– Updated data for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients show favorable overall response rate (ORR = 43%) and disease control rate (DCR = 86%); planning for pivotal trial underway –
– Favorable initial data for IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer patients show target lesion shrinkage in all evaluable patients, including a 100% reduction (PR) –
– Encouraging initial data for IMM-1-104 monotherapy in second-line pancreatic cancer, including a 67% reduction (PR), demonstrate activity and support development in first-line combinations; over 75 patients enrolled across all three Phase 2a pancreatic arms –
– Continued highly differentiated tolerability profile observed for IMM-1-104;
approved MEK inhibitors currently drive ~$2.4 billion in sales –
– Further IMM-1-104 Phase 2a data expected in 2Q’25; additional combination arms planned to be initiated in 2025 –
– Company to hold webcast today at 8.30 am ET /5:30 am PT –
CAMBRIDGE, Mass., Jan. 07, 2025 — Immuneering Corporation (NASDAQ: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, today announced a positive data update from three pancreatic cancer arms of its ongoing Phase 2a trial of lead program IMM-1-104, as well as plans to expand the Phase 2a trial to include three additional combination arms. While approved MEK inhibitors mainly benefit a subset of patients with BRAF-driven tumors, IMM-1-104 was designed to improve tolerability and expand indications to include RAS-mutated tumors such as those found in most pancreatic cancers.
“We are excited to report an updated ORR of 43% and DCR of 86% for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients. For reference, the benchmark reported for gemcitabine/nab-paclitaxel in this setting had an ORR of 23% and DCR of 48%. We look forward to reporting further data in the second quarter of 2025 and have started planning for a potential pivotal clinical trial,” said Ben Zeskind, Ph.D., CEO of Immuneering.
Dr. Zeskind continued: “Today we are also sharing initial data from IMM-1-104 in combination with modified FOLFIRINOX in first-line pancreatic cancer patients. We observed target lesion shrinkage across all evaluable patients, including a 100% reduction, a rare event in this patient population. Additionally, we are reporting initial data from our monotherapy arm of IMM-1-104 in second-line pancreatic cancer. We saw clear activity, including a partial response with a 67% target lesion reduction. We believe these results provide substantiating evidence of IMM-1-104’s contribution in combination with current therapies.”
Dr. Zeskind concluded: “Importantly, we continue to observe a highly differentiated safety profile for IMM-1-104, which we designed to be better tolerated and more active than existing approved MEK inhibitors already driving annual net sales of ~$2.4 billion in 2023. Accordingly, we plan to add three new Phase 2a combination arms: IMM-1-104 with a BRAF inhibitor in BRAF-mutant melanoma, and IMM-1-104 with an immune checkpoint inhibitor in both melanoma and NSCLC. We expect to initiate these arms in 2025. Today we are setting a path to break new ground in indications where no MEK inhibitors have been approved, including pancreatic cancer, and aim to provide a better tolerated and more effective alternative where MEK inhibitors are already helping patients.”
Updated Data from Phase 2a Arm Evaluating IMM-1-104 with Modified Gemcitabine/nab-Paclitaxel in First Line Pancreatic Cancer as of December 5, 2024
Source: Immuneering Corporation
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As of December 5, 2024, three patients in the Phase 2a arm evaluating IMM-1-104 with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer achieved complete or partial responses for an overall response rate of 43% (3/7) and disease control rate of 86% (6/7). Four patients remain on treatment.
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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 (CR) out of 431 patients, a 23% Overall Response Rate, and a 48% Disease Control Rate1. Benchmarks for modified (m) Gemcitabine/nab-Paclitaxel, the less intensive regimen utilized in the IMM-1-104 Phase 2 combination arm, include an 18.6% ORR2.
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A favorable tolerability profile was observed for IMM-1-104 in combination with modified Gemcitabine/nab-Paclitaxel.
[1] Von Hoff, et al. N Engl J Med 2013;369:1691-1703, [2] Ahn DH, et al. Therapeutic Advances in Medical Oncology. 2017;9(2):75-82
“Immuneering’s Phase 2a data in first-line pancreatic cancer are very promising,” said Tanios Bekaii-Saab, M.D., Leader of the Gastrointestinal Cancer Disease Group for the Mayo Clinic Cancer Center enterprise-wide and Medical Oncology consultant in Mayo Clinic in Phoenix, Arizona. “If current trends continue, the combination of IMM-1-104 with modified gemcitabine/nab-paclitaxel may provide improved efficacy and tolerability versus gemcitabine/nab-paclitaxel in the first-line pancreatic cancer setting, where patients continue to urgently need better options. In addition, having a MEK inhibitor that appears to be as well-tolerated as IMM-1-104 may provide new opportunities for patients with different types of cancer.”
