LAUSANNE, Switzerland, October
20, 2016 /PRNewswire/ --
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
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.[1]
NSCLC is the most common type of lung cancer, accounting for 80-85%
of all lung cancers.[2] 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%.[3]
"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.
About Avelumab
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.
For more information, please see http://www.debiopharm.com
We are on Twitter. Follow @DebiopharmNews at
http://twitter.com/DebiopharmNews
References
- 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.
Debiopharm International SA Contact
Christelle Tur
Communication Coordinator
christelle.tur@debiopharm.com
Tel: +41-(0)21-321-01-11
SOURCE Debiopharm International SA