Immuneering Doses First Patient in Phase 2a Clinical Trial of IMM-1-104 in RAS-mutant Solid Tumors

- First patient dosed with IMM-1-104 in combination with modified gemcitabine plus nab-paclitaxel for first-line treatment of pancreatic ductal adenocarcinoma (PDAC) -

- Phase 2a portion of Phase 1/2a clinical trial will evaluate IMM-1-104 as monotherapy in PDAC, non-small cell lung cancer (NSCLC) and melanoma, and as combination therapy in PDAC -

- Topline data from the Phase 1 portion of Phase 1/2a trial of IMM-1-104 expected in March 2024 -

- Initial data from multiple Phase 2a arms expected in 2024 -

CAMBRIDGE, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced that the first patient has been dosed in the Phase 2a portion of its Phase 1/2a clinical trial of IMM-1-104, its lead program. IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of MEK in the MAPK pathway with once-daily oral dosing.

“The initiation of our Phase 2a study is an important milestone for Immuneering, as we evaluate IMM-1-104 in larger numbers of patients with specific types of cancer, at earlier stages of disease, with a broader set of endpoints, and a growing team of both investigators and study sites,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “The Phase 2a portion includes both monotherapy and combination arms, all in tumor types where we believe IMM-1-104 has the greatest potential to make a positive impact. We are excited to be evaluating IMM-1-104 as a combination therapy for the first time in the clinic, with an initial focus on PDAC in the first-line setting based on compelling, previously generated preclinical data, well-understood disease biology, and a vast unmet medical need. We look forward to sharing our topline Phase 1 data this month, and then reporting initial results from multiple arms of our Phase 2a later in 2024, which is shaping up to be a data-rich year for our company.”

The Phase 2a portion of the Phase 1/2a clinical trial of IMM-1-104 is expected to include approximately 150 patients in five arms at our recommended Phase 2 dose of 320 mg once daily. The five arms are as follows:

• IMM-1-104 monotherapy in patients with pancreatic ductal adenocarcinoma (PDAC) in the first- or second-line setting (n=30).
• IMM-1-104 monotherapy in patients with RAS-mutant melanoma in the second- or third-line setting post-immunotherapy, or in the first-line setting for patients who are not candidates for existing therapies (n=30).
• IMM-1-104 monotherapy in patients with RAS-mutant non-small cell lung cancer (NSCLC) in the second- or third-line setting (n=30).
• IMM-1-104 in combination with mFOLFIRINOX in patients with PDAC in the first-line setting (n=30).
• IMM-1-104 in combination with modified gemcitabine plus nab-paclitaxel in patients with PDAC in the first-line setting (n=30).