Redx Pharma Regulatory News (REDX)

REDX PHARMA PLC

("Redx" or "the Company")

Redx Presents Preclinical Efficacy Data for RXC007 Showing Significant Results in Cancer-Associated Fibrosis Models

Alderley Park, UK, 11 May 2023 Redx (AIM:REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, targeted therapeutics for the treatment of cancer and fibrotic disease announces additional preclinical data for its lead fibrosis asset, RXC007, and the Discodin Domain Receptor (DDR)1/2 discovery programme, as presented yesterday at the Resistant Tumour Microenvironment, Keystone Symposia, in Vancouver, BC. The data presented were from preclinical models of pancreatic ductal adenocarcinoma (PDAC) and triple negative breast cancer (TNBC), in combination with chemotherapy and immunotherapy, as current standard of care.

RXC007, in combination with gemcitabine/Abraxane®[i] in metastatic and high-extra cellular matrix (ECM) patient-derived PDAC models, was shown to increase survival compared to single agent standard of care alone. The combination of RXC007 with standard of care provided a significant increase in median survival days from date of treatment in a dose dependent manner. These new data on RXC007 complement those also presented at the meeting by collaboration partner the Garvan Institute of Medical Research ("the Garvan") on REDX10616, a close analogue of RXC007, which were also presented at the Extracellular Matrix Pharmacology congress last year. These data show REDX10616, in combination with FOLFIRINOX, re-sensitised a FOFIRINOX-resistant patient derived xenograft (PDX) model to treatment and led to a striking increase in survival in combination with the standard of care triplet chemotherapy.

Taken together, these data provide a strong rationale for the potential of ROCK2 inhibition in combination with standard of care as a potential treatment for cancer-associated fibrosis. Redx plans to further investigate this treatment setting with the Company's next-generation ROCK2 inhibitor, RXC007, in the clinic.

Additionally, at the Keystone Symposia, further data were also presented from Redx's DDR1/2 programme in combination with anti-PD-1 in TNBC models. Using a tool DDR1/2 inhibitor, in combination with anti-PD-1, in the TNBC E0771 model resulted in a statistically significant increase in survival when compared to the control group, an effect not observed with either single agent alone.

Caroline Phillips, Senior Vice President Biology, Redx Pharma commented: "These data, presented in hard-to-treat preclinical models, highlights the multiple opportunities for our lead asset RXC007. RXC007 is a highly selective, next-generation, ROCK2 inhibitor, currently in Phase 2a clinical studies for IPF, which has shown significant potential in other disease areas that we are excited to pursue in the future. Taken together with the data from our DDR1/2 programme currently in lead optimization, this provides support for new mechanisms to provide treatments for cancer-associated fibrosis which has been associated with poor prognosis in several cancers."

About Redx Pharma Plc

Redx Pharma (AIM: REDX) is a clinical-stage biotechnology company focused on the discovery and development of novel, small molecule, targeted therapeutics for the treatment of cancer and fibrotic disease and the emerging area of cancer-associated fibrosis, aiming initially to progress them to clinical proof of concept before evaluating options for further development and potential value creation. The Company's lead fibrosis product candidate, the selective ROCK2 inhibitor RXC007, is in development for interstitial lung disease being evaluated in a Phase 2a trial for idiopathic pulmonary fibrosis (IPF) with topline data expected in Q1 2024. Redx's lead oncology product candidate, the Porcupine inhibitor RXC004, being developed as a targeted treatment for Wnt-ligand dependent cancers, is expected to report Phase 2 data in combination with anti-PD-1 by end 2023. Redx's third drug candidate, RXC008, a GI-targeted ROCK inhibitor for the treatment of fibrostenotic Crohn's disease, is progressing towards a CTA application in H2 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 non-covalent (reversible) BTK inhibitor now approved by the US FDA for adult patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor, and AZD5055/RXC006, a Porcupine inhibitor targeting fibrotic diseases including IPF, which AstraZeneca is progressing in a Phase 1 clinical study. In addition, Redx has forged collaborations with Jazz Pharmaceuticals, which includes JZP815, a pan-RAF inhibitor developed by Redx which Jazz is now progressing through Phase 1 clinical studies, and an early stage oncology research collaboration. 

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