Alligator Bioscience’s mitazalimab received orphan drug designation from the US FDA in May 2023 to treat pancreatic cancer. Credit: mi_viri / Shutterstock.com.

The European Medicines Agency (EMA) has granted orphan designation for Alligator Bioscience’s mitazalimab to treat patients with pancreatic cancer.

A lead asset of the company, mitazalimab is a monoclonal antibody that acts on CD40. 

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It is being analysed for safety and efficacy in a Phase II OPTIMIZE-1 clinical trial along with chemotherapy, mFOLFIRINOX, in previously untreated metastatic pancreatic ductal adenocarcinoma.

The second interim trial data reported in June 2023 showed that mitazalimab plus mFOLFIRINOX offered improved tumour response and an objective response rate (ORR) of 57%.

An interim ORR of 44% was observed in the full trial cohort of 57 patients. The company expects the figures to rise with further follow-up.

The treatment also offered a median duration of response (DoR) of 8.7 months, according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). 

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Alligator Bioscience CEO Søren Bregenholt stated: “We are very pleased that the European Medicines Agency has granted orphan designation to our lead asset mitazalimab in the treatment of pancreatic cancer. 

“It is our second orphan designation this year following the FDA’s decision to grant us ODD in May, meaning mitazalimab now has stronger commercial protection through market exclusivity in these two key markets.”

Mitazalimab received orphan drug designation from the US Food and Drug Administration (FDA) in May 2023 for pancreatic cancer.

In January 2023, Alligator Bioscience expanded an immuno-oncology research collaboration and licence agreement with Orion to discover and develop new bispecific cancer therapeutics.