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Cantargia AB: Cantargia receives positive EMA opinion for orphan designation of nadunolimab for treatment of pancreatic cancer
Luk
Cantargia AB
14.10.2021 08.30·
Cision
Cantargia AB today 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.
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.
The COMP at the EMA has issued a positive opinion for orphan designation of CAN04 for treatment of pancreatic cancer. 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.
The EMA orphan designation is designed to encourage the development of new treatments for life-threatening or chronically debilitating conditions that are rare and affect not more than five in 10,000 people in the EU. For a therapy to qualify for orphan designation in the EU, one of several requirements is that, unless no satisfactory method of treatment of the condition concerned has been authorized, the therapy must be of significant benefit to those affected by the condition. Therapies that meet the EMA's orphan designation criteria qualify for several incentives, including 10 years of market exclusivity, protocol assistance, and potentially reduced fees for regulatory activities. More information is available at www.ema.europa.eu/en/human-regulatory/research-development/orphan-designation-research-development.
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.
"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.", said Göran Forsberg, CEO of Cantargia.
Luk
Cantargia AB
14.10.2021 08.30·
Cision
Cantargia AB today 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.
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.
The COMP at the EMA has issued a positive opinion for orphan designation of CAN04 for treatment of pancreatic cancer. 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.
The EMA orphan designation is designed to encourage the development of new treatments for life-threatening or chronically debilitating conditions that are rare and affect not more than five in 10,000 people in the EU. For a therapy to qualify for orphan designation in the EU, one of several requirements is that, unless no satisfactory method of treatment of the condition concerned has been authorized, the therapy must be of significant benefit to those affected by the condition. Therapies that meet the EMA's orphan designation criteria qualify for several incentives, including 10 years of market exclusivity, protocol assistance, and potentially reduced fees for regulatory activities. More information is available at www.ema.europa.eu/en/human-regulatory/research-development/orphan-designation-research-development.
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.
"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.", said Göran Forsberg, CEO of Cantargia.
