BioInvent begins Phase 1b/2a trial of BI-1607 with ipilimumab and KEYTRUDA in advanced melanoma patients

BioInvent International AB, a company based in Sweden, has taken a significant step forward in cancer immunotherapy by enrolling the first patient in a new clinical trial. This trial, known as a Phase 1b/2a study, is designed to assess the safety and anti-cancer effectiveness of their innovative antibody, BI-1607. It will be tested in combination with ipilimumab and KEYTRUDA® (pembrolizumab), in patients dealing with advanced melanoma that cannot be surgically removed or has spread to other parts of the body.

The study is structured to include four different groups, where two dosage levels of BI-1607 will be tested. This will be paired with two dosages of the existing CTLA-4 antibody, ipilimumab. The approved dosage of ipilimumab for melanoma treatment is 3 mg/kg, but a lower dosage of 1 mg/kg will also be evaluated. Both will be combined with a standard 200 mg dosage of pembrolizumab in patients previously treated with other anti-PD-1/L1 therapies.

The trial aims to include around 35 participants across multiple locations in the UK, Germany, and Spain, with the first results anticipated in the latter half of 2025. This follows a clinical supply agreement established in July 2024 between BioInvent and MSD International Business GmbH, a subsidiary of Merck & Co., Inc., to secure KEYTRUDA for the study.

Martin Welschof, CEO of BioInvent, expressed enthusiasm about the preliminary results from the BI-1607 program, highlighting its safety and early signs of effectiveness when previously tested in combination with trastuzumab. He noted that this preclinical data supports the potential for BI-1607 to enable reduced dosing of ipilimumab, which may improve both tolerability and effectiveness. The company is eager to further investigate the promising potential of this combination.

BI-1607 represents an engineered antibody designed to boost the efficacy of existing cancer therapies and tackle resistance issues associated with them. In December 2023, BioInvent shared promising findings from an earlier Phase 1 study where BI-1607 was tested with trastuzumab in patients with advanced HER2+ solid tumors. The treatment was well-tolerated, with no serious side effects attributed to BI-1607, and some patients experienced stabilization of their disease. Earlier in 2021, preclinical studies showed BI-1607's capacity to overcome resistance to CTLA-4-based therapies.

BioInvent, listed on Nasdaq Stockholm, specializes in discovering and developing new immune-modulatory antibodies for cancer treatment. The company has five drug candidates undergoing clinical trials in various stages for both blood cancers and solid tumors. Their proprietary F.I.R.S.T™ technology platform plays a crucial role in identifying targets and corresponding antibodies, fostering the development of promising therapeutic candidates. This platform also presents opportunities for partnerships and licensing with major pharmaceutical entities.

BioInvent's revenue is generated through research collaborations, licensing agreements with top pharmaceutical companies, and the production of antibodies for external clients, facilitated by their integrated manufacturing unit. The company continues to build a robust pipeline of potential cancer therapies, driven by their innovative research and development efforts.