Topline data from Phase II monotherapy module

Redx, a clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, has shared topline monotherapy data from the biliary tract cancer (BTC) module of the RXC004 PORCUPINE2 Phase II clinical trial programme.

RXC004 is an orally active, once daily, porcupine inhibitor being developed as a targeted treatment for Wnt-ligand dependent cancers. The objective of the Phase II programme is to provide an initial assessment of the efficacy and safety of the drug both as a single agent and in combination with anti-PD-1 therapy, in patients with certain Wnt-ligand dependent solid tumours whose cancers have progressed following standard of care therapies.

The RXC004 Phase II clinical development programme consists of two studies, PORCUPINE and PORCUPINE2, which are detailed below.

The data announced is the first from the Phase II programme, and are from 16 previously treated patients enrolled in the advanced BTC monotherapy arm of the PORCUPINE2 study. The primary endpoint was Progression Free Survival at six months.

Some patients received durable clinical benefit from RXC004 in this cohort, consistent with clinical activity seen in the Phase I trial, and the safety profile of RXC004 in this module was also consistent with the safety data previously reported in the Phase I trial. However, the overall results are not sufficient to support the further development of RXC004 as a monotherapy in this treatment setting.

Looking forward

Planned retrospective analysis of all efficacy and biomarker data in this BTC monotherapy cohort will increase the understanding of the single agent activity of RXC004 and will be used to aid interpretation of the ongoing combination module efficacy, where RXC004 is used alongside anti-PD-1 therapy, pembrolizumab.

“Our Phase II programme is designed to explore the activity of RXC004 both as monotherapy and in combination with immune checkpoint inhibitors, consistent with its postulated dual mechanism of action. Our primary efficacy hypothesis is that in combination it can overcome immune evasion and anti-PD-1 resistance, which could open new patient segments,” said Dr Jane Robertson, Chief Medical Officer, Redx Pharma. “While today’s results do not support further clinical development of RXC004 as monotherapy in recurrent BTC, where very few drugs have received regulatory approval as single agents in this hard-to-treat disease, they are nonetheless consistent with the overall hypothesis that RXC004 has potential as an active component of combination therapy. We look forward to the data read out from the combination module with pembrolizumab that is expected in the second half of this year.”

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