Redx Pharma Regulatory News (REDX)

REDX PHARMA PLC

("Redx" or "the Company")

Redx Presents Encouraging RXC004 Preclinical Data at the AACR Annual Meeting in Combination with Clinically Relevant Standard of Care Regimens

Alderley Park, 8 April 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 its poster at the American Association for Cancer Research (AACR) Annual Meeting (8-13 April, New Orleans) will be available for viewing from today. A formal presentation of the poster by the authors will be made at the conference on 12 April.

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 pancreatic cancer and metastatic colorectal cancer and 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 will be selected this year. Data readouts from the Phase 2 studies are expected in 2023.

The poster presented at the AACR meeting and entitled 'Pre-clinical efficacy of the Wnt pathway inhibitor RXC004 in combination with anti-cancer therapies' describes preclinical data which demonstrate that RXC004 in combination with clinically relevant standard of care chemotherapy regimens could lead to potential benefit, including survival, over chemotherapy alone. The poster hypothesised that the RXC004-induced downregulation of DNA repair pathway genes observed in vitro could contribute to the beneficial effect seen in combination with a PARP inhibitor in vitro as well as the combination effect observed in vivo with the standard of care chemotherapy agents.

Dr Jane Robertson, Chief Medical Officer, Redx Pharma, said: "This preclinical data further underpins our excitement around the therapeutic potential of RXC004, and the role of effective Wnt pathway blockade, in tackling a number of difficult to treat cancers with high unmet need."

More information on the contents of the poster

The presented poster, is available on the AACR e-poster website and the investor section of the Company's website at: https://www.redxpharma.com/investor-centre/presentations-analyst-reports-documents-and-videos/. It describes how RXC004 was evaluated in a mouse colorectal xenograft model alone and in combination with both the FOLFIRI* and FOLFIRINOX** treatment regimens, currently both standard of care chemotherapy in colorectal cancer. Efficacy was measured by tumour volume and survival endpoint. In addition, RXC004 was studied in vitro, as monotherapy and in combination with a PARP inhibitor in genetically selected cell lines with both RSPO-fusion and RNF43 mutation. Combination and monotherapy effects on proliferation and effects on downstream signalling were investigated.

* Folinic acid (FA), fluorouracil (5FU) and irinotecan.

** Folinic acid (FA), fluorouracil (5FU), irinotecan and oxaliplatin.

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. 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 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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