BioInvent uses a unique approach to discover novel tumor target structures suitable for cancer treatment. The company has developed several antibody candidates that are currently in clinical development, both as monotherapy and in combination with current standard treatments. The drug candidates BI-1206 and BI-1808 is being tested in Phase I/IIa studies for the treatment of Non-Hodgkin's lymphoma and solid tumors. Three other products, BT 001, BI-1607 and BI-1910, are being tested in early clinical trials, as potential treatments for several types of cancer.
In total, BioInvent has five drug candidates that are going through six clinical trials. In a recent interview with BioStock, BioInvent's CEO, Dr. Martin Welschof, that progress has been made in all programs in 2023, validating the proprietary technology platform for generating antibodies – FIRST Read more here: BioInvent's CEO: "This year we made unprecedented progress" (December 21, 2023)
More data readings expected in 2024
BioInvent recently communicated its strategic priorities and expected milestones for 2024. The company anticipates a significant influx of data during the year; Phase 1 combination data from the lead programs BI-1808 and BI-1206 in H1/mid 2024 as well as data from five other clinical studies evaluating BI-1206 in NHL, BI-1808, BI-1607, BT-001 and BI-1910. In addition, BioInvent can maintain momentum in 2024 according to the current development plan, supported by a robust financial reserve of SEK 1358 million.
Upcoming milestones with BI-1808
BI-1808 is an anti-TNFR2 antibody that targets regulatory T cells in solid tumors and lymphomas. BI-1808, which is being developed with support from Leukemia & Lymphoma Society's Therapy Acceleration Programme, has shown promise as a cancer immunotherapy. A Phase I study generated positive interim results, showing early signs of efficacy and a robust safety profile.
When administered as monotherapy, BI-1808 induced a remarkable partial response in one of the patients with a gastrointestinal tumor. The tumor burden was reduced by 59 percent and the patient is still on treatment. A phase IIa study is investigating its efficacy in expanded cohorts, including lung cancer, ovarian cancer, CTCL, melanoma and other T-cell lymphomas.
BioInvent expects initial data from the combination study of BI-1808 and pembrolizumab in mid-2024. Initial data from the phase IIa study of BI-1808 as monotherapy is expected by the end of the year.
Expectations regarding BI-1206
BioInvent also expects progress with its second lead candidate, BI-1206. This is an anti-FcγRIIB antibody that aims to improve existing cancer treatments such as the blockbuster drugs pembrolizumab and rituximabBI-1206 is being evaluated in separate clinical trials for non-Hodgkin's lymphoma (NHL) and solid tumors and offers intravenous (IV) and subcutaneous (SC) formulations to facilitate treatment.
In a phase I/IIa study in NHL patients, intravenous administration showed four cases of complete response (CR), three cases of partial response (PR) and four cases of stable disease (SD) in 15 patients. Long-lasting responses to treatment, with a median duration of 2,5 years, were observed. A phase IIa expansion study with intravenous BI-1206 is ongoing. In solid tumors, the intravenous part of the phase I study has so far shown efficacy with two long-lasting partial responses and stable disease in melanoma patients.
BioInvent expects to present data from the Phase I subcutaneous dose in combination with rituximab in NHL in the first half of 2024. Additional data from the Phase I IV dose with pembrolizumab in solid tumors is also expected in H1/mid-year. The company expects to have initial Phase II data for BI-1206 in NHL by the end of 2024.
Potential new deals after Exelixis
Two years ago, BioInvent signed an agreement with the US-based Exelixis. BioInvent received an upfront payment of USD 25 million in exchange for Exelixis’ rights to select targets identified with BioInvent’s FIRST platform and n-CoDeR library. In September 2023, a research milestone was reached, triggering a payment of USD 1 million to BioInvent. Exelixis recently terminated the agreement due to a restructuring program, where clinical and near-clinical programs are prioritized over early-stage research projects. The collaboration with BioInvent fell into the latter category.
The agreement has not only generated good revenues for BioInvent, but according to the company, it has also identified new and very interesting candidates. At the same time, they now have the opportunity to sign a new agreement with another licensee.
Several significant milestones in 2024
In a statement regarding the potential milestones for 2024, BioInvent CEO Martin Welschof conveyed that the company will build on the positive momentum generated during a successful 2023. Welschof expects a similar good development in 2024 with several upcoming milestones, supported by the company's robust financial situation:
"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 programs. 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."