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Clinical progress for key assets Redx is gaining a reputation as a respected creator of innovative small molecule drugs based on its proven expertise in medicinal chemistry, which underpins its discovery platform. Four major partnership deals have been struck, with the focus now to advance key in-house assets (RXC004, a porcupine inhibitor for oncology, and RXC007, a ROCK2 inhibitor for fibrosis) to major inflection points. Both assets are progressing well: RXC004 is due to deliver Phase I data and enter Phase II trials, and RXC007 to enter Phase I, during 2021.
Funding through to end-2022 The past 12 months have seen Redx's balance sheet transformed as new funds, both as equity and convertible loan notes, were raised. Existing cash resources, and risk-adjusted forecast milestone income, will be invested in progressing RXC004 and RXC007 and in broadening the earlier R&D pipeline, notably in further oncology and fibrosis research. The cash runway now extends to end-2022, suggesting several value-inflection points can be achieved.
Proven management and a clear strategy Whilst Redx's medicinal chemistry expertise drives the business model, it is its management that is successfully executing the strategy. The aim is to develop first-in-class molecules addressing novel targets and best-in-class drugs directed at scientifically validated pathways. These are then progressed to Phase II proof of concept and, if successful, will then be outlicensed. The ability to strike attractive deals has now been demonstrated.
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Redx's strategy aims to leverage its now well-established expertise in medicinal chemistry to develop both first-in-class molecules addressing novel targets and best-in-class drugs directed at known and scientifically validated pathways. The focus is on genetically-defined oncology indications and fibrotic diseases, with the goal to achieve three IND (Investigational New Drug) applications by 2025. Selected candidates are progressed to Phase II proof of concept clinical trials before being out-licensed, with an element of commercial revenues retained; however, assets will be out-licensed earlier if the proposed returns are sufficiently attractive. Even a relatively modest delivery on this well-articulated and ambitious strategy should be transformative for the business over the medium term.
As we stated in our
RXC004 completing Phase I clinical trial
RXC004 is a highly selective and potent small molecule that targets the porcupine (Porcn) enzyme on the Wnt (Wingless type) signalling pathways. Wnt ligands play a critical role in balancing cell proliferation, differentiation, and cellular homeostasis. Dysregulation is known to drive many cancer types, particularly those that have a poor prognosis, with elevated activity resulting in drug resistance. The pathway is complex and difficult to address, with the porcupine enzyme seen as an attractive target. Comprehensive preclinical studies have shown RXC004 to have promising direct anti-tumour activity in cancer lines with upstream mutations in this pathway, for instance RNF43. Additionally, RXC004 enhances the immune response in the tumour microenvironment and hence has a possible dual mechanism of action (Exhibit 3).
RXC004 is currently in a dose escalation Phase I trial to examine its safety and tolerability. The study is set to enrol around 20 patients across five centres in the
The Phase II programme will similarly explore both monotherapy and a CPI combination. Monotherapy studies will likely explore RXC004 in geneticallyselected MSS mCRC (micro-satellite stable metastatic colorectal cancer), selected pancreatic cancer, and all biliary cancers, with the combination therapy evaluating genetically-selected MSS mCRC (at least initially). There are currently four other porcupine inhibitors known to be in clinical development, with Novartis' WNT974 (LGK974) being arguably the most advanced. The data from the Phase I study is awaited keenly, particularly for early signals of direct efficacy. It may also provide an insight into whether RXC004 could be the better compound in terms of expected efficacy and, possibly, side-effect profile than WNT974
The move into Phase II trials is planned for 2021 but, along with most similar clinical studies, timings may be impacted by COVID-19 factors. The Phase II data would be the prelude to out-licensing discussions.
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