Clinical Trials

Date: 2018-09-04

Type of information: Treatment of the first patient

phase: 1-2

Announcement: treatment of the first patient

Company: BioInvent (Sweden)

Product: BI-1206 and rituximab

Action mechanism:

• monoclonal antibody.
• Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells.
• 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.
• BioInvent believes that BI-1206 in combination with rituximab could be effective for hard-to-treat, aggressive forms of NHL or indolent lymphomas as they develop into more aggressive forms of the disease. In vitro and in vivo preclinical studies with BI-1206 already demonstrated its efficacy by preventing rituximab internalization into tumor cells, thereby leaving more rituximab available on the cell surface to exert an antitumoral effect. In addition, BI-1206 has a demonstrated direct single agent cytolytic activity in chronic lymphocytic leukaemia cells in vivo.
• BI-1206 is currently being assessed in the dose escalation Phase I/II clinical trial in patients with relapsed or refractory CD32b-positive B cell malignancies conducted by Cancer Research UK in the UK, with a first read-out expected in H1 2018.

Disease: relapsed or refractory non-Hodgkin lymphoma (NHL) including mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma

Therapeutic area: Cancer - Oncology

Country: Sweden, USA

Trial details:

• This is a Phase 1/2a, dose escalation, consecutive-cohort, open-label study trial of BI-1206 in combination with rituximab in subjects with indolent relapsed or refractory B-cell NHL. The study trial will consist of 2 main parts: Phase 1 (with dose escalation cohorts using a 3+3 dose-escalation design and selection of the RP2D), and Phase 2a (the escalation expansion cohort at the RP2D). Subjects in each phase will receive 1 cycle (4 doses) of induction therapy with BI-1206 in combination with rituximab. Subjects who show clinical benefit (complete response [CR], partial response [PR], or stable disease [SD]) at Week 6 will continue onto maintenance therapy and receive BI-1206 and rituximab once every 8 weeks (relative to previous maintenance dose) for up to 6 maintenance cycles, or up to 1 year from first dose of BI-1206 (whichever occurs first). (NCT03571568)

Latest news:

• • On September 4, 2018, BioInvent started dosing of the first patient in a dose escalation, consecutive-cohort, open-label phase I/IIa study of BI-1206 after recently obtaining approval from the Swedish Medical Product Agency and the FDA to initiate patient inclusion. The study will recruit approximately 30 patients across sites in the EU and the U.S. The study will explore BI-1206’s safety and tolerability, and seek to determine a recommended phase ll dose when given in combination with rituximab.
• • On July 12, 2018, BioInvent International announced that the FDA has accepted its Investigational New Drug (IND) Application for its new clinical study that will explore the activity of BI-1206 in combination with rituximab. The Swedish Medical Product Agency recently approved the initiation of the same study in Sweden.
• • On May 9, 2018, BioInvent announced that it has received authorization to proceed from the Swedish Medical Product Agency for a new clinical trial that will study the activity of BI-1206. The new clinical study is a Phase l/lla, dose escalation, consecutive-cohort, open-label study of BI-1206 in combination with rituximab in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). The targeted sub-indications are mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma. The clinical evaluation of BI-1206 is ongoing in a parallel Phase I/IIa study in the UK, which is performed by Cancer Research UK (NCT02933320).
• • On October 23, 2017, BioInvent announced its plans to expand the therapeutic potential of its lead antibody BI-1206. The current development program will be expanded with an open, single-arm Phase I/IIa clinical study to evaluate BI-1206 in combination with rituximab. This study is estimated to enrol approximately twenty patients with relapsed or refractory non-Hodgkin lymphoma (NHL), and will include patients with mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma. The trial is planned to start in H1 2018, and the last patient is expected to finish the trial before the end of 2019.
• The new study will assess the safety and tolerability of BI-1206 in combination with rituximab, as well as early signs of efficacy. During the clinical trials, biomarkers that may predict patients’ responses to treatment will also be monitored.

 

Is general: Yes