Initial Data from Phase 2a Arm Evaluating IMM-1-104 with Modified FOLFIRINOX in First Line Pancreatic Cancer as of December 5, 2024
Source: Immuneering Corporation
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As of December 5, 2024, all evaluable patients (n=4) experienced target tumor shrinkage and disease control, with one patient achieving a 100% reduction (PR).
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The combination of IMM-1-104 plus modified FOLFIRINOX (mFFX) was observed to be generally well tolerated.
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The Company is currently evaluating the 320 mg QD dose of IMM-1-104 in combination with modified FOLFIRINOX.
Initial Data from Phase 2a Arm Evaluating IMM-1-104 Monotherapy in Second Line Pancreatic Cancer as of December 5, 2024
Source: Immuneering Corporation
“Having demonstrated compelling activity in both the combination and monotherapy settings for pancreatic cancer, the emerging tolerability profile for IMM-1-104 is also highly promising,” said Brett Hall, Ph.D., Chief Scientific Officer, Immuneering Corporation. “Looking at the table of treatment-related adverse events observed in greater than 10% of patients in our monotherapy arm, no Grade 3 or Grade 4 events were observed, and only a handful of Grade 2 events were observed. The maturing safety profile for IMM-1-104 gives us confidence that Immuneering may have developed a better tolerated MEK-inhibitor, with exciting potential for vertical, immune-modifying, and orthogonal combinations. We expect to share expanded development plans for IMM-1-104 beyond pancreatic cancer, as we continue to explore options with investigators and third parties.”
Source: Immuneering Corporation
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As of December 5, 2024, eleven of the twenty-one evaluable patients treated in the Phase 2a arm assessing IMM-1-104 as monotherapy in second-line pancreatic cancer achieved disease control, including one patient with 67% target lesion shrinkage (PR). Nine patients remain on treatment.
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IMM-1-104 monotherapy was observed to be very well tolerated in second-line pancreatic cancer patients, suggesting that IMM-1-104 may be highly suitable for both monotherapy and combination therapy.
Immuneering previously announced that IMM-1-104 received Fast Track designation from the FDA for the treatment of first- and second-line pancreatic cancer, along with orphan drug designation. The FDA also recently granted Fast Track designation for IMM-1-104 as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors. Today’s data update follows initial data that was presented in September 2024 on the trial’s arm studying IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer.
Today, Immuneering also announced initial pharmacokinetic, pharmacodynamic and safety data from the Phase 1 portion of the company’s Phase 1/2a trial of IMM-6-415. To date, IMM-6-415 has demonstrated its potential to induce Deep Cyclic Inhibition, and in doing so has been well tolerated – consistent with what was observed preclinically for the development candidate.
Near-Term Milestone Expectations
IMM-1-104
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Further IMM-1-104 Phase 2a data expected in the second quarter of 2025
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Initiation of Phase 2a arm of IMM-1-104 in combination with BRAF inhibitor in melanoma planned for 2025
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Initiation of Phase 2a arms of IMM-1-104 in combination with checkpoint inhibitors in both melanoma and NSCLC planned for 2025
Conference Call
Immuneering will host a conference call and live webcast at 8:30 a.m. ET / 5:30 a.m. PT on January 7, 2025, to discuss the data and provide a business update. Individuals interested in listening to the live conference call may do so by dialing (800) 715-9871 for U.S callers and (646) 307-1963 for other locations and reference conference ID 4497245, or from the webcast link in the “investors” section of the company’s website at www.immuneering.com A webcast replay will be available in the investor relations section on the company’s website for 90 days following the completion of the call.
About Immuneering Corporation
Immuneering is a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients. The Company’s lead product candidate, IMM-1-104, is an oral, once-daily deep cyclic inhibitor of MEK designed to improve tolerability and expand indications to include RAS-driven tumors such as most pancreatic cancers. IMM-1-104 is currently in a Phase 1/2a trial in patients with advanced solid tumors including pancreatic cancer. IMM-6-415 is an oral, twice-daily deep cyclic inhibitor of MEK currently in a Phase 1/2a trial in patients with advanced solid tumors harboring RAS or RAF mutations. The company’s development pipeline also includes several early-stage programs. For more information, please visit www.immuneering.com.