With the mission of “the right activation of the right immune cells to promote lifelong protection against cancer”, Marengo is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness. Consistent with this mission, we bring innovative medicines to patients with serious or life-threatening illnesses or conditions, focusing on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. We believe this approach will serve patients who could be helped by the therapies we are developing.

At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. In such circumstances, a patient’s physician may request an investigational drug for that patient to be treated outside of a clinical trial. This request for use of an investigational drug is known as “expanded access” or “compassionate use” and must meet certain criteria set forth by US FDA and other regulatory authorities (https://www.fda.gov/news-events/public-health-focus/expanded-access). Different from a clinical trial whose primary goal is to obtain data on safety and efficacy of an investigational drug, the primary objective of an expanded access is to provide the investigational drug for a patient’s treatment.

However, Marengo does not offer an expanded access program at this time. At this stage of our clinical development, we believe that the most appropriate way to offer patients’ access to our investigational product is through participation in our ongoing clinical trials. More information about Marengo’s clinical trial is available at www.clinicaltrials.gov under NCT number NCT05592626. We may revise our expanded access policy at any time and post it accordingly. If you have any questions about our expanded access policy, please contact info@marengotx.com.