BI-1206 is a high-affinity monoclonal antibody that selectivity binds to FcγRIIB (CD32B), the only inhibitory member of the FcγR family. The ongoing clinical program is based on BioInvent’s preclinical data demonstrating the ability of BI-1206 to address an important mechanism of resistance to PD-1 inhibition, providing a way to enhance anti-tumor immune responses in patients with solid tumors.
BI-1206 targets an important mechanism of resistance to PD-1 inhibition
STATUS
Clinical Phase 1/2a study with BI-1206 in combination with pembrolizumab (NCT04219254) ongoing
Based on Phase 1 data in solid tumors where BI-1206 enhanced the effect of anti-PD-1, MSD and BioInvent agreed to further investigate the synergies be tween BI-1206 and pembrolizumab in earlier lines of treatment. The ongoing Phase 2a study of BI-1206 in combination with pembrolizumab is performed in treatment-naïve patients with NSCLC and uveal melanoma.
STATUS
The ongoing Phase 2a clinical trial is evaluating BI-1206 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembroli zumab) in patients with advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma in the first line setting. As presented at a previous ASCO meeting, in Phase 1, BI-1206 was deemed to be safe and well-tolerated and demonstrated promising clinical activity in heavily pre-treated patients, with one complete response (CR), one long-lasting partial response (PR), and 11 patients with stable disease (SD) out of 36 evaluable patients. All patients had progressed after previous treatments with anti-PD-1/L1 agents. The subcutaneous formulation provided slower systemic entry and prolonged time on tar get while improving safety and tolerability.
NSCLC is the most common type of lung cancer, accounting for about 85 percent 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 percent. A common resistance mechanism in cancer is the binding and degradation of therapeutic antibodies against PD-1 such as pembrolizumab by FcyRIIB expressing immune cells. Therefore, based on preclinical and early clinical data, the company believes that resistance or lack of response to anti-PD-1 treatment may be overcome by FcyRIIB blockade in particular in subjects who have never been exposed to anti PD-1 agents.
STUDY DESIGN (NCT04219254)
The ongoing Phase 2a trial will evaluate the safety and efficacy of BI-1206 in combination with pembrolizumab in patients with advanced or metastatic NSCLC and uveal melanoma. Patients will be enrolled at sites in Georgia, Germany, Poland, Rumania, Spain, Sweden and the US, with first data expected in H2 2026. The trial will be conducted in two parts. In the first part, or signal-seeking phase, up to 30 NSCLC and 12 uveal melanoma patients will receive BI-1206 and pembrolizumab every 21 days for up to 2 years. Following the signal-seeking phase, the study will proceed to a dose optimization phase, designed to refine the dosing strategy to maximize both efficacy and tolerability of the combination. During dose optimization, patients will be randomized to receive a higher or a lower dose of BI-1206. A third cohort will then receive pembrolizumab alone.
OUT-LICENSING AND PARTNERING
In December 2019 BioInvent entered into a clinical trial collaboration and supply agreement with MSD, a tradename of Mer ck & Co., Inc., Rahway, NJ., USA, to evaluate the combination of BioInvent’s BI-1206 and MSD’s anti-PD-1 therapy, KEYTRUDA (pem brolizumab) in a Phase 1/2a clinical trial for patients with solid tumors. Under the agreement, MSD supplies KEYTRUDA.
Read more about the ongoing Phase 1/2a study
OUT-LICENSING AND PARTNERING
In December 2019 BioInvent entered into a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ., USA, to evaluate the combination of BioInvent’s BI-1206 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in a Phase 1/2a clinical trial for patients with solid tumors. Under the agreement, MSD supplies KEYTRUDA.