IMM-1-104 found to be well tolerated with no dose limiting toxicities or serious adverse events

Immuneering – a company developing medicines for cancer patients – has announced positive pharmacodynamic (PD) and pharmacokinetic (PK) safety data from its phase 1 trial.

The study concerns its candidate therapy, IMM-1-104, which has also been presented at the American Association for Cancer Research (AACR) annual meeting.

The phase 1/2a research is an open-label study which aims to establish the tolerability, safety, PK and preliminary efficacy of the IMM-1-104 candidate among patients with advanced RAS mutant solid tumours.

The phase 1 element, which is unfolding at five clinical sites, is evaluating the treatment following a pivotal escalation design. This includes a phase to determine dose escalation and evaluation.

IMM-1-104 was found to be well tolerated with no dose limiting toxicities or serious adverse events. Meanwhile, the first demonstration of novel deep cyclic inhibition mechanism in humans using IMM-1-104 achieved significant levels of PK Cmax (the concentration of drug present after administration).

The data also revealed the potential to evaluate preliminary efficacy sooner than expected.

Following this research, Immuneering will conduct a phase 2a dose expansion phase to assess efficacy and further safety aspects relating to IMM-1-104 when used to treat mutated pancreatic, melanoma, lung and colorectal cancers.

Brett Hall, chief scientific officer at Immuneering, was optimistic about the emerging results: “This initial PK and PD phase 1 data with IMM-1-104 marks a major milestone for Immuneering, and for patients affected by RAS mutant tumours. It is the first time IMM-1-104 has shown the profile we believe is necessary for deep cyclic inhibition in humans.”

Ben Zeskind, chief executive officer at Immuneering, added: “We are very pleased to share initial PK, PD and safety data from our phase 1 trial of IMM-1-104 in patients with advanced RAS mutant solid tumors, ahead of schedule.

“These results position us to accelerate the dose escalation portion of our study, reaching potentially therapeutic levels of IMM-1-104 earlier than previously planned.”

Scott Barrett, chief medical officer at Immuneering, concluded: “We are grateful to the patients participating in our trial, and to the investigators. Investigator enthusiasm remains high, which combined with our study’s broad inclusion criteria, gives us confidence in our ability to keep enrolling patients.”