Immuneering Corporation announced positive initial data from its Phase 2a clinical trial evaluating IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel for first-line pancreatic cancer. The early results show promising response rates and disease control in a patient population with high unmet medical needs.
Encouraging Initial Response Data
The Phase 2a trial arm investigating IMM-1-104, at a 240 mg QD dose, in combination with modified gemcitabine/nab-paclitaxel, has shown complete or partial responses in the first two of five patients, resulting in an initial overall response rate (ORR) of 40%. The disease control rate (DCR) was observed to be 80%, with all five patients continuing on treatment. These initial results are being compared to benchmarks for gemcitabine/nab-paclitaxel alone, where previous studies showed a 23% ORR and a 48% DCR.
"We are delighted to share today’s initial data on IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel. While the initial ORR of 40% and Disease Control Rate of 80% are very encouraging – and both more than would be expected for gemcitabine/nab-paclitaxel alone- we are still in the early stages of this trial, with more scans for all five of these initial patients and for additional patients planned to come. Nevertheless, it was encouraging to see a complete response in the very first pancreatic cancer patient treated with IMM-1-104 in this combination, with the patient now on treatment for over six months," said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering.
Safety and Tolerability
The combination of IMM-1-104 plus modified gemcitabine/nab-paclitaxel has been observed to be well-tolerated, with a safety profile consistent with the known data for both therapeutics. Based on these safety data, the trial's Data and Safety Monitoring Board (DSMB) has approved enrolling additional patients at a higher dose of 320mg QD p.o.
IMM-1-104: A Potential Universal-RAS Therapy
IMM-1-104 is designed to achieve universal-RAS activity, selectively impacting cancer cells through Deep Cyclic Inhibition of the MAPK pathway with once-daily dosing. The drug is currently being evaluated in a Phase 1/2a study in patients with advanced solid tumors harboring RAS mutations.
Future Development
Immuneering anticipates a clear path forward for the clinical development of IMM-1-104 in combination with gemcitabine/nab-paclitaxel for pancreatic cancer, assuming the initial data proves representative. The FDA has previously granted IMM-1-104 Fast Track designation for the treatment of first- and second-line pancreatic ductal adenocarcinoma. Further data from the Phase 2a trial is expected by year-end.
"These exciting early clinical findings are consistent with the preclinical data we shared at AACR earlier this year, which pointed to synergies between IMM-1-104 and chemotherapeutics - driving deeper more durable responses than either can achieve alone," said Brett Hall, Ph.D., Chief Scientific Officer, Immuneering Corporation.
