Immuneering Corporation announced on October 15, 2024, that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for its lead clinical-stage program, IMM-1-104, for the treatment of pancreatic cancer. This designation is a critical regulatory milestone for the company's therapeutic candidate.
The Orphan Drug Designation is granted to drugs and biologics intended to treat rare diseases or conditions that affect fewer than 200,000 people in the United States. This status provides various development incentives, including tax credits for clinical research costs, user fee waivers, and a potential seven years of market exclusivity upon regulatory approval.
This designation follows Immuneering's recent announcement of positive initial Phase 2a data for IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer patients, which included observations of complete and partial responses. The ODD is expected to help advance the development of IMM-1-104 as a potential new therapy for pancreatic cancer patients.
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