UK-based biotechnology firm Redx Pharma has received a recommendation from a safety review committee to continue the evaluation of its cancer asset, RXC004, in an ongoing Phase I/II clinical trial.
The company has completed dosing of the first cohort with 0.5mg of RXC004 and the corresponding results were reviewed by the committee, which said that the dose can be escalated.
Redx has now started patient recruitment for the study’s second cohort involving a higher pre-specified dose.
RXC004 is an oral small molecule porcupine inhibitor designed to target the Wnt signalling pathway.
Porcupine is a drug target on the Wnt pathway that is believed to be associated with the maintenance of stem cells in different cancers.
The company added that the Wnt pathway is involved in tumorigenesis, metastasis, recurrence, and resistance in cancer.
Following the Phase I monotherapy trial, RXC004 is expected to help in treating a variety of cancers in multiple settings. The candidate acts as an immuno-oncology agent and also directly targets tumours in patients with upstream Wnt signalling pathway alterations.
The Phase I monotherapy dose-escalation study is set to be completed in the first half of next year.
It is a multi-arm, multi-part adaptive design trial intended to assess the safety and tolerability of RXC004 in a total of 50 patients with advanced malignancies.
Dose-escalation will be carried out until the maximum tolerated dose or anti-tumour effects are obtained.
Redx Pharma CEO Lisa Anson said: “We are pleased that the safety review committee has recommended that we can now escalate the dose in the Phase I/II study of RXC004, our oral porcupine inhibitor, and consequently we have begun enrolment of our second cohort of patients as per protocol.
“We believe that RXC004 has the potential to offer clinical benefit both as a monotherapy and in combination with standard of care treatments for patients with Wnt-driven advanced solid tumours.”
Redx stopped enrolment for the Phase I/II trial in March last year after clinically significant RXC004-related adverse events were found in the first treated participant.
The study was re-started in January this year following the UK’s Medicines and Healthcare Regulatory Agency (MHRA) approval of a revised protocol and drug formulation.