Expanded Access Policy

“Expanded Access” refers to the use of an investigational product outside of a clinical trial for potential treatment of a serious or life-threatening condition (also known as Compassionate Use) by the US Food and Drug Administration (FDA). Outpace Bio is developing autologous gene-modified cell therapy products for patients with solid tumors. Consistent with our commitment to bring innovative, safe, and effective products to patients, Outpace Bio is focused on conducting the clinical trials necessary to gain the data needed to support regulatory approvals to enable access to our products as quickly and safely as possible. Participation in one of our clinical trials is the best and preferred route to access these investigational products.

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Outpace Bio believes that access to investigational therapies should be limited to controlled clinical trials until such time as the safety, tolerability and effectiveness of a therapy has been determined and confirmed by regulatory authorities. Pre-approval access outside of a controlled clinical trial may interfere with the conduct of our ongoing trials and may also disrupt the progress of our development programs, which would, in turn, delay access to many other patients in need. For all the foregoing reasons, Outpace Bio does not currently have any active Expanded Access protocols, nor do we currently provide access to our investigational products on an Expanded Access basis. We encourage patients interested in our investigational products to learn more about our ongoing studies by visiting here.

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If you are a patient with additional questions, please speak with your treating physician. If you are a health care provider who is interested in learning more about one of our investigational therapies, or a physician with questions about participation in one of our clinical trials, please submit a request to clinicaltrials@outpacebio.com.

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In the event Outpace Bio decides to consider making one or more of its investigational candidates available for patients who have a serious or life-threatening condition through an Expanded Access program, general criteria to be considered may include the availability of alternative products, the potential risks and benefits to the patient, supply manufacturability, and potential interference with Outpace Bio ongoing clinical trials. All requests would be evaluated on a case-by-case basis in a fair and equitable manner. This policy shall not serve as a guarantee of access to any specific investigational candidates by any individual patient. As authorized by the 21st Century Cures Act, Outpace Bio may revise this Expanded Access Policy at any time.