SystImmune is a clinical-stagebiopharmaceutical company dedicated to developing innovative cancer treatmentsusing its established drug development platforms, focusing on bi-specific,multi-specific antibodies, and antibody-drug conjugates (ADCs).
Patients are at the center of everything we do. We conduct clinical trials with the goal of delivering safe, effective, and transformative therapies to people affected by cancer and other serious diseases. Our aim is to achieve regulatory approvals so these treatments can be broadly accessible to those who need them most.
We work with urgency and dedication, knowing that many patients and families are waiting for new treatment options. Every day, we strive to translate scientific discoveries into therapies that can make a meaningful impact on people’s lives.
Expanded Access, sometimes referred to as “compassionate use”, is a potential pathway for patients with serious or life-threatening conditions to access investigational medicines outside of clinical trials when no comparable or satisfactory alternative therapy is available.
According to the U.S. Food and Drug Administration (FDA), Expanded Access may be appropriate when:
• The patient has a serious or immediately life-threatening disease or condition.
• No comparable or satisfactory alternative therapy exists to diagnose, monitor, or treat the disease or condition.
• The patient cannot enroll in a clinical trial.
• The potential benefit justifies the potential risks.
• Providing the investigational medicine will not interfere with ongoing clinical trials that could support the product’s
development or approval.
More information about Expanded Access in the U.S. is available on the FDA website: FDA Expanded Access.
SystImmune is committed to making our investigational medicines available in an equitable manner based on the emerging and appropriate characterization of the benefit/risk profile, with priority given to supporting ongoing clinical trials and development programs. At this time, we are unable to provide our investigational medicines through Expanded Access or Right to Try pathways. For patients seeking access to our investigational medicines prior to regulatory approval, participation in one of our clinical trials is the most appropriate pathway. Information about our ongoing studies can be found at clinicaltrials.gov. Additional details about Expanded Access programs are available through the Reagan-Udall Foundation’s Expanded Access Navigator.
If you have additional questions, please speak with your treating physician or contact SystImmune at [email protected].
