Alligator Bioscience gains orphan designation for mitazalimab

Mitazalimab is a monoclonal antibody that has been created to sensitize tumours to chemotherapy

Alligator Bioscience has announced that the European Medicines Agency (EMA) has granted orphan designation for the company’s lead asset, mitazalimab, for the treatment of pancreatic cancer.

Mitazalimab is a monoclonal antibody targeting CD40 and has been created to sensitize tumours to chemotherapy while also inducing immune-mediated tumour killing by activating dendritic cells, B cells and macrophages.

At present, the drug is being evaluated in OPTIMIZE-1, a phase 2 multi-location, open-label trial to analyse efficacy and safety when combined with chemotherapy (mFOLFIRINOX) in previously untreated patients with metastatic pancreatic ductal adenocarcinoma.

In June, Alligator announced a second set of strong interim results from OPTIMIZE-1, during which mitazalimab combined with mFOLFIRINOX demonstrated a deepening of tumour reaction and an increase in objective response rate (ORR) to 57% (it was initially 52% ORR among the 23 patients involved).

To meet the criteria for the EMA’s orphan designation, a therapy must be delivered for the treatment, prevention or diagnosis of rare, life-threatening or chronically debilitating diseases that impact fewer than five in 10,000 individuals across the EU.

Treatments that qualify are eligible for financial and regulatory incentives that include ten years of marketing exclusivity throughout the EU after a product has been approved.

Søren Bregenholt, chief executive officer at Alligator Bioscience, reflected: “We are very pleased that the European Medicines Agency has granted orphan designation to our lead asset mitazalimab in the treatment of pancreatic cancer.”

He added: “It is our second orphan designation this year following the US Food and Drug Administration’s (FDA) decision to grant us ODD in May, meaning mitazalimab now has stronger commercial protection through market exclusivity in these two key markets. This latest designation adds to the momentum we are building in our efforts to bring this promising drug candidate to market.”

Earlier this year, the FDA provided orphan drug designation to mitazalimab for treating pancreatic cancer.