BioInvent International, a research-based pharmaceutical company based in Sweden, has reached an agreement with Cancer Research U.K., Cancer Research Technology (CRT), the charity’s development and commercialization arm, and Leukemia & Lymphoma Research (LLR) to take its investigational drug, BI-1206, into a collaborative phase I/II trial for patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL).
The first-in-man study will be funded and conducted by Cancer Research U.K., CRT and LLR. BioInvent has been granted the option to take up an exclusive license to the study data, subject to payment of milestones and royalties to CRT.
BI-1206 is a fully-human anti-CD32b antagonistic antibody that in addition to directly killing tumour cells is thought to work by maintaining CD20 antibodies on the cell membrane of cancer cells, preventing them from becoming resistant to the current state-of-the-art treatment, rituximab. The antibody has shown promise both in combination with CD20 antibodies and as a single agent in chronic lymphocytic lymphoma (CLL) and other types of NHL, in an extensive package of preclinical studies carried out by Leukemia & Lymphoma Research-funded scientists at the University of Southampton. The potential development opportunity for BI-1206 may extend well beyond NHL.
The open-label, phase I/ll study will enroll between 50 and 60 patients who will receive either BI-1206 alone or BI-1206 in combination with rituximab. The study will primarily enroll CLL patients but smaller cohorts of patients with other types of NHL, such as mantle cell lymphoma, follicular lymphoma and diffuse large B-cell lymphoma, also may be recruited. The study is expected to commence in the second half of 2015.
Each year in the U.K. approximately 12,800 people are diagnosed with NHL and 3,200 people are diagnosed with CLL. In Europe and North America around 157,000 people are diagnosed with NHL yearly and approximately 35,000 people are diagnosed with CLL.
Professor Chris Bunce, research director at Leukemia & Lymphoma Research, said, “Monoclonal antibodies have boosted survival rates for many types of lymphoma and leukemia in recent years, but patient responses remain varied. BI-1206 has shown great promise in reducing treatment resistance in the laboratory. Leukemia & Lymphoma Research has funded research into this treatment at the University of Southampton since 2008 and we’re very excited that through this partnership patients could benefit from it soon.”
Dr. Nigel Blackburn, Cancer Research U.K.’s director of drug development, said, “BI-1206 has performed well in preclinical studies, making it an ideal candidate for our clinical development partnerships program, which helps industry run trials of potential new cancer treatments that would otherwise never progress beyond the lab. There is a real need for new blood cancer drugs that help boost the effectiveness of conventional chemotherapy drugs, as many patients cannot tolerate or become resistant to these treatments over time. Consequently, we look forward to seeing the results of this trial.”
BI-1206 will be developed under Cancer Research U.K.'s Clinical Development Partnerships (CDP) program, a joint initiative between Cancer Research U.K.’s Center For Drug Development (CDD) and CRT, to develop promising anti-cancer agents, which pharmaceutical companies do not have the resources to progress through early phase clinical trials.
It is the first drug to be entered into a new partnership through which Cancer Research U.K. and Leukemia & Lymphoma Research will be jointly funding early phase clinical trials for patients with blood cancers.
Cancer Research U.K.’s CDD will manage and sponsor the study through the Experimental Cancer Medicine Center (ECMC) network, with Leukemia & Lymphoma Research providing the majority of the funding.