This joint effort will initially focus on a Phase I/Ib trial in patients with Lung Cancer to assess safety and preliminary efficacy of Debio 1143 in combination with avelumab
LAUSANNE, Switzerland, Oct. 20, 2016 /CNW/ - Debiopharm International (Debiopharm - http://www.debiopharm.com) today announced that it has entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer (NYSE: PFE) to evaluate Debio 1143, an oral, small molecule inhibitor of IAPs (Inhibitor of Apoptosis Proteins), in combination with avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). Debio 1143 is currently in Phase II development for Head & Neck and Ovarian Cancer. Avelumab is under clinical investigation across a broad range of tumor types by Merck KGaA, Darmstadt, Germany, and Pfizer. Under the terms of the agreement, Debiopharm will be responsible for conducting the Phase I/Ib clinical trial in NSCLC.
"We are delighted to initiate this collaboration in immuno-oncology with the strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer. It is a great opportunity to explore in the clinic the immunomodulatory properties of Debio 1143 observed in preclinical studies," said Dr Chris Freitag, Vice President, Clinical Research & Development, Debiopharm International SA. "We are hopeful that the immunosensitizing effect of our compound in combination with avelumab may translate into a potentially better treatment outcome for patients suffering from this major debilitating disease."
Globally, lung cancer is the leading cause of cancer death among both men and women, responsible for more deaths than colon, breast and prostate cancer combined. NSCLC is the most common type of lung cancer, accounting for 80-85% of all lung cancers. The 5-year survival rate for people diagnosed with late-stage lung cancer that has spread (metastasized) to other areas of the body is 4%.
"Inhibition of the PD-1/PD-L1 pathway has shown promising activity in patients with advanced NSCLC," said Alise Reicin, M.D., Head of Global Clinical Development in the biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. "We hope that our exploration of avelumab as a combination therapy with Debio 1143 will generate results that could potentially one day make a real difference to patients fighting this deadly cancer."
"Investigating the potential of combination therapy is an important strategic focus for the alliance between Merck KGaA, Darmstadt, Germany, and Pfizer," said Chris Boshoff, M.D., Ph.D., Head of Immuno-Oncology, Early Development, and Translational Oncology at Pfizer. "This collaboration with Debiopharm provides a significant opportunity to explore the potential synergistic effects of these two agents in combination."
About Debio 1143
Debio 1143 is an oral, small molecule inhibitor of IAPs (Inhibitor of Apoptosis Proteins) that promotes apoptosis of cancer cells by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC). Evasion of apoptosis is a hallmark of cancer and a common mechanism of resistance to current treatments and Debio 1143 is being investigated as chemo- and radio-sensitizer in Ovarian Cancer and Head & Neck Cancer. In addition, like other members of the class, Debio 1143 displays strong immunomodulatory properties that make it a natural candidate for combination with Immune Checkpoint Inhibitors.
Avelumab (also known as MSB0010718C) is an investigational, fully human antibody specific for a protein found on tumor cells called PD-L1, or programmed death ligand-1. Avelumab is thought to have a dual mechanism of action which may enable the immune system to find and attack cancer cells. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells such as T-cells, exposing them to anti-tumor responses. Avelumab is also thought to help white blood cells such as natural killer (NK) cells find and attack tumors in a process known as ADCC, or antibody-dependent cell-mediated cytotoxicity. In November 2014, the science and technology company Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.
About Debiopharm International SA
Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
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- American Cancer Society (2016) Key Statistics for Lung Cancer. Available from: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key-statistics. Accessed August 2016.
- American Cancer Society (2016) What is Non-Small Cell Lung Cancer? Available from: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer. Accessed August 2016.
- Mayo Clinic (2016) Cancer survival rate: what it means for your prognosis. Available from: http://www.mayoclinic.org/diseases-conditions/cancer/in-depth/cancer/art-20044517 . Accessed August 2016.
SOURCE Debiopharm International SA
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