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Immuneering Announces Positive Initial Phase 2a Data Including Complete and Partial Responses with IMM-1-104 in Combination with Chemotherapy in First-Line Pancreatic Cancer Patients

– In Phase 2a arm investigating IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel, complete or partial responses have been observed in the first two patients (2/5) to date, for an initial response rate of 40% and an initial disease control rate of 80%, with all five patients continuing on treatment –

– Initial data are at 240 mg QD (safety lead-in dose) of IMM-1-104; additional patients have now been dosed at 320 mg QD in this arm; IMM-1-104 has been well-tolerated to date in combination with gemcitabine/nab-paclitaxel –

– Initial data are consistent with preclinical data presented at AACR, which demonstrated that IMM-1-104 combined with chemotherapy induced deeper responses than either agent alone –

– Clear path forward expected for clinical development of IMM-1-104 in combination with gemcitabine/nab-paclitaxel for pancreatic cancer, assuming initial data is representative; FDA previously granted IMM-1-104 Fast Track designation for the treatment of first- and second-line pancreatic ductal adenocarcinoma –

Enrollment progressing in all Phase 2a arms with further data expected by year end –

Excerpt from the Press Release:

CAMBRIDGE, Mass., Sept. 12, 2024 (GLOBE NEWSWIRE) — Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced positive 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.

“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. “Looking at the bigger picture, our Phase 2a trial aims to evaluate the efficacy of IMM-1-104 in multiple settings across various tumor types, to identify the highest priority opportunities for future development. If the early trends with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel continue, we will have an exciting direction for potential future development of IMM-1-104, which could greatly improve the prognosis for a drastically underserved patient population.”

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