24/7 Market News- FDA Grants Fast Track Designation for Immuneering’s IMM-1-104 PDAC Treatment

August 1, 2024

DENVER, Colo., Aug 01, 2024 (247marketnews.com)- Immuneering Corporation (Nasdaq:IMRX) stated that the U.S. Food and Drug Administration (FDA) granted its lead clinical-stage program, IMM-1-104, as a first-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC), fast track designation.

The Company expects initial data from multiple arms of its Phase 2a clinical trial later this year.

“First-line pancreatic cancer patients are eligible and actively enrolling in our Phase 2a study, in two arms evaluating IMM-1-104 in combination with chemotherapy,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “With Fast Track designation now granted for IMM-1-104 in both first and second-line pancreatic cancer, we have the potential to help a broader population of patients impacted by one of the most difficult to treat cancers. Our Phase 2a study also includes an arm evaluating IMM-1-104 as monotherapy in first and second-line pancreatic cancer patients, along with monotherapy arms focused on RAS mutant melanoma and RAS mutant non-small cell lung cancer. We look forward to sharing initial data from multiple arms of the study this year.”

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