Expanded Access / Compassionate Use Policy
Immunicum AB is committed to discovering and developing novel safe and effective cell therapy products for solid tumors to improve survival outcomes and quality of life by priming the patient’s own immune system to fight cancer.
The following is Immunicum’s global expanded access policy for investigational therapies, e.g. ilixadencel (INN), that are intended to treat serious diseases.
Expanded Access / Compassionate Use
Currently, Immunicum does not have any investigational cell therapy products available for Expanded Access (also known as “Compassionate Use” or “Named Patient Permission”).
Immunicum recognizes the importance of early access. Per regulatory requirements, expanded access program must not interfere with the clinical development of the drug; it is our priority therefore, to demonstrate the safety and effectiveness of our cell therapy products in controlled clinical studies as speedily as possible, in order to obtain global regulatory approvals and then make them commercially available to all appropriate patients.
Immunicum is currently unable to offer expanded access and we believe that participation in one of our clinical trials is the most appropriate way to access our investigational therapies.
Clinical trials are performed in order to evaluate the safety and efficacy of investigational new therapies in specific populations. Participation in clinical trials authorized by the U.S. Food and Drug Administration (FDA), European or other national regulatory authorities is the best way for patients to access investigational therapies for their diseases.
Treating physicians, patients and/or caregivers interested in learning more about Immunicum’s investigational cell therapies currently undergoing clinical studies can find more information on the company’s website, linked here.
Clinicaltrials.gov contains additional information about these studies.
For physicians or healthcare providers interested in more information, please contact email@example.com.
This policy by Immunicum shall not serve as a guarantee of access to any specific investigational cell therapy by any individual patient. As authorized by and in accordance with the 21st Century Cures Act, Immunicum may revise this posted expanded access policy at any time.