Cantargia AB announced that the FDA has granted Orphan Drug Designation in the US to nadunolimab (CAN04) for the treatment of pancreatic cancer. This provides access to various incentives in the continued clinical development of nadunolimab in pancreatic cancer.
The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody nadunolimab 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, which accounts for more than 90% of all cases of pancreatic cancer.
The Orphan Drug Designation Program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the US. Orphan Drug Designation qualifies sponsors for incentives, including tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval. More information about rare diseases and the Orphan Drug Designation Program is available on www.fda.gov.
Nadunolimab is currently evaluated in ongoing clinical trials for treatment of PDAC. In CANFOUR, a phase I/IIa study, nadunolimab is investigated in approximately 70 patients with gemcitabine and nab-paclitaxel as first line combination in advanced PDAC, and in the phase Ib trial CAPAFOUR together with FOLFIRINOX as first line therapy in patients with metastatic PDAC. Interim efficacy data from 33 PDAC patients in the CANFOUR study show that the nadunolimab combination therapy results in durable responses or pseudoprogression, leading to prolonged progression-free survival (iPFS) and overall survival (OS) compared to historical control data. Preparations are ongoing for late-stage development in PDAC, to be initiated during 2022.
"The Orphan Drug Designation by FDA provides several strategic advantages and is a valuable step forward in the development of nadunolimab. The designation also confirms Cantargia's strong commitment to provide new effective treatment options to patients with pancreatic cancer." said Göran Forsberg, CEO of Cantargia.
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