Multi-Stakeholder Alliance Created for Cancer Immunotherapy

Debiopharm International SA has recently announced they have entered a collaboration agreement with Merck and Pfizer to evaluate their drug in patients with non-small cell lung cancer.

The drug, Debio 1143, is a small molecule inhibitor of IAPs (inhibitor of apoptosis proteins), which is being developed for head and neck and ovarian cancers, according to a press release.

A new study will explore the use of Debio 1143 in combination with Merck-Pfizer’s drug avelumab, a fully human anti-PDL1 IgG1 monoclonal antibody in patients with advanced or metastatic non-small cell lung cancer.

Under the agreement, Debiopharm will be conducting the phase 1/1b clinical trial.

"We are delighted to initiate this collaboration in immuno-oncology with the Merck-Pfizer Alliance. It is a great opportunity to explore in the clinic the immunomodulatory properties of Debio 1143 observed in preclinical studies," said Chris Freitag, MD, 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."

Lung cancer is the leading cause of cancer mortality, and accounts for more deaths than colon, breast, and prostate cancer combined, Debiopharm reported. The 5-year survival rate of patients diagnosed with late stage disease is only 4%, indicating that more effective treatment options are needed.

Both drugs are investigative treatments that are being explored in a number of cancers, including non-small cell lung cancer (NSCLC). Debio 1143 promotes apoptosis by mimicking the natural second mitochondrial-derived activator of caspases. The drug also shows promise as a strong candidate as a combination treatment with an immune checkpoint inhibitor due to its immunomodulatory properties.

Avelumab is a fully human antibody specific for a protein found on PD-L1 tumor cells, and is thought to prevent tumor cells from using PD-L1 to protect against T cells, according to Debiopharm. The drug is also thought to help natural killer cells find and attack tumors through the antibody-dependent, cell-mediated cytotoxicity process.

"Inhibition of the PD-1/PD-L1 pathway has shown promising activity in patients with advanced NSCLC," said Alise Reicin, MD, head of Global Clinical Development in the biopharma business of Merck. "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."

Merck and Pfizer aligned for the development and commercialization of avelumab in 2014. All 3 companies hope that the combination of Debio 1143 and avelumab will provide an effective treatment for patients with the very common non-small cell lung cancer, according to a press release.

"Investigating the potential of combination therapy is an important strategic focus for the Merck-Pfizer Alliance," said Chris Boshoff, MD, PhD, 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."