Alligator Bioscience released positive data from its Phase Ib/II OPTIMIZE-1 study (NCT04888312) investigating its pancreatic cancer monoclonal antibody therapy, mitazalimab.

The Sweden-headquartered company presented the Phase II readout at the American Society of Clinical Oncology Annual Meeting (ASCO 2024), publishing the data in the Lancet Oncology on 3 June. Patients who took mitazalimab in combination with mFOLFIRINOX, demonstrated a confirmed objective response rate (ORR) of 40.4% with a median overall survival (mOS) of 14.3 months. This was an improvement compared to historical data from treatment with mFOLFIRINOX where patients typically achieve a 31.6% ORR and a mOS of 11.1 months.

In an exclusive interview with Pharmaceutical Technology, Alligator CEO Dr Søren Bregenholt says: “We believe that adding three months to the overall survival is clinically meaningful. It is definitely meaningful for the patients, and it is also a differential that is approvable in almost all major territories.”

Bregenholt explains that for 80% of pancreatic cancer patients, the only option available for frontline and second-line treatment is chemotherapy. He adds that approved therapies are quite “mediocre” in terms of response rate and clinical benefit.

The US Food and Drug Administration (FDA) recently approved Ipsen Biopharmaceuticals’ chemotherapy combination, NALIRIFOX, for the first-line treatment of pancreatic cancer in February 2024. NALIRIFOX uses Onivyde (irinotecan liposome) with oxaliplatin, fluorouracil, and leucovorin to treat the diseases The regimen is the second US-approved Onivyde regimen for metastatic pancreatic adenocarcimoma with FOLFIRINOX receiving an approval over a decade ago. Bregenholt adds that treatment with mitazalimab has very few adverse reactions and side effects compared to the many commonly associated with the marketed chemotherapy combinations.

Mitazalimab is a CD40 agonist that treats pancreatic cancer by activating and proliferating memory T cells and enhancing the immune response. Bregenholt says that the company has begun to plan its Phase III trial for mitazalimab.

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“We expect to start the Phase III trial in the first half of next year,” he says.