Immuneering Doses First Patient in Phase 2a Clinical Trial of IMM-1-104 in RAS-mutant Solid Tumors
Immuneering Corporation recently announced 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, PhD, 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).
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, visit www.immuneering.com.
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