BioInvent entered 2024 with a solid financial reserve of 1358 SEK million, equivalent to 132 million USD. Anticipating significant milestones, the company is poised to release data from seven clinical studies throughout the year. Thus building on the momentum generated in 2023 with progress across six clinical programmes.
BioInvent uses a unique approach to discovering novel tumour targets suitable for cancer therapy and has developed several antibody candidates currently in clinical development, both as monotherapy and in combination with standard-of-care treatments. The lead products BI-1206 and BI-1808 are being tested in phase I/IIa trials for the treatment of Non-Hodgkin’s Lymphoma and solid tumours. Three other products, BT-001, BI-1607 and BI-1910 are being tried in early clinical studies, aimed as potential treatments for several cancer types.
In total, BioInvent has five drug candidates progressing through six clinical trials. In a recent interview with BioStock, Dr. Martin Welschof, CEO of BioInvent, emphasised that progress had been made in all programmes during 2023, providing validation to the proprietary F.I.R.S.T. antibody generation platform. Read more here: BioInvent’s CEO: “This year we made unprecedented progress”. (Dec 21, 2023)
Several data readouts expected during 2024
In a recent communication, BioInvent outlined its strategic priorities and anticipated milestones for 2024, forecasting a substantial influx of data throughout the year; Phase 1 combination data from lead programs BI-1808 and BI-1206 in H1/mid-2024 and data from five other clinical studies evaluating BI-1206 in NHL, single agent BI-1808, BI-1607, BT-001 and BI-1910.
Furthermore, BioInvent can sustain momentum in 2024 with the current development plan, supported by a robust financial reserve of 1358 million SEK.
Upcoming milestones with BI-1808
BI-1808 is an anti-TNFR2 antibody that targets regulatory T-cells in solid tumours and lymphoma. Developed with support from the Leukemia & Lymphoma Society’s Therapy Acceleration Programme, BI-1808 shows promise in cancer immunotherapy. A phase I study yielded positive interim results and demonstrated early signs of efficacy and a robust safety profile.
Administered as a single agent, BI-1808 induced a notable partial response in a patient with a gastrointestinal tumour, showing a 59 per cent reduction in tumour burden, and the patient is still on treatment. A further phase IIa trial explores its efficacy in expanded cohorts, including lung cancer, ovarian cancer, CTCL, melanoma, and other T-cell lymphomas.
BioInvent anticipates initial data from the BI-1808 and pembrolizumab combination study by Mid-2024. Initial data from the phase IIa BI-1808 single-agent trial are expected by year end.
Expectations with BI-1206
BioInvent also expects progress with its other leading candidate, BI-1206. This is an anti-FcyRIIB antibody aimed at enhancing existing cancer treatments like the multi-blockbuster drugs pembrolizumab and rituximab. Evaluated in separate clinical trials for non-Hodgkin’s lymphoma (NHL) and solid tumours, BI-1206 offers intravenous (IV) and subcutaneous (SC) formulations for treatment convenience.
In a phase I/IIa study with NHL patients, IV administration showed four complete responders (CR), three partial responders (PR), and four stable disease (SD) cases out of 15 patients. Long-lasting responses, with a median duration of 2,5 years, were observed. A phase IIa IV expansion study is ongoing. In solid tumours, phase I IV so far demonstrated efficacy with two long-lasting partial responses and stable disease in melanoma patients.
BioInvent anticipates data from the phase I SC dosing with rituximab in NHL during the first half of 2024. Further data from the phase I IV dosing with pembrolizumab for solid tumours is also expected during H1/mid-2024. By the end of 2024, the company anticipate having initial phase II data for BI-1206 in NHL.
Potential new deals after Exelixis
Two years ago, BioInvent signed an agreement with US based Exelixis. BioInvent received an upfront payment of 25 million USD in exchange for Exelixis’ rights to select targets identified using BioInvent’s F.I.R.S.T. platform and n-CoDeR library. In September 2023, a research milestone was reached, triggering a payment of 1 million USD to BioInvent. Exelixis recently terminated the agreement due to a restructuring program, where clinical and near-clinical programmes are prioritised over early research projects. The collaboration with BioInvent fell into the latter category.
Not only has the partnership generated great revenues for BioInvent. According to the company, it has also identified new and very interesting candidates. Meanwhile, they are now free to sign a new agreement with another licensee.
Multiple value-inflection points in 2024
Moving forward, In a statement addressing the prospective milestones set for 2024, BioInvent’s CEO Martin Welschof conveyed the company’s determination to capitalise on the positive momentum generated throughout the successful 2023. Welschof anticipates a similarly dynamic trajectory in 2024 with several upcoming milestones, all underpinned by the company’s robust financial standing:
“Going into 2024, we are eager to build on the momentum from a very successful 2023, where we made excellent progress with our six clinical programmes. We expect an equally busy 2024, with multiple value-inflection points including data sets for target engagement and initial phase II clinical proof-of-concept results from our growing portfolio of novel, first/best-in-class immune-modulatory antibodies.”
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