More than half of all tumors rely on inappropriate activation of the RAS/RAF/MEK pathway, yet existing drugs targeting this pathway are limited by toxicity or are narrowly focused on subpopulations with specific mutations. Immuneering’s novel drug candidates spare healthy normal cells by modulating cell signaling dynamics to selectively impact tumor cells.
Multiple Additional Programs
Oncology – Select Therapies
IMM-1-104 aims to achieve universal-RAS activity that selectively impacts cancer cells to a greater extent than healthy cells, through deep cyclic inhibition of the MAPK pathway with once-daily dosing. IMM-1-104 is currently being evaluated in a Phase 1/2a study in patients with advanced solid tumors harboring RAS mutations. (NCT05585320)
IMM-6-415 is a deep cyclic inhibitor of the MAPK pathway designed with unique drug-like properties including a shorter half-life for an accelerated cadence that will be evaluated twice-daily in humans. In animal studies, IMM-6-415 strongly inhibited the growth of tumors with RAF or RAS mutations, as both a monotherapy and in combinations. (NCT06208124)
Expanded Access Policy
Expanded access, sometimes also referred to as “compassionate use,” is a potential alternative for patients to receive investigational treatments outside of a clinical trial. According to FDA, expanded access may be applicable when all the following apply:
- Patients have a serious or immediately life-threatening disease or condition;
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition;
- Patient enrollment in a clinical trial is not possible;
- Potential patient benefit justifies the potential risks of treatment; and
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
At this time, expanded access is not available for any of our product candidate programs. We aim to provide investigational treatments when they have the greatest potential to benefit patients. Our lead product candidates IMM-1-104 and IMM-6-415 are currently still in the early stages of development, and clinical trials are ongoing to understand, among other things, the potential safety and efficacy of these investigational treatments. We believe that participation in a clinical trial is currently the most appropriate way for a patient to receive one of our product candidates in development. Clinical trials for our programs are provided above, and here hyperlinked to clinicaltrials.gov for more information. We will periodically assess the potential appropriateness of expanded access in the future, and may revise our policy as the development of our product candidate programs progresses.
If you have additional questions regarding expanded access or participation in a clinical trial, please speak with your physician or contact firstname.lastname@example.org.