as a potentially
attractive combination partner for immune-oncology agents e.g.
anti-PD1 (immune checkpoint inhibitors) in cancers where they
currently have clinical benefit in only a small percentage of
patients e.g. colorectal cancer.
Lisa Anson, Chief Executive Officer commented: "I am pleased to
announce that Redx has held a positive meeting with the MHRA in
which the Agency agreed, in principle, with a revised protocol for
restarting our previously suspended RXC004 phase 1/2a trial.
Importantly this new protocol includes a significantly lower
starting dose followed by carefully monitored dose-escalation. We
look forward to submitting our final protocol amendments, with the
aim of initiating the next patient in the first half of 2019. I
would like to thank my colleagues at Redx and our clinical
investigators for all their hard work that has resulted in our
Phase 1/2a proposal being positively received by the MHRA.
"I would also like to confirm that our aim at the next stage of
clinical testing will be to focus on RXC004 in combination with
immune-oncology agents in solid tumours e.g. colorectal cancer
patients."
Natalie Cook, Consultant Oncologist and Principal Investigator
from the Christie Hospital in Manchester commented: "We have learnt
a significant amount from the data of the first patient, and this
provides the basis for an optimised RXC004 development plan and
confidence to evaluate the clinical potential of RXC004 in cancer
patients."
RXC004 and the Clinical Programme
RXC004 is a novel, oral, potent small molecule Porcupine
inhibitor, which targets the Wnt pathway. The Wnt pathway is an
embryonic signalling pathway that is implicated in the maintenance
of cancer stem cells in multiple cancer types. This pathway is
associated with tumorigenesis, metastasis, recurrence and
resistance in cancer.
The first-in-man clinical trial for this drug is a modular,
multi-arm, multi-part, Phase 1/2a, adaptive design study whose
primary objective is to evaluate the safety and tolerability of the
drug in patients with advanced malignancies. It is anticipated that
a total c.50 patients will be enrolled. (ClinicalTrials.gov
Identifier: NCT03447470). In the first part of the study patients
are allocated to a dose and followed for a period of time for
potential dose limiting toxicities. Under the proposed amended
protocol patient dosing will be recommenced at 0.5mg as opposed to
the original starting dose of 10mg. Once this period is complete
the protocol dictates that the next arm of the study will be at a
higher dose until a maximum tolerated dose is reached.
As previously announced, Redx Pharma suspended recruitment of
patients to its phase 1/2a clinical study for RXC004 in March 2018
following dosing of the first patient. This was due to the
observation of clinically significant adverse events, which were
believed to be related to the on-target effects of RXC004 on the
inhibition of the Wnt pathway. Further analysis of clinical data
from this first patient indicates that their systemic RXC004
exposure was significantly higher than that predicted from
pre-clinical animal studies. While the maximum plasma concentration
of the drug (C(max) ) was in line with expectations, the terminal
half-life of the drug (t(1/2) ) was significantly longer than that
predicted from such animal models, due to the actual rate of
elimination being lower. The Company believes that higher drug
exposure in humans compared to pre-clinical studies is not uncommon
in the field of drug development. It typically arises from
differences between the metabolism observed in the animals used in
pre-clinical models on translating potential medicines into humans
for the first time.
On successful completion of this initial phase 1 monotherapy
study, RXC004 has the potential to be developed in two distinct
cancer treatment settings with major unmet medical need based on
two distinct mechanisms of action, as well as having pre-clinical
data suggesting an anti-fibrosis action.
Emerging data shows that Wnt is critical to the immune
environment and targeting the Wnt pathway is a recognised and
important mechanism to activate the immune system and may convert
immune "cold" tumours into immune "hot" tumours facilitating
response to immune-oncology agents. This may make RXC004 an
attractive combination partner for immune-oncology agents e.g.
anti-PD1 (immune checkpoint inhibitors) in cancers where they
currently have modest clinical benefit e.g. colorectal cancer.
Additionally, and separately, targeting tumours with specific
Wnt pathway alterations may offer clinical benefit on exploiting
RXC004 as both monotherapy, and in combination with standard of
care treatments, in tumours where such genetic alterations occur
most commonly e.g. Pancreatic, colorectal, gastric and
castrate-resistant prostate cancer.
For further information, please contact:
Redx Pharma Plc T: +44 1625 469
920
Lisa Anson, Chief Executive Officer
Andrew Saunders, Chief Medical Officer
Cantor Fitzgerald Europe (Nominated Advisor & T: +44 20 7894
Broker) 7000
Phil Davies
WG Partners LLP (Joint Broker) T: +44 20 3705
9330
Claes Spång/ Chris Lee/ David Wilson
FTI Consulting T: +44 20 3727
1000
Simon Conway/Stephanie Cuthbert
About Redx Pharma Plc
Redx is a UK biotechnology company whose shares are traded on
AIM (AIM:REDX). Redx's vision is to become a leading biotech
focused on the development of novel precision medicines that have
the potential to transform treatment in oncology and fibrotic
diseases.
If you would like to sign up to regular alerts from Redx Pharma,
please follow this link
https://www.redxpharma.com/investors/email-alerts/.
[1] The primary objective of the study remains the safety and
tolerability of the drug
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END
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