Acrivon Expanded Access Policy
Acrivon Therapeutics (Acrivon) is a clinical stage biopharmaceutical company developing precision oncology medicines that positively impact the lives of cancer patients. Acrivon’s proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3, enables the creation of drug-specific proprietary OncoSignature® companion diagnostics that are used to identify the patients most likely to benefit from Acrivon’s drug candidates.
Under a provision referred to as “Expanded Access” by the U.S. Food and Drug Administration (“FDA”) where enrollment into a clinical trial is not an option, and where all currently available treatment options have been exhausted, an investigational medicine may be provided prior to regulatory approval or commercial availability.
The clinical development and regulatory approval processes are important for the advancement of new medicines as they ensure there is sufficient data to support the safety and efficacy of investigational medicines while in a carefully monitored clinical trial setting. In addition to evaluating its investigational products, Acrivon’s clinical studies are simultaneously testing the corresponding companion diagnostic OncoSignature test to predict patient responders to its medicines. For these reasons, Acrivon does not presently offer an expanded access program; however, we may consider, on a case-by-case basis, to make one or more of our investigational medicines available through an Expanded Access Program in the future.
Our clinical trials represent the best way to access Acrivon’s investigational medicines, as they provide the most effective method for assessing how our investigational medicines in conjunction with our companion diagnostic may impact cancer treatment. We encourage patients to speak with their treating physicians about participating in a clinical trial, when possible.
You can find information about Acrivon’s ongoing clinical trials by accessing https://clinicaltrials.gov. If you have additional questions, please speak with your treating physician or contact Acrivon at ExpandedAccess@Acrivon.com.
As authorized by the 21st Century Cures Act, Acrivon may revise this Expanded Access Policy at any time. The posting of this policy by Acrivon shall not serve as a guarantee of access to any specific investigational medicine by any individual patient.