First Patient Treated in Phase 2a Trial of IMM-1-104 for RAS-mutant Tumors

Immuneering Corporation has commenced the Phase 2a segment of its Phase 1/2a clinical trial for IMM-1-104, marking a significant step in the company's pursuit to create universal-RAS/RAF medications for a wide range of cancer patients. The first patient has been administered IMM-1-104 in conjunction with modified gemcitabine and nab-paclitaxel as a primary treatment for pancreatic ductal adenocarcinoma (PDAC). The Phase 2a trial, which is anticipated to involve around 150 participants, will assess the efficacy of IMM-1-104 as a standalone treatment for PDAC, non-small cell lung cancer (NSCLC), and melanoma, as well as in combination with other therapies for PDAC. The company, led by CEO Ben Zeskind, is optimistic about the drug's potential based on preclinical data and the significant need for new treatment options in these areas. The Phase 1 data is expected to be released in March 2024, with preliminary results from the Phase 2a trial expected later that year.

The Phase 2a trial's design includes five distinct arms, each focusing on different cancer types and treatment lines, with 30 patients per arm. The arms are as follows:

·PDAC patients in the first or second line of treatment.
·Melanoma patients with RAS mutations after immunotherapy or as a first-line option for those ineligible for current treatments.
·NSCLC patients with RAS mutations in the second or third line of treatment.
·PDAC patients receiving mFOLFIRINOX in the first line of treatment.
·PDAC patients in the first line of treatment with a combination of modified gemcitabine and nab-paclitaxel.

Immuneering is dedicated to developing a universal-RAS therapy through the deep cyclic inhibition of the MAPK pathway, targeting cancer cells while preserving healthy ones. Their lead candidate, IMM-1-104, is an oral medication undergoing Phase 1/2a trials for advanced solid tumors with RAS mutations. Another candidate, IMM-6-415, will be evaluated in similar trials for RAS or RAF mutation-carrying tumors. 

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