FDA Fast Track for Immuneering’s Pancreatic Cancer Candidate

Clinical stage oncology company, Immuneering Corporation (Nasdaq: IMRX) has been granted Fast Track Designation by the FDA for its IMM-1-104, for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) who have failed one line of treatment.

“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.

Highlights

IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of the MAPK pathway with once-daily oral dosing.

The company said 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.

About Immuneering Corporation

Immuneering is a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy. The Company aims to achieve universal activity through deep cyclic inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells. Immuneering’s lead product candidate, IMM-1-104, is an oral, once-daily deep cyclic inhibitor currently in a Phase 1/2a study in patients with advanced solid tumors harboring RAS mutations. IMM-6-415 is an oral, twice-daily deep cyclic inhibitor and will be evaluated in a Phase 1/2a study in patients with advanced solid tumors harboring RAS or RAF mutations. The company’s development pipeline also includes several early-stage programs. For more information, please visit www.immuneering.com.

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FDA Fast Track for Immuneering’s Pancreatic Cancer Candidate

Catie Corcoran

Biotech Editor