Debiopharm Advances its Potent Wee1 Inhibitor into Clinical Phase

Initially developed by Almac Discovery, Debio 0123 commences First-In-Human, dose escalation phase I clinical trial for the treatment of refractory solid tumours

Belfast, Northern Ireland- March 5, 2020 – Debiopharm – a Swiss biopharmaceutical company, has announced the advancement of its first-in-human, phase 1 study as patients with advanced solid tumours will be administered with cancer treatment Debio 0123 in combination with carboplatin. The molecule was initially discovered by innovative biotech company, Almac Discovery, before being in-licensed by Debiopharm in 2017.

The oral, potent and highly selective WEE-1 inhibitor has shown anti-tumour activity both as a single agent and in combination with carboplatin in pre-clinical cancer models. The advancement of Debio 0123 into clinical studies may reveal improved therapeutic results for cancer patients.

This dose escalation trial will be conducted in patients with refractory solid tumours that have recurred or progressed following prior platinum-based chemotherapy and for which no standard treatment is available. Currently one of three WEE1 inhibitors in clinical development, the Debio 0123 program was initiated based on the deepened understanding of the DNA damage response (DDR) of cancer cells.

Dr Stephen Barr, Managing Director & President, Almac Discovery commented “We are delighted with the positive results exhibited thus far as Debiopharm continues to develop this drug candidate. We watch, with much interest, as the Wee1 inhibitor continues through clinical trials with the hope of becoming an effective treatment for cancer patients across the globe.”

The DNA in cancer cells can be damaged by a variety of treatments such as radiation, antimetabolites, alkylating agents, DNA topoisomerase inhibitors and platinum-based chemotherapy. When this damage occurs, the cells respond by pausing the cell cycle temporarily to allow for DNA repair, hence reducing the effectiveness of cytotoxic therapies against the cancer cells.

Treatments such as Debio 0123, which inhibit the DDR, are promising drug candidates as they can enhance the effects of DNA damaging therapies and promote a lethal response. The WEE-1 kinase is a key regulator of several cell cycle checkpoints including G2/M. WEE-1 inhibition can force cells in a state of arrest to continue the cell cycle, ultimately leading to cell death. The resulting impairment of the G2-M checkpoint would prevent cancer cells from repairing induced DNA damage, considerably enhancing the effect of the DNA damaging therapy and thus optimizing the therapeutic outcome.

“This clinical phase of Debio 0123 is highly anticipated in light of the therapeutic potential of the molecule. Research results suggests that this potent WEE-1 inhibitor could positively impact outcomes for cancer patients, particularly in combination with DNA damaging treatments, such as chemo- and radiation-therapies” explained Angela Zubel, Chief Development Officer, Research & Development, Debiopharm.

ENDS

About Almac Discovery

Almac Discovery is an innovative research driven biotech company dedicated to the discovery and development of novel approaches to the treatment of illnesses across a wide range of therapeutic areas including neuroscience, muscle-wasting, oncology and inflammation. Almac Discovery focuses on the discovery to preclinical stage seeking to licence programmes early with a pharmaceutical partner for further development.

For more information, please visit almacgroup.com/discovery or e-mail [email protected].

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

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