On June 5, 2023 Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of new oncology treatments, reported its intention to expedite further global clinical development of the next generation selective RET inhibitor (SRI) EP0031/A400 following the publication of ‘very encouraging’ clinical data (Press release, Ellipses Pharma, JUN 5, 2023, View Source [SID1234632495]).

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Professor Tobias Arkenau, Global Head of Drug Development & CMO at Ellipses, commented:

"The data presented today gives everyone involved great confidence to further progress our clinical trial programme. The results have been marked in terms of significant tumour shrinkage across RET-altered tumours and importantly EP0031 had an encouraging safety and tolerability profile. This is an exciting development, and we look forward to rapidly advancing with our next phase of clinical work."

EP0031 is being developed in partnership with Kelun-Biotech Pharmaceutical Co. Ltd. (Kelun-Biotech) and is also known as A400 when in conjunction with Kelun-Biotech’s ongoing regional development.

Trial data of the Phase 1 Study of KL590586 (EP0031/A400), presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference in Chicago today, reported preliminary efficacy and safety for a total of 109 patients. A400/EP0031 was generally well tolerated with the majority of adverse events recorded as manageable grade 1 or 2. In the overall RET-altered tumour population, patients who received A400/EP0031 at doses between 40 and 120mg OD had an objective response rate of 60% with a disease control rate of 90%. Two specific treatment cohorts were highlighted at the meeting: i) patients, with previously untreated RET-fusion positive advanced NSCLC with an objective response rate of 80.8% (21/26 patients); and ii) patients with RET-fusion positive NSCLC who had received prior systemic treatment (median prior line 2, range 1-9), including chemo-immunotherapy, with an objective response rate of 69.7% (23/33 patients). Disease control rates of >96% were reported for each cohort. Importantly, evidence of clinical activity was also reported in cohorts of patients with brain metastases as well as patients that had received prior 1st generation SRI.

EP0031/A400 is the subject of a global, modular Phase 1/2 trial to evaluate safety, tolerability and efficacy in patients with advanced RET-altered tumours and has been under clinical investigation in China by Kelun-Biotech for patients with RET-altered cancers. Clinical dose expansion data from the latter study were reported at the ASCO (Free ASCO Whitepaper) conference today.

Professor Sir Christopher Evans, OBE, Chairman, Ellipses, commented:

"From the outset of Ellipses, we have remained firmly focused on the selection of only the most promising oncology discoveries through our global network of over 200 key opinion leaders and our unbiased vetting approach. We are delighted to see EP0031 progressing so well through its clinical trial journey. It offers great potential to address a significant unmet need in oncology and extend the treatment options for patients."

Dr Rajan Jethwa, Chief Executive Officer, Ellipses, commented:

"EP0031/A400 is a promising next generation SRI. We welcome the very striking clinical data presented by our partners at Kelun-Biotech, which marks an important step in the development of this agent. EP0031 offers the potential to further improve patient outcomes and the rapid pace at which its clinical programme is progressing provides further evidence that our approach accelerates drug development for the benefit of patients. Data presented today will be augmented by results from our Phase1/2 trial currently underway in the US, EU and UK."

Dr Junyou Ge, Chief Executive Officer of Kelun-Biotech, commented:

"EP0031/A400 offers a significant therapeutic potential for tumours with RET oncogene mutation/fusion and is hoped to bring new treatment options for patients. The clinical data presented today is extremely encouraging and Kelun-Biotech will continue to collaborate with Ellipses to promote the global development and subsequent potential commercialisation of this treatment to benefit more cancer patients around the world."