On September 10, 2020 Boehringer Ingelheim reported the advancement of the bi-specific and tetravalent therapeutic antibody, BI 905711, to its first-in-human clinical trial for patients with advanced gastrointestinal (GI) cancers (Press release, Boehringer Ingelheim, SEP 10, 2020, View Source [SID1234564934]). The first-in-class BI 905711 antibody is designed to recognize both the pro-apoptotic tumor necrosis factor (TNF)-related apoptosis-inducing ligand receptor 2 (TRAILR2) and the tumor cell anchor cadherin 17 (CDH17) to activate the self-destruction (apoptosis) pathway in co-expressing tumor cells found mostly in the GI tract. For patients suffering from these types of cancers, the advancement of the Phase 1 trial marks an important milestone in the continuing development of more tolerable innovative therapies to address diseases with high unmet need.
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"We are proud to advance BI 905711 into Phase 1 clinical trials as we continue to grow our oncology pipeline to transform patients’ lives. This bispecific platform has the potential to target complex mechanisms that may not be accessible with traditional antibody formats," said Norbert Kraut, Ph.D., Head of Global Cancer Research at Boehringer Ingelheim.
Gastrointestinal cancers are a leading cause of cancer-related deaths throughout the world. Of gastrointestinal cancers, colorectal cancer, a focus of this Phase 1 trial, is the third most common cancer with more than 1.8 million cases and the second most deadly cancer with more than 880,000 deaths globally in 2018 (Globocan 2018).¬ To date there have been few innovative treatment options available for patients diagnosed with GI malignancies, making chemotherapy, despite its known severe side effects, the backbone of treatment. A proven targeted therapeutic option that does not require chemotherapy efficacy support could provide patients with an alternative, innovative and potentially non-toxic treatment option.
James Harding, M.D., Principal Investigator, Department of Early Drug Development and Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center, New York, USA, said, "Targeting TRAILR2/CDH17 co-expressing cancer cells has exhibited preclinical antitumor activity. We look forward to evaluating this molecule with Boehringer Ingelheim in the ongoing Phase 1 study."
Patients with tumors of the gastrointestinal tract are underserved by recent innovations in cancer therapy and are in critical need of new treatment options. Boehringer Ingelheim is committed to addressing the unmet need in these patients’ lives and continues to develop innovative drug candidates, such as BI 905711, providing potentially powerful and previously untested approaches to cancer treatment.
Boehringer Ingelheim Oncology is taking cancer on by leading the science with cancer cell directed agents, immuno-oncology therapies, and their combinations to address unmet needs in lung and gastrointestinal cancers. The company invests significantly in early stage research to identify unexplored and undrugged pathways of cancer. In 2019, Boehringer Ingelheim advanced six molecules to first-in-human studies, including two further first-in-class compounds targeting the Wnt/β-catenin pathway (BI 905681) and KRAS-driven cancers (BI 1701963), demonstrating the company’s long term commitment to leading science, improving clinical practice, and ultimately transforming the lives of patients – helping them to win the fight against cancer.