Immunofoco is a clinical-stage biotech company, devoted to bringing revolutionary immune cell therapies to patients with solid tumors worldwide. The company was established in September 2020 in Zhangjiang, Shanghai, by a team of renowned scientists and industry experts.
To ensure the highest scientific and medical confidence in our products, Suzhou Immunofoco Bio (Immunofoco thereafter) believes that investigational drugs should be studied within clinical trials designed to obtain data on safety and efficacy that may be used to support approval of the product, enabling wide accessibility to appropriate patients. Investigational medicines are drugs or biologics that have not been approved or cleared by regulatory authorities.
Expanded Access, which is sometimes known as “compassionate use”, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational therapy for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. The U.S. FDA advises that Expanded Access may be appropriate when all the following apply:
• Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• Patient enrollment in a clinical trial is not possible.
• Potential patient benefit justifies the potential risks of treatment.
• Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication
For more information about expanded access in the U.S., please visit the FDA website at https://www.fda.gov/news-events/public-health-focus/expanded-access.
Immunofoco seeks to retain the ability to manufacture and supply investigational medicines in a fair and equitable manner that assures adequate supply for ongoing clinical trials and development programs. Hence, at this time, Immunofoco is not making any of its investigational medicines available on an Expanded Access basis prior to regulatory approval anywhere in the world. For patients seeking access to our investigational medicines before they are approved by a regulatory authority, participation in one of Immunofoco’s clinical trials is the most appropriate way to access these investigational medicines. To learn more about available clinical trials please visit https://clinicaltrials.gov and search by company, disease or medicine.
If you have additional questions, please speak with your physician. You may also submit questions or seek more information directly from Immunofoco at the email address regulatory. submission@immunofoco.com. Immunofoco expects to acknowledge receipt of inquiries within five business days.
Consistent with the 21st Century Cures Act, Immunofoco may revise this expanded access policy at any time and the posting of the policy by Immunofoco shall not serve as a guarantee of access to any specific investigational drug for any patient.
