Immuneering announces initial response data from first five IMM-1-104 patients

Immuneering announced initial response data from the first five patients treated with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first line pancreatic cancer as part of its ongoing Phase 2a clinical trial. To date, the first two patients in the Phase 2a arm evaluating IMM-1-104 with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer have recorded complete or partial responses for an initial response rate of 40% and disease control rate of 80%, with the other three patients earlier in the course of treatment and all five continuing on treatment. Benchmarks for gemcitabine/nab-paclitaxel alone in first-line pancreatic cancer patients were established by the Phase 3 MPACT study, which included 1 Complete Response, or CR, out of 431 patients, a 23% Overall Response Rate, and a 48% Disease Control Rate. Benchmarks for modified Gemcitabine/nab-Paclitaxel include an 18.6% ORR. To date, the combination of IMM-1-104 plus modified gemcitabine/nab-paclitaxel was observed to be well tolerated, with an emerging safety profile in line with known data for both therapeutics respectively. Based on safety data to date, the trial’s Data and Safety Monitoring Board, or DSMB. has approved enrolling additional patients into this arm at 320mg QD p.o., the first of which have already been dosed and are awaiting first scans. Initial IMM-1-104 data from at least one additional arm of the Phase 2a portion of the company’s Phase 1/2a trial is expected by year end. Initial IMM-6-415 pharmacokinetic, or PK, pharmacodynamic, or PD, and safety data from the Phase 1 portion of the company’s Phase 1/2a trial is expected by year end.