NEW YORK – Immuneering on Thursday said it signed a clinical supply agreement with Regeneron to obtain the anti-PD-1 therapy Libtayo (cemiplimab) for a Phase IIa trial testing Immuneering's MEK inhibitor IMM-1-104 in advanced RAS- and RAF-mutated solid tumors.
In the trial, Immuneering is evaluating IMM-1-104 as a monotherapy and in combination with approved therapies including Libtayo. Researchers are tracking safety, tolerability, and preliminary anti-tumor activity including overall response rate.
In preliminary results from the Phase I portion of the trial reported last year, among 22 patients on IMM-1-104, none acquired RAS mutations after receiving the drug, and just two patients acquired mutations in MAPK pathway genes. The early data also showed that 53 percent of patients treated with IMM-1-104 had a regression of at least one target lesion at one of the two higher dose levels.
Cambridge, Massachusetts-based Immuneering believes that combining IMM-1-104 with a PD-1 inhibitor like Libtayo will enhance anti-tumor activity while overcoming MAPK addiction in tumor cells.
Under the terms of the agreement, Immuneering will sponsor the clinical study of IMM-1-104 with Libtayo and retain global development and commercialization rights to the compound. Regeneron will supply Libtayo for the trial. The companies didn't disclose the financial terms of the agreement.