Alligator Bioscience obtains FDA approval to develop new bladder cancer therapy

Lund-based biotech company Alligator Bioscience has received clearance from the US Food and Drug Administration (FDA) to advance the development of a new therapy for bladder cancer.

The company will initiate the OPTIMIZE-2 trial to evaluate the implementation of its proprietary drug, mitazalimab, in urothelial carcinoma, the most common type of bladder cancer.

Mitazalimab is a stimulatory antibody that targets CD40, a receptor in the body’s immune system responsible for detecting cancer. By activating the CD40 in dendritic cells, the immune system can attack cancer cells more effectively.

The company utilises its “unique” Fragment INduced Diversity (FIND) technology to optimise mitazalimab. The FIND technology improves the drug’s binding ability, allowing clinicians to use very low doses to achieve desirable results.

CEO Søren Bregenholt said the company had analysed the clinical activity of mitazalimab in combined application with conventional chemotherapy during the OPTIMIZE-1 phase. The preliminary study showed that mitazalimab could provide more benefits than standardised care.

“The experiences and data from the mitazalimab program thus far was used to de-risk and enhance the design of OPTIMIZE-2, and we strongly believe in mitazalimab’s potential to benefit patients with urothelial carcinoma that has become refractory to prior checkpoint inhibitor-therapy,” Bregenholt said.

The OPTIMIZE-2 study will be conducted in 15 to 20 locations across the US and Europe. Assessors will apply the combination of mitazalimab and the PD-1 inhibitor in adult urothelial carcinoma patients that have undergone PD-(L)1 therapy.

After the conclusion of OPTIMIZE-2, Alligator Bioscience will expand patient enrolment to allow a primary analysis of the drug’s safety and efficacy.

Other drug candidates in development

In addition to mitazalimab, Alligator Bioscience is developing other novel drug candidates for tumour-related diseases. Alligator Bioscience co-develops ALG.APV-527, a new tumour-binding drug, with Aptevo Therapeutics using its Neo-X-Prime technology.

The company also works with Finland’s Orion Corporation to develop novel drug candidates based on its RUBY biospecific platform.