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17.09.2020 – 09:00

Debiopharm International SA


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Lausanne, Switzerland (ots)

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 Debio 0123

Debiopharm, ( a biopharmaceutical company based in Switzerland, today announced data releases on 2 investigational oncology programs including xevinapant (Debio 1143) and their selective WEE1 inhibitor (Debio 0123), at the European Society Of Medical Oncology (ESMO) Virtual Congress 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.

The virtual late breaking abstract presentation of the 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, 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 ( investigational therapy + chemoradiotherapy (CRT) vs. CRT alone.

In addition, two phase I posters will be made available for xevinapant in combination with nivolumab and for Debio 0123, the oral WEE1 inhibitor in combination with carboplatin for the treatment of solid tumors.

"We are excited to introduce first clinical data with Debio 0123 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," expressed 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, " commented Pr. Jean Bourhis, Head of the Radio-Oncology Department CHUV, Lausanne, Switzerland, and Lead Investigator of the study. "These results suggest a chemo-radio-enhancing effect, warranting further assessment during an ongoing phase III trial for LA-SCCHN patients."

ESMO 2020         Abstract                           Presenting investigator
Session Details		

Sept.19th         LBA39 - 3-years follow-up of       Prof. Jean Bourhis, 
Channel 3         double-blind randomized phase II   Head of Radio-Oncology
12:54 - 13:04     comparing concurrent               CHUV, Lausanne, 
                  high-dose cisplatin                Switzerland, Lead study 
Proffered Paper-  chemo-radiation plus               author 
Head and neck     Debio-1143 (xevinapant)          
cancer session    or placebo in high-risk patients 
12:30 - 14:10     with locally advanced 
                  squamous cell carcinoma 
                  of the head and neck

Sept. 17th        560P - Safety and efficacy         Analia B. Azaro Pedrazzoli
                  of Debio 1143, an                  (Barcelona, Spain)
Poster Display    antagonist of inhibitor  
Session           of apoptosis proteins (IAPs),
                  in a phase Ib/II trial in patients 
                  (pts) failing prior PD-1/PD-L1 
                  treatment in combination with 

Sept. 17th        601TiP - First-in-human phase      Hans Gelderblom 
                  I study of a novel oral            (Leiden, Netherlands)
Poster Display    Wee1 inhibitor (Debio 0123)
Session           in combination with 
                  carboplatin in patients
                  with advanced solid tumors

Virtual           Visit the Debiopharm               Questions & Live Chat 
Exhibition        virtual booth here                 Available

About xevinapant

Xevinapant (Debio 1143) 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.

About Debio 0123

Debio 0123 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.

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.

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Debiopharm Contact
Dawn Haughton
Communication Manager
Tel: +41 (0)21 321 01 11

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