Debiopharm Further Explores the Potential of Potent, Highly Selective WEE1 Inhibitor in Phase 1 Cancer Study

December 16, 2021

Dose escalation, monotherapy trial launched to assess the safety and preliminary anti-tumor activity of Debio 0123, initially discovered by Almac Discovery, in the treatment of advanced solid tumors

Craigavon, N.I., Thursday 15 December 2021Almac Discovery , the research driven drug discovery company, is delighted that Debiopharm, a Swiss biopharmaceutical company, has launched a dose escalation trial to assess the safety and preliminary anti-tumour activity of Debio 0123 as a monotherapy in patients with advanced solid tumors (NCT05109975). Debio 0123 is an oral, potent and highly selective WEE1 inhibitor initially discovered by Almac Discovery and in-licensed by Debiopharm in 2017.

Part of an emerging new class of drugs working within the DNA damage response (DDR) pathway, the compound’s anti-tumour capacity has been evaluated in several preclinical studies along with the ongoing phase I study in combination with carboplatin-based chemotherapy. This new trial’s primary objective is to identify the maximum tolerated dose and/or recommended phase II dose in a¬¬dults with advanced solid tumors that have recurred or progressed after prior therapy and/or for whom no standard therapy of proven benefit is available.

The evaluation of Debio 0123 as monotherapy could help to better characterize the safety and efficacy profile of the compound in a clinical setting and define the parameters for eventual phase II research. Pre-clinical research highlights its potential for efficacy in cancer patients, particularly in combination with DNA damaging agents such as chemo- and radiotherapy. Debiopharm plans to advance the clinical program while simultaneously negotiating potential partnerships, such as during the upcoming JP Morgan 2022 conference, with larger pharmaceutical companies for eventual commercialization.

Dr Stephen Barr, Managing Director & President, Almac Discovery commented, “Since the discovery of our highly selective WEE1 inhibitor, now known as Debio 0123, we have looked forward with anticipation to understanding its potential therapeutic benefit for cancer patients across the globe. We are therefore delighted that, in addition to the ongoing combination clinical study, Debio 0123 is also being evaluated as a monotherapy in the treatment of advanced solid tumors. We look forward to seeing further progress from this ongoing clinical research.”

“We’re intrigued to learn more about the clinical benefits that WEE1 inhibition with Debio 0123 alone could offer cancer patients. We believe that this new modality can effectively exploit the genomic instability and malfunctioning of the DNA repair process in cancer cells in hopes that ultimately tumor progression is halted and patient survival is improved,” added Dr. Esteban Rodrigo Imedio, Senior Medical Director, Oncology Research & Development, Debiopharm. “As Debio 0123 is highly selective against WEE1, in time, ongoing clinical research could confirm Debio 0123’s potential best-in-class status.”



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