Expanded Access Policy

Expanded Access Policy

The company's lead candidate is nadunolimab, which is currently being developed for patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC) with high expression levels of IL1RAP. Nadunolimab will be given in combination with gemcitabine and nab-paclitaxel. This development is being conducted through clinical trials. If successful, these may provide the basis for submissions for drug approval to regulatory authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

At Cantargia AB we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make nadunolimab available to patients as quickly as possible. As such, we believe participation in our clinical trial is the most appropriate way to access our new treatments at this early stage of development.

Details about our clinical trials, including eligibility requirements for participating in ongoing or planned studies are published in public databases such as clinicaltrials.gov and euclinicaltrials.eu.

We recognize that there may be patients with PDAC or a related condition for whom participation in a clinical trial may not be an option. Where allowed, such patients may be interested in seeking access to investigational drugs before the regulatory approval of a drug via compassionate use or expanded access. Providing access outside of controlled clinical trials at this time could jeopardize the conduct of these trials and thus even prevent or delay access to nadunolimab for other patients in need. Also, in consideration of the currently available data on safety and efficacy of nadunolimab, it is not appropriate to provide access to nadunolimab outside of our clinical trials at this early stage of development.

This policy may be reviewed and amended in the future. For additional information about this policy, please contact info@cantargia.com. We aim to provide responses within one week.