Micrograph of a solid pseudopapillary tumour of the pancreas. Credit: Nephron.

Boehringer Ingelheim has expanded its strategic partnership with Sarah Cannon Research Institute to investigate BI 891065 in a Phase I clinical trial to treat patients with solid tumours.

BI 891065 is a potent small molecule SMAC mimetic being developed to stimulate cell death of tumours and activate immune system to potentially enhance the immunotherapy activity.

The Phase I trial will evaluate BI 891065 as monotherapy and combination therapy with an anti-PD-1 cancer treatment, BI 754091, for advanced metastatic tumours and will enrol around 100 subjects

The interventional, non-randomised, open-label trial will assess the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of BI 891065.

Boehringer Ingelheim Oncology global medical head Mehdi Shahidi said: “We are significantly expanding our efforts in this area, including a broad research programme focusing on the development of rational combinations of novel immuno-oncology approaches.

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“The Phase I trial will evaluate BI 891065 as monotherapy and combination therapy with an anti-PD-1 cancer treatment, BI 754091, for advanced metastatic tumours.”

“As part of these ongoing efforts to transform the lives of cancer patients, we are extremely proud to be one of the first companies to bring this innovative combination therapy of an immune checkpoint inhibitor and a small molecule targeted treatment to the clinical stage of development.”

The trial aims to establish a maximum tolerated dose (MTD) and/or recommended dose, while the secondary objectives are pharmacokinetic (PK) profile of BI 891065 alone and when combined with BI 754091, and preliminary assessment of anti-tumour activity.

Under a joint clinical development programme, the firms previously investigated Boehringer’s BI 754091 and BI 754111 monoclonal antibodies for the treatment of various cancers.

The current extension of the partnership is intended to accelerate patient enrolment and expand access to Boehringer’s investigational oncology treatments through Sarah Cannon’s network in the US and UK.