On January 13, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, reported a positive update from its Phase 2a arm studying IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer, and provided a corporate update (Press release, Immuneering, JAN 13, 2025, View Source [SID1234649661]).

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"We are thrilled to report two more responses in our Phase 2a arm studying IMM-1-104 in combination with modified FOLFIRINOX in first-line pancreatic cancer," said Ben Zeskind, Ph.D., CEO of Immuneering. "The response rates emerging from both of our Phase 2a combination arms in first-line pancreatic cancer are comparable to one another, and speak not only to IMM-1-104’s potential to drive a new standard of care in pancreatic cancer, but also its potential as a first-of-its-kind, well-tolerated MEK inhibitor that could be safely used in a variety of combinations to drive better outcomes for patients across a range of indications."

Zeskind continued: "Building on our positive January 7, 2025 data update, we strengthened our cash balance with nearly $14 million in net proceeds raised through our ATM facility. We began 2025 strong and intend to sustain that momentum throughout the year, including with a planned second quarter 2025 Phase 2a trial data update, the anticipated initiation of new combination trial arms, and planning for a pivotal trial of IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel."

Since the Company’s prior update on January 7, 2025 (which used a data cutoff date of December 5, 2024), two new partial responses (PRs) have been reported.
As of January 6, 2025, there were six evaluable patients in the Phase 2a arm evaluating IMM-1-104 with modified FOLFIRINOX in first-line pancreatic cancer; three patients achieved partial responses (one unconfirmed) for an overall response rate of 50% (3/6). Four patients remain on treatment. The historic benchmark ORR is 32% for FOLFIRINOX alone.
The combination of IMM-1-104 plus modified FOLFIRINOX (mFFX) was observed to be generally well tolerated.
The Company is currently evaluating the 320 mg QD dose of IMM-1-104 in combination with modified FOLFIRINOX.
Additionally, Immuneering reported that it raised net proceeds of $13.7 million through utilization of its ATM facility following its January 7, 2025 update from its ongoing Phase 2a clinical trial.

Near-Term Milestone Expectations

IMM-1-104

Further IMM-1-104 Phase 2a data expected in the second quarter of 2025
Initiation of Phase 2a arms of IMM-1-104 in combination with a BRAF inhibitor, as well as IMM-1-104 in combination with a checkpoint inhibitor, planned for 2025