Cantargia has announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has issued a positive opinion for orphan designation of nadunolimab (CAN04) for treatment of pancreatic cancer.

The European Commission is now expected to grant the orphan designation. This provides a range of incentives in the continued clinical development of CAN04 in pancreatic cancer, states the company. The opinion is forwarded to the European Commission which is expected to grant the orphan designation within 30 days. The positive opinion is based on data from the ongoing CANFOUR trial, a phase I/IIa study where CAN04 is investigated in patients with advanced PDAC as first line combination with gemcitabine and nab-paclitaxel. CAN04 was granted US Orphan Drug Designation for treatment of pancreatic cancer by the Food and Drug Administration (FDA) in September 2021.

“Orphan designation provides a large number of opportunities for nadunolimab. We intend to take advantage of those in our strong commitment to advance the development towards new treatment alternatives in pancreatic cancer,” says Göran Forsberg, CEO of Cantargia.

CAN04

The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody CAN04 is Cantargia’s lead program and is investigated in multiple clinical trials evaluating combination with chemotherapy regimens in various forms of cancer, including pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer.

CAN04 is currently evaluated in two ongoing clinical trials for treatment of PDAC. In parallel with the CANFOUR study, CAN04 is also investigated in combination with FOLFIRINOX as first line therapy in patients with metastatic PDAC in the phase Ib trial CAPAFOUR. Interim efficacy data from 33 PDAC patients in CANFOUR show that the CAN04 combination therapy results in durable responses or pseudoprogression, leading to both prolonged progression-free survival and median overall survival compared to historical control data. Preparations are ongoing for late-stage development in PDAC, to be initiated during 2022.

Photo of Göran Forsberg: Håkan Sandbring