Immuneering Shares Climb After Pursuing FDA Nod For RAS Mutant Tumor Study

Immuneering Shares Climb After Pursuing FDA Nod For RAS Mutant Tumor Study

Immuneering IMRX submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its product candidate IMM-1-104 in development for the treatment of advanced RAS mutant solid tumors.

The company is planning to evaluate IMM-1-104 in a Phase 1/2a clinical trial for the treatment of advanced solid tumors with RAS mutations.

Ben Zeskind, Chief Executive Officer, said, "At Immuneering we aim to create medicines for all patients with tumors driven by RAS mutations and other challenging MAPK pathway activation events. In our animal studies, IMM-1-104 strongly inhibited the growth of some of the most aggressive and deadly RAS mutant tumor models out there, without the need to combine with other agents and with good preclinical tolerability. Filing the IND brings us one step closer to evaluating IMM-1-104 in patients with a broad range of RAS mutant tumors.”

The regulatory agency will review the IND application and determine whether the data package is acceptable to predict the safety of IMM-1-104, before clinical trial initiation.

Immuneering anticipates to initiate patient enrolment in the fourth quarter and planning to sponsor the recruitment of patients at five internationally recognized clinical sites in the United States.

Price Action : Immuneering shares are trading around 8 percent higher at $7.49 on Friday during pre-market session.

Posted In: IND FilingBiotechHealth CareGeneral