atebimetinib (IMM-1-104) / Immuneering - LARVOL DELTA

Atebimetinib's deep cyclic inhibition of MEK constrains MAPK-axis adaptive and acquired alterations in patients with RAS-mutant tumors (AACR 2026) - "Atebimetinib-treated patient data demonstrate that deep, pulsatile MEK inhibition prevents the sustained loss of adaptive feedback commonly observed with chronic MAPK-pathway blockade, thereby reducing selective pressure for MAPK-reactivating resistance mechanisms. The resulting shift toward non-MAPK pathways suggests that atebimetinib's DCI mechanism, unlike chronic target engagement, limits MAPK-axis evolution. The low incidence of RAS/MAPK reactivation events supports evaluation of atebimetinib as a preferential combination backbone with either mutant-selective RAS inhibitors or mechanistically complementary therapies to enhance response durability and constrain RAS/MAPK pathway-mediated escape."

Clinical • Oncology • Solid Tumor • KRAS

Immuneering to Present Molecular Data at 2026 AACR Annual Meeting from Atebimetinib-Treated Patients, Highlighting Mechanism Designed to Improve Durability and Survival (GlobeNewswire)

Clinical data • Oncology

Near-Term Milestone Expectations (GlobeNewswire) - "(i) Q2 2026: Report updated circulating tumor DNA data on acquired alterations at a major scientific meeting; (ii) 1H 2026: Report updated survival data from over 50 first-line pancreatic cancer patients treated with atebimetinib + mGnP; (iii) Mid-2026: Dose first patient in pivotal Phase 3 clinical trial of atebimetinib in combination with mGnP in first-line pancreatic cancer; (iv) 2H 2026: Dose first patient in trial of atebimetinib in combination with Libtayo in non-small cell lung cancer."

Biomarker • New trial • P2a data • Non Small Cell Lung Cancer • Pancreatic Adenocarcinoma

Immuneering…announced positive updated overall survival (OS) and safety data from its ongoing Phase 2a trial of atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N=34), with over 13 months median follow up time (GlobeNewswire) - "64% OS observed at 12 months; standard of care benchmark reported a 35% OS at 12 months. 83% OS observed at 9 months; standard of care benchmark reported a ~47% OS at 9 months. 94% OS observed at 6 months; standard of care benchmark reported a 67% OS at 6 months....Confirmed Overall Response Rate (ORR) of 39% at 12 months; standard of care benchmark reported an ORR of 23%. Disease Control Rate (DCR) of 81% at 12 months; standard of care benchmark reported a DCR of 48%. Median Progression Free Survival (mPFS) of 8.5 months; standard of care benchmark reported a mPFS of 5.5 months."

P2a data • Pancreatic Adenocarcinoma

Immuneering to Announce 12-Month Overall Survival Data from Phase 2a Clinical Trial of Atebimetinib + mGnP in First-Line Pancreatic Cancer Patients on January 7, 2026 (GlobeNewswire)

P2a data • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Immuneering Advances Towards Dosing First Patient in Phase 3 Atebimetinib Trial for First-Line Metastatic Pancreatic Cancer Patients, Securing Alignment with FDA and EMA (GlobeNewswire) - "End-of-Phase 2 interactions with FDA complete; scientific advice received from EMA. Company expects to dose first patient in global Phase 3 registrational trial, MAPKeeper 301, in mid-2026. Overall survival update for Phase 2a trial of atebimetinib + mGnP in first-line pancreatic cancer patients planned in coming weeks....MAPKeeper 301 is designed as a global Phase 3 trial that will evaluate atebimetinib (320 mg QD) in combination with mGnP, compared to standard of care GnP alone, in first-line metastatic pancreatic ductal adenocarcinoma....The company expects to...share topline results from the trial in mid-2028."

New P3 trial • P2a data • Regulatory • Pancreatic Ductal Adenocarcinoma

IMM1104-101: A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=209 | Active, not recruiting | Sponsor: Immuneering Corporation | Recruiting ➔ Active, not recruiting | N=320 ➔ 209

Enrollment change • Enrollment closed • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • APC • HRAS • KRAS

Near-Term Milestone Expectations (GlobeNewswire) - "Immuneering is planning for several near-term anticipated milestones related to atebimetinib, including: (i) Regulatory feedback on pivotal trial plans in Q4 2025; (ii) Announcing further updated OS and PFS data from first-line pancreatic cancer patients (N=34) treated with atebimetinib + mGnP, including at a scientific conference in 2026; (iii) Pending regulatory feedback, initiating a pivotal Phase 3 trial of atebimetinib in combination with mGnP in first-line pancreatic cancer by the end of 2025, and dosing the first patient by mid-2026; (iv) Initiating additional atebimetinib clinical trial combination arms in 2026, including in non-small cell lung cancer."

Clinical protocol • FDA event • New P3 trial • P2a data • Non Small Cell Lung Cancer • Pancreatic Cancer

Immuneering Corporation…announced positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N=34), with 9 months median follow up (GlobeNewswire) - "The data, to be presented at the Pancreatic Cancer Action Network (PanCAN) Scientific Summit 2025....86% overall survival (OS) observed at 9 months; standard of care benchmark is ~47%. 53% progression-free survival (PFS) observed at 9 months; standard of care benchmark is ~29%."

P2a data • Pancreatic Cancer

Immuneering to Announce Updated Overall Survival Data from Phase 2a Clinical Trial of Atebimetinib + mGnP in First-Line Pancreatic Cancer Patients on September 25 (GlobeNewswire) - "Immuneering plans to then share the updated data at the PanCAN Scientific Summit on September 28. Additionally, the Company will present a review of preclinical data on Deep Cyclic Inhibitors at the 7th RAS-Targeted Drug Development Summit."

P2a data • Preclinical • Pancreatic Adenocarcinoma • Pancreatic Cancer

Immuneering Announces $25 Million Private Placement (GlobeNewswire) - "The closing of the private placement is subject to customary closing conditions and is expected to occur on or about August 26, 2025....The proceeds from this financing will help support our ongoing efforts to bring atebimetinib, our Deep Cyclic Inