Immuneering Completes Dose Escalation in the IMM-1-104 Phase 1 Clinical Trial for RAS-Mutant, Advanced Solid Tumors

- No dose limiting toxicities observed with IMM-1-104 up to 320 mg once daily during the Phase 1a dose escalation portion of ongoing clinical study -

- Phase 1b dose expansion has commenced; plan to enroll 21 additional patients at 240 mg or 320 mg daily -

- Recommended Phase 2 dose (RP2D) and additional safety data expected in early 2024 -

- Additional trial updates expected on a periodic basis -

CAMBRIDGE, Mass., June 05, 2023 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company developing medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy, today announced the completion of the dose-escalation portion of the Phase 1/2a study for its lead asset IMM-1-104 in patients with advanced solid tumors. The study’s Safety Review Committee (SRC) completed its evaluation and determined that doses up to and including 320 mg once daily are tolerable with no dose limiting toxicities. Enrollment in the Phase 1b expansion portion of the study will now commence and is designed to evaluate two dosing cohorts of 12 patients each at an oral dose of 240mg or 320 mg once daily. Three patients already enrolled in the study have been dosed at the 320 mg dose level.

“We are very pleased to have completed the dose escalation portion of our Phase 1 study of IMM-1-104 ahead of our original timeline,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “We believe the two dose levels we have chosen for our Phase 1b dose expansion study will effectively support the conditions necessary for deep cyclic inhibition, Immuneering’s unique approach that aims for Universal-RAS activity: treating patients with any mutation in KRAS, NRAS, or HRAS. As such, the 21 additional patients we plan to enroll in this next part of the study should materially add to our dataset for IMM-1-104 in patients with RAS-mutant solid tumors consistent with Project Optimus. We expect to provide further trial updates on a periodic basis and to share preliminary anti-tumor activity data before we announce a recommended Phase 2 dose in early 2024.”

“We are encouraged by the levels of enthusiasm from the investigators at our five clinical sites, who are committed to screening and enrolling patients as quickly and judiciously as possible,” said Scott Barrett, M.D., Chief Medical Officer of Immuneering. “We remain grateful to our clinical investigators for their unwavering dedication to evaluating much needed options for these heavily pretreated patients, as well as to the patients and caregivers participating in our trials.”