BioInvent International (BINV) Aktiespararna Digital temakväll - Life Science summary

Pipeline and mechanism

• Four clinical trials underway across BI-1808 and BI-1206; discovery, manufacturing, formulation and clinical development are conducted in-house.

• BI-1808 targets TNFR2; its proposed mechanism depletes regulatory T cells, activates myeloid cells and recruits CD8-positive T cells into tumors.

• BI-1808 showed single-agent activity in solid tumors and synergy with anti-PD-1 in preclinical work; the ESMO combination poster received a Best Poster Award.

BI-1808 in recurrent ovarian cancer

• In 34 evaluable patients with recurrent ovarian cancer, median four prior treatment lines, BI-1808 plus pembrolizumab showed 25% ORR versus 8% for pembrolizumab alone.

• PFS was 10.3 months by iRECIST and 4.1 months by RECIST; the study population was more heavily pretreated than the KEYNOTE-B96 population.

• Safety was described as excellent for both BI-1808 monotherapy and the pembrolizumab combination; monotherapy ORR was 6%.

• A comparison adding BI-1808 to pembrolizumab plus paclitaxel, the recently approved standard of care, is planned to start in early 2027; first data are expected in H2 2027.

• Fast Track designation was granted; the next development plan includes seeking Breakthrough Therapy Designation and potentially moving to a pivotal study.

Other programs and commercial opportunity

• In CTCL, BI-1808 showed objective responses, disease control above 90% and long-lasting complete responses; dose optimization is ongoing, with the combination adding little and future work focused on monotherapy.

• Final CTCL dose-optimization data are expected in H1 2027; six-prior-treatment PTCL and CTCL cases also showed responses in the presentation.

• BI-1206 is being developed in non-Hodgkin lymphoma, NSCLC and uveal melanoma; a first-half 2027 readout is expected from the phase II-A first-line study with KEYTRUDA.

• A conservative recurring ovarian cancer peak-sales estimate is SEK 1.7bn, based on EVERSANA research; CTCL was described as a separate market of roughly half a billion.