REDX.L Regulatory News (REDX)

REDX PHARMA PLC

("Redx" or "the Company")

Redx Presents Poster on Phase 2 Clinical Trial of RXC004 'PORCUPINE' at the American Society of Clinical Oncology (ASCO) Annual Meeting

Alderley Park, 30 May 2022, Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, announces that a poster abstract on RXC004 at the American Society of Clinical Oncology (ASCO) Annual Meeting (3-7 June 2022, Chicago, US/virtual) is now available for viewing. A formal presentation of the poster by the Chief Investigator, Professor Scott Kopetz, The University of Texas MD Anderson Cancer Center, Houston, TX., will be made at the conference on 4 June 2022.

RXC004, a highly potent and selective, orally active once-daily Porcupine inhibitor, is being developed as a targeted therapy for Wnt-ligand driven cancer. It is currently being evaluated as monotherapy in Phase 2 proof-of-concept clinical trials in genetically selected patients with metastatic colorectal cancer and pancreatic cancer, as well as in unselected patients with biliary cancer. Additionally, RXC004 is in a Phase 1 combination study with nivolumab, an anti-PD-1 antibody from which a dose for the combination arm of the Phase 2 colorectal cancer study will be selected later this year. Data readouts from these Phase 2 studies are expected in 2023.

The poster entitled 'A Multi-arm, Phase 2, Open-Label Study to Assess the Efficacy of RXC004 as Monotherapy and in Combination with Nivolumab, in Patients with Ring Finger Protein 43 (RNF43) or R-Spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable Colorectal Cancer, following standard treatment' details the design of Redx's ongoing PORCUPINE1 Phase 2 trial of RXC004 monotherapy, and RXC004 in combination with nivolumab, an anti-PD-1 antibody, in patients with advanced microsatellite stable (MSS) metastatic colorectal cancer (mCRC) who have progressed following treatment with standard of care. The PORCUPINE trial will explore the dual mechanism of action of RXC004 seen in the preclinical models by targeting tumour cells and reversing immune evasion.

Dr Jane Robertson, Chief Medical Officer, Redx Pharma, said: "We continue to be excited by the potential of RXC004 to tackle a number of Wnt-ligand driven cancers with high unmet clinical need, including metastatic colorectal cancer. We look forward to progressing our proof-of-concept Phase 2 studies with this compound, where we expect to report headline data during 2023."

More information on the contents of the poster

The abstract is available on the ASCO website at: http://ASCO.org/abstracts and the poster will be made available Company's website following the presentationat: https://www.redxpharma.com/scientific-publications/. The poster describes the ongoing PORCUPINE study, which is currently open in the USA, UK, Spain and South Korea. The PORCUPINE study initially opened with the monotherapy arm (Arm A), whilst the combination arm (Arm B) will be opened once a dose for RXC004 in combination with nivolumab has been established in the combination module of the Phase 1 study. To be eligible for this study, patients must have metastatic microsatellite stable colorectal cancer with a loss of function RNF43 mutation or an RSPO 2/3 fusion, which has progressed following standard therapies.

1 ClinicalTrials.gov Identifier: NCT03447470

About RXC004

RXC004, a highly potent and selective, orally active once-daily Porcupine inhibitor is being developed as a targeted therapy for Wnt-ligand driven cancer. 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 (ICIs) such as nivolumab. RXC004 has the potential to both directly inhibit the tumour growth and have an immune-enhancing effect in 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.

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. Redx 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 a clinical-stage biotechnology company focused on the discovery and development of novel, small molecule, highly targeted therapeutics 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 product candidate, the Porcupine inhibitor RXC004, commenced a Phase 2 programme in November 2021. The Company's selective ROCK2 inhibitor product candidate, RXC007, is in development for idiopathic pulmonary fibrosis and commenced a Phase 1 clinical trial in June 2021. Encouraging safety and pharmacokinetic data has been reported, and a Phase 2 clinical program is confirmed to start in 2022. Redx's third drug candidate, RXC008, a GI-targeted ROCK inhibitor for the treatment of fibrostenotic Crohn's disease, is currently in pre-IND stage, with Phase 1 clinical studies expected to commence in 2023. 

The Company has a strong track record of discovering new drug candidates through its core strengths in medicinal chemistry and translational science, enabling the Company to discover and develop differentiated therapeutics against biologically or clinically validated targets. The Company's accomplishments are evidenced not only by its two wholly-owned clinical-stage product candidates and rapidly expanding pipeline, but also by its strategic transactions, including the sale of pirtobrutinib (RXC005, LOXO-305), a BTK inhibitor now in Phase 3 clinical development by Eli Lilly following its acquisition of Loxo Oncology and RXC006, a Porcupine inhibitor targeting fibrotic diseases including idiopathic pulmonary fibrosis (IPF), which AstraZeneca is progressing in a Phase 1 clinical study. In addition, Redx has forged collaborations with Jazz Pharmaceuticals.

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