BioInvent Reports Positive Phase 1 Results for BI-1910 in Solid Tumors

BioInvent International AB, a biotech firm from Sweden, has revealed clinical findings for its second anti-TNFR2 antibody, BI-1910. This marks a significant step in the development of new checkpoint inhibitors for cancer treatment. The company is also advancing BI-1910 in combination with MSD's immunotherapy drug, KEYTRUDA® (pembrolizumab).

Phase 1 trials for BI-1910 as a standalone treatment have shown promising results, with the completion of the dose escalation phase. Impressively, no serious side effects were noted, and 50% of the 12 evaluable patients exhibited stable disease. This phase indicated strong pharmacokinetic properties and effective target interaction, with evidence of T cell proliferation in patients receiving doses within the therapeutic range. Looking ahead, BioInvent plans to launch a Phase 2a study for BI-1910 as a single agent in the first half of 2025, focusing on various tumor types, including hepatocellular carcinoma (HCC).

Simultaneously, BioInvent is launching Phase 1 trials of BI-1910 in conjunction with pembrolizumab, progressing with initial patient enrollment and dose escalation. CEO Martin Welschof expressed optimism about these developments, emphasizing TNFR2's potential as an immune checkpoint and reiterating the company's commitment to developing innovative cancer treatment options with both BI-1910 and BI-1808.

The company has previously shared encouraging results from BI-1808's monotherapy trials, with a substantial portion of patients experiencing partial responses. This progress is most notable in patients with cutaneous T cell lymphoma (CTCL) who had previously failed standard treatments. These responses have not only persisted but deepened over time, leading to increased patient enrollment and the establishment of new clinical sites. Data from earlier studies of BI-1808 indicated a mix of complete and partial responses along with stable disease in a subset of patients.

BioInvent is also pursuing Phase 2a trials to evaluate BI-1808 with pembrolizumab, focusing on ovarian cancer, among other types. Results from these ongoing trials are expected in the latter half of 2025.

BI-1910 represents a differentiated approach compared to BI-1808. Both antibodies stand out for potentially being best-in-class, selected from a pool of candidates through BioInvent's proprietary F.I.R.S.T™ technology platform. This novel method supports the identification of effective antibodies against specific targets, thereby enhancing the company’s pipeline for clinical development.

The Phase 1/2a study for BI-1910 aims to assess its safety, tolerability, and potential efficacy in patients with advanced solid tumors. The research is structured to analyze BI-1910 both as a standalone treatment and in combination with pembrolizumab.

BI-1808 is another promising candidate from BioInvent, targeting solid tumors and certain blood cancers. The ongoing Phase 2 study has shown that BI-1808, as a standalone agent, is well-tolerated and effective, while also demonstrating promising results when paired with pembrolizumab in Phase 1 studies. The Phase 2a trials for BI-1808 are exploring its efficacy in a larger patient cohort, expanding the focus to include ovarian cancer, various tumor types, and T cell lymphomas.

BioInvent International AB is at the forefront of developing groundbreaking immuno-modulatory antibodies for cancer treatment. With multiple clinical programs in progress, the company continues to leverage its proprietary technology to identify and develop novel therapeutic candidates. Through strategic collaborations and licensing agreements, BioInvent is poised to enhance its clinical pipeline and offer new treatment solutions for cancer patients worldwide.