Pharma Focus Asia

Immuneering's IMM-1-104 Receives FDA Fast Track Designation for Pancreatic Cancer

Wednesday, February 21, 2024

Immuneering Corporation (Nasdaq: IMRX) has recently announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for its lead clinical-stage program, IMM-1-104, targeting patients with pancreatic ductal adenocarcinoma (PDAC) who have failed one line of treatment. IMM-1-104 aims to provide universal-RAS activity through deep cyclic inhibition of the MAPK pathway with once-daily oral dosing.

"We welcome FDA’s decision to grant Fast Track designation for IMM-1-104. Our Phase 1/2a study is designed to evaluate IMM-1-104 in pancreatic cancer, as well as a number of other tumor types associated with the RAS pathway. We look forward to a data-rich 2024 as we plan to provide multiple readouts from our study this year," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering.

Vincent Chung, M.D., FACP, Professor, Department of Medical Oncology and Therapeutics Research, is principal investigator of the Phase 1/2a clinical study with IMM-1-104 at City of Hope, one of the largest cancer research and treatment organizations in the United States.

“The FDA’s decision reinforces the importance of developing effective, novel treatments to improve the health outcomes of patients with pancreatic ductal adenocarcinoma. The development of well-tolerated oral medicines would improve the lives of these patients. City of Hope offers many clinical trials testing innovative treatments for people with pancreatic cancer," Chung said.

Fast Track Designation is a program designed to facilitate the development and expedite the review of medicines with the potential to treat serious conditions and fulfill an unmet medical need. An investigational medicine that receives Fast Track Designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, may be eligible for accelerated approval and priority review.



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