BioInvent International AB announced positive Phase 1 data for its investigational antibody BI-1206 in combination with MSD's pembrolizumab (KEYTRUDA®) for treating solid tumors. The completed dose escalation study in heavily pre-treated patients showed encouraging clinical activity, with one complete response in metastatic cutaneous melanoma, one long-lasting partial response in metastatic uveal melanoma, and 11 patients achieving stable disease out of 36 evaluable patients.
The combination therapy demonstrated a favorable safety profile, enabling continued dose expansion to explore higher dose levels. The study evaluated both intravenous and subcutaneous formulations of BI-1206, with the company's strategy focusing on transitioning to subcutaneous administration to allow slower systemic entry and prolonged target engagement.
Clinical Activity and Safety Profile
Among the patients achieving stable disease, one patient with long-lasting metastatic melanoma who had previously progressed on nivolumab treatment maintained stable disease throughout the two-year study duration with the BI-1206 and pembrolizumab combination. The well-tolerated safety profile supports the potential for higher dose exploration in future studies.
The Phase 1 data corroborate preclinical findings suggesting that BI-1206 significantly enhances the effectiveness of anti-PD-1 therapy. Based on this evidence, MSD and BioInvent have agreed to further investigate the synergies between BI-1206 and pembrolizumab in earlier treatment lines.
Planned Phase 2a Expansion
BioInvent plans to initiate Phase 2a expansion cohorts during the second half of 2025, focusing on treatment-naïve patients with advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma. The Phase 2a study will consist of two parts: a signal seeking phase and a dose optimization phase.
In the signal seeking phase, up to 30 NSCLC patients and 12 uveal melanoma patients will receive fixed doses of BI-1206 and pembrolizumab every 21 days for three treatment cycles. Patients demonstrating clinical benefit by Week 9 can continue therapy for up to 32 additional cycles, while those with disease progression will not proceed further.
Addressing Treatment Resistance
NSCLC represents the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases. While checkpoint inhibitors are widely accepted and can produce durable responses in NSCLC, the overall response rate remains low, rarely exceeding 25%.
A common resistance mechanism in cancer involves the binding and degradation of therapeutic antibodies against PD-1, such as pembrolizumab, by FcγRIIB expressing immune cells. Based on preclinical and early clinical data, BioInvent believes that resistance or lack of response to anti-PD-1 treatment may be overcome by FcγRIIB blockade, particularly in subjects who have never been exposed to anti-PD-1 agents.
Company Leadership Perspective
"We are highly encouraged by the clinical responses emerging from our solid tumor program which support the broad utility of combining subcutaneous BI-1206 with pembrolizumab in a range of solid tumors," said Martin Welschof, Chief Executive Officer of BioInvent. "The strong signals we have observed in heavily pre-treated patients support the idea that BI-1206 could be used to improve the activity of pembrolizumab across different tumor types, and we therefore look forward to initiating our Phase 2a study in the high unmet medical need of non-small cell lung cancer."
About BI-1206
BI-1206 represents one of BioInvent's lead drug candidates, developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab. The drug candidate is being evaluated in two separate clinical programs: one for solid tumors and another for non-Hodgkin's lymphoma treatment.
The ongoing Phase 1/2a study with BI-1206 in combination with pembrolizumab in heavily pre-treated patients with solid tumors is registered under NCT04219254. BioInvent is a clinical-stage biotech company focused on discovering and developing novel immune-modulatory antibodies for cancer therapy, with five drug candidates currently in six ongoing clinical programs in Phase 1/2 trials.
