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BioInvent comments on breast cancer study progress

BioInvent comments on the progress in the breast cancer study

BioInvent comments on breast cancer study progress

13 December, 2023

BioInvent’s pipeline consists of five drug candidates advancing through six clinical trials. During the San Antonio Breast Cancer Symposium, BioInvent presented the first clinical data from one of these – the phase I/IIa trial of its second FcyRIIB-blocking antibody BI-1607. BioStock reached out to BioInvent’s Chief Medical Officer Andres McAllister for a comment.

With its n-CoDeR antibody library and F.I.R.S.T. screening platform for target and antibody discovery, BioInvent has yielded several promising candidates currently undergoing clinical evaluation. BI-1206 and BI-1808 are the leading candidates, followed by BT-001, BI-1607 and BI-1910.

Five drug candidates in six clinical trials

Last week, BioInvent announced the enrolment of the first patient in the phase I/IIa trial with the monoclonal antibody BI-1910. This marks the company’s second anti-tumour necrosis factor receptor 2 (TNFR2) programme to enter clinical development. In a press release, Martin Welschof, CEO of BioInvent, said:

“Enrollment of the first patient in our BI-1910 trial is an important milestone for BioInvent, marking our fifth drug candidate to enter clinical development.”

Milestone reached in the BI-1607 breast cancer study

That was not the only news coming from BioInvent last week. The Lund based pharmaceutical company also presented the first clinical data from a phase I/IIa trial with its second FcyRIIB-blocking antibody BI-1607.

Previous preclinical proof-of-concept data has indicated that combined treatment with BI-1607 may enhance efficacy of current anti-HER2 regimens and increase response rates in patients no longer responding to anti-HER2-directed therapies such as trastuzumab (Herceptin). BI-1607, like BI-1206, is intended to enhance the efficacy of and overcome resistance to existing cancer treatments.

The new phase I data that was presented in a poster at the San Antonio Breast Cancer Symposium last week, covered 18 patients treated at doses ranging from 75 mg up to 900 mg flat dose. The clinical trial is a first-in-human, open-label, multicenter, dose-escalation, consecutive-cohort study of BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumours.

The treatment was well tolerated, and no serious adverse events related to BI-1607 were observed. The best clinical response reported in the poster was stable disease (SD) in 4/11 evaluable patients, with disease control lasting up to 7 cycles (21 weeks). To date two additional SDs have been observed, adding to 6/11 evaluable patients.

A phase IIa trial with BI-1607 will start in 2024

In a press release, the company concluded that pharmacokinetic and pharmacodynamic data allowed the identification of a wide dose range, where complete target engagement throughout a 3-week dose interval can be achieved. This will provide the basis for further investigation in a phase IIa trial, which is planned to start next year.

Comments from BioInvent’s CMO

In a comment to BioStock, BioInvent’s Chief Medical Officer Andres McAllister said:

“We are very excited about the BI-1607 data, and what is coming next in development. In fact, BI-1607 can be thought of as a platform, very much like existing techniques to improve binding of MAbs to certain Fc receptors (such as defucosylation), except much better since it shuts down binding of the combining MAb to the inhibitory receptor. This should provide a strong enhancement of the activity of the combination partner. For example, we have generated a very strong preclinical data package demonstrating that BI-1607 can enhance the activity of anti-CTLA4 MAbs as well as the combination of anti-CTLA4/anti-PD1, allowing for a lower dose of anti-CTLA-4.”

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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