FDA Grants Fast Track to Immuneering's IMM-1-104 for First-line Pancreatic Cancer

Immuneering Corporation, a clinical-stage oncology company, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead clinical-stage program, IMM-1-104, for the treatment of pancreatic ductal adenocarcinoma (PDAC) as a first-line therapy. This follows a prior Fast Track designation for IMM-1-104 as a second-line treatment for PDAC patients who had not responded to one previous line of therapy.

IMM-1-104 is designed to offer universal-RAS activity through Deep Cyclic Inhibition of the MAPK pathway and is administered once daily in oral form. The Fast Track designation could potentially expedite IMM-1-104's path to FDA submission for treating PDAC, a particularly challenging form of cancer.

The company's Phase 2a clinical trial for IMM-1-104 features multiple study arms. These include arms for first-line pancreatic cancer patients in combination with chemotherapy, as well as arms for second-line pancreatic cancer patients, RAS-mutant melanoma, and RAS-mutant non-small cell lung cancer. Immuneering expects to share initial data from these various study arms in the second half of 2024.

Dr. Ben Zeskind, Co-founder and CEO of Immuneering, highlighted the significance of the Fast Track designation for both first and second-line pancreatic cancer treatments. He emphasized the potential to help a broader range of patients afflicted by one of the toughest cancers to treat. "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," Zeskind noted.

The Fast Track Designation program is aimed at facilitating the development and expediting the review process of drugs that have the potential to address serious conditions and meet unmet medical needs. An investigational drug with Fast Track status may have more frequent interactions with the FDA to discuss its development plan, and, if it meets relevant criteria, it may qualify for accelerated approval and priority review.

Immuneering Corporation is focused on developing and commercializing universal-RAS/RAF medicines for a broad population of cancer patients. Their approach aims to achieve universal activity through Deep Cyclic Inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells. In addition to IMM-1-104, the company's pipeline includes IMM-6-415, another oral Deep Cyclic Inhibitor currently in Phase 1/2a trials targeting advanced solid tumors with RAS or RAF mutations, and several early-stage programs.

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