Immuneering Announces FDA Clearance of IND Application for Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors With RAF or RAS Mutations

Immuneering Corporation recently announced the US FDA has cleared its Investigational New Drug (IND) application for IMM-6-415, paving the way for the company to initiate a Phase 1/2a clinical trial of this oral, twice-daily small molecule, in development for the treatment of advanced RAF or RAS mutant solid tumors.

“The clearance of the IND application for IMM-6-415 is another important milestone in our efforts to create safer, more durable, and more effective treatment options for large groups of cancer patients,” said Ben Zeskind, Chief Executive Officer, Immuneering Corporation. “Our novel deep cyclic inhibition mechanism is designed to deprive malignant cells of the continuous high level of MAPK signaling they need to survive, while providing healthy cells with the access they need to the MAPK pathway. We believe IMM-1-104 is breaking new ground as the first deep cyclic inhibitor in the clinic, with a trial open to solid tumor patients with ANY mutation in KRAS, NRAS, or HRAS who meet the enrollment criteria. We are proud that the IMM-6-415 clinical trial will be open to an even broader group of solid tumor patients with ANY mutation in RAF, KRAS, NRAS, or HRAS who meet the enrollment criteria. We look forward to dosing the first patient in the Phase 1/2a clinical study of IMM-6-415, which is expected in early 2024.”

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.

“In the preclinical data we recently presented at AACR-NCI-EORTC, IMM-6-415 in combination with encorafenib demonstrated better tumor growth inhibition and improved durability when compared head-to-head with binimetinib plus encorafenib in animal models of RAF mutant melanoma and colorectal cancer where there is significant unmet need for new therapies,” said Brett Hall, Chief Scientific Officer, Immuneering Corporation. “Furthermore, IMM-6-415 as a single agent demonstrated high sensitivity in a wide range of MAPK-driven tumor types, including models of RAS or RAF mutant disease. Based on this promising preclinical single-agent and combination anti-tumor activity, we are excited for the opportunity to evaluate IMM-6-415 in the clinic, and hope that it will prove uniquely beneficial to many solid tumor patients.”

Immuneering is a clinical-stage oncology company seeking to develop universal-RAS/RAF medicines for broad populations of cancer patients. 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.