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

BioInvent International, a biotechnology firm based in Lund, Sweden, has announced promising outcomes from the initial phase of clinical testing for its new anti-TNFR2 antibody, BI-1910. This development strengthens the potential of TNFR2 as an innovative checkpoint in cancer immunotherapy. The company's announcement is a significant milestone in its efforts to advance cancer treatment options.

The Phase 1 Part A study, which involved dose escalation of BI-1910 as a single agent, has reached a biologically active dose without any significant adverse effects. Of the 12 patients evaluated, half exhibited stable disease, suggesting a favorable safety profile and potential therapeutic efficacy. The findings also indicated strong pharmacokinetic data and marked target engagement, evidenced by T cell proliferation in patients within the target dose range.

Following the successful completion of Phase 1 Part A, BioInvent has launched Phase 1 Part B, which combines BI-1910 with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). This combination aims to enhance the therapeutic effects by leveraging the immune-modulatory properties of both treatments. The initiation of this phase marks a critical step in exploring the combined therapeutic potential of these agents.

BioInvent is simultaneously advancing BI-1808, another anti-TNFR2 antibody. Preliminary data from BI-1808’s monotherapy study showed promising results, with three out of four evaluable patients in the cutaneous T cell lymphoma (CTCL) cohort experiencing partial responses. This indicates the potential of BI-1808 to elicit a meaningful clinical response in patients who have not responded to standard treatments. The continued improvement of a patient in this cohort, as reported in December 2024, underscores the antibody's potential effectiveness.

The parallel development of BI-1910 and BI-1808 underscores BioInvent's commitment to exploring TNFR2 as a target for cancer immunotherapy. The progress of these antibodies supports BioInvent's strategic focus on developing new treatment solutions for cancer patients. Both antibodies are being evaluated for their potential as standalone treatments and in combination with pembrolizumab, offering a dual approach to targeting cancer cells.

The promising early results from these studies have propelled BioInvent to plan Phase 2a trials for BI-1910 as a single agent in various tumor types, including hepatocellular cancer, anticipated to begin in the first half of 2025. Meanwhile, the Phase 2a combination trial of BI-1808 with pembrolizumab is already underway, targeting ovarian cancer patients, with further data expected in the latter half of 2025.

BioInvent's proprietary F.I.R.S.T™ technology platform plays a crucial role in the development of these novel antibodies, enabling the identification of promising immune-modulatory candidates. This technology not only fuels BioInvent’s clinical pipeline but also provides opportunities for partnerships and licensing agreements with major pharmaceutical companies.

As BioInvent continues its clinical evaluations, the company remains focused on delivering innovative cancer therapies. The progress of BI-1910 and BI-1808 reflects BioInvent’s commitment to providing new hope for cancer patients through advanced immunotherapy solutions.