Date: 2015-01-20
Type of
information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: BioInvent International (Sweden) Cancer Research UK (UK) Cancer Research Technology (CRT) (UK) Leukaemia & Lymphoma Research (UK)
Product: BI-1206
Action
mechanism:
- monoclonal antibody. 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 Leukaemia & Lymphoma Research-funded scientists at the University of Southampton.
Disease: chronic lymphocytic leukaemia (CLL), non-Hodgkin lymphoma (NHL)
Therapeutic
area: Cancer - Oncology
Country: UK
Trial
details:
- The purpose of this study is to identify the tolerable dose of BI-1206 for patients with B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an anti-CD20 antibody. (NCT02933320)
Latest
news:
- • On January 20, 2015, BioInvent International has reached an agreement with Cancer Research UK, Cancer Research Technology (CRT), the charity's development and commercialisation arm, and Leukaemia & Lymphoma Research (LLR) to take its investigational drug, BI-1206, into a collaborative phase I/II trial for patients with chronic lymphocytic leukaemia (CLL) and non-Hodgkin lymphoma (NHL). The first in man study will be funded and conducted by Cancer Research UK, 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 Cancer Research Technology.
- 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, may also be recruited. The study is expected to commence in the second half of 2015. BI-1206 will be developed under Cancer Research UK's Clinical Development Partnerships (CDP) program, a joint initiative between Cancer Research UK's Centre 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 UK and Leukaemia & Lymphoma Research will be jointly funding early phase clinical trials for patients with blood cancers.
- Cancer Research UK's CDD will manage and sponsor the study through the Experimental Cancer Medicine Centre (ECMC) network, with Leukaemia & Lymphoma Research providing the majority of the funding.
Is
general: Yes
