drugset / Press release

Debiopharm to Present Late Breaking Head & Neck Cancer Abstract at the 2020 European Society Of Medical Oncology Congress

2020-09-17 · Debiopharm International SA · original debiopharm.com ↗

Debiopharm announces the presentation of the 3-year phase II follow-up data along with 2 posters for xevinapant (antagonist of IAP -Inhibitor of Apoptosis Proteins) and WEE1 inhibitor Debio0123 – Debiopharm, ( ) a biopharmaceutical company based in Switzerland, today announced data releases on 2 investigational oncology programs including and their selective , at the taking place virtually from September 19th – 21st. The abstract and poster presentations are a part of Debiopharm’s maturing oncology portfolio which evaluates novel, first-in-class oncology and compounds that respond to high unmet needs in a wide range of cancer types. Lausanne, Switzerland –September 17th 2020 www.debiopharm.com xevinapant (Debio1143) WEE1 inhibitor (Debio0123) European Society Of Medical Oncology (ESMO) Virtual Congress The virtual late breaking abstract presentation of the , will be given by professor Jean Bourhis, lead investigator of the study. The talk will include the statistically significant overall survival data suggesting the reduction of the risk of death by 50% with this phase III (https://patients.debiopharm.com/head-and-neck-cancer/) investigational therapy + chemoradiotherapy (CRT) vs. CRT alone ( ). 3-year update for the xevinapant phase II study in high-risk previously untreated locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) patients link to study In addition, two phase I posters will be made available for in combination with nivolumab and for in combination with carboplatin for the treatment of solid tumors. xevinapant Debio0123, the oral WEE1 inhibitor “We are excited to introduce first clinical data with Debio0123 and provide a number of important updates on xevinapant during the upcoming ESMO meeting. The updated clinical data from our phase II study in Head & Neck cancer will highlight our progress towards developing a novel therapy that could significantly extend the lives of these high risk patients.” – Angela Zubel – Chief Development Officer, R&D, Debiopharm “The benefit to patients with xevinapant vs. chemo-radiotherapy alone at 3 years is an improvement that has not been seen in over 30 years of research. These results suggest a chemo-radio-enhancing effect, warranting further assessment during an ongoing phase III trial for LA-SCCHN patients .” – Pr. Jean Bourhis, Head of the Radio-Oncology Department CHUV, Lausanne, Switzerland, and Lead Investigator of the study ESMO 2020 Abstract: LBA39 – 3-years follow-up of double-blind randomized phase II comparing concurrent high-dose cisplatin chemo-radiation plus Debio-1143 (xevinapant) or placebo in high-risk patients with locally advanced squamous cell carcinoma of the head and neck Prof. Jean Bourhis, Head of Radio-Oncology CHUV, Lausanne, Switzerland, Lead study author Presenting investigator: Proffered Paper – Head and neck cancer session 12:30 – 14:10) Sept.19th, Session details: Channel 3 from 12:54 – 13:04 ( Abstract 560P – Safety and efficacy of Debio1143, an antagonist of inhibitor of apoptosis proteins (IAPs), in combination with nivolumab in a phase Ib/II trial in patients (pts) failing prior PD-1/PD-L1 treatment Analia B. Azaro Pedrazzoli (Barcelona, Spain) Presenting investigator: Available Sept. 17th (Poster Display Session) Session details: Abstract 601TiP – First-in-human phase I study of a novel oral Wee1 inhibitor (Debio0123) in combination with carboplatin in patients with advanced solid tumors Hans Gelderblom (Leiden, Netherlands) Presenting investigator: Available Sept. 17th (Poster Display Session) Session details: Debiopharm Virtual Booth Visit our booth . Questions & Live chat available here About xevinapant is a potential first-in-class oral antagonist of IAPs (inhibitor of apoptosis proteins), that sensitizes tumor cells to radio-chemo-therapy by promoting programmed cell death and fostering anti-tumor immunity. The clinical benefit observed in high risk LA-SCCHN patients suggests that the addition of xevinapant into widely used CRT regimens is a promising investigational approach over a broad range of cancer types. Over 200 patients have been treated so far in various indications and lines of treatment, showing an adequate and consistent safety profile across studies. Xevinapant (Debio1143) About Debio0123 is a Wee1 kinase inhibitor. Wee1 is a key regulator of the G2/M and S phase checkpoints, activated in response to DNA damage, to allow cells to repair their DNA before resuming their cycle. Inhibition of WEE1, particularly in combination with DNA damaging agents, induces an overload of DNA breaks, and in conjunction with abrogation of other checkpoints, such as G1 controlled by p53, pushes the cells through cycle without DNA repair, promotes mitotic catastrophe and induces apoptosis of cancer cells. Debio0123 Debiopharm’s commitment to cancer patients Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit www.debiopharm.com We are on Twitter. Follow us at @DebiopharmNews http://twitter.com/DebiopharmNews

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