Boehringer Ingelheim Advances Novel Bi-specific TRAILR2/CDH17 Antibody to Phase 1 Clinical Trial for Patients Living with Gastrointestinal Cancers

Ingelheim, Germany – 10 September 2020 – Boehringer Ingelheim today announced 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. 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.

“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.

Learn more about Boehringer Ingelheim’s innovation in oncology here.

About Boehringer Ingelheim
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

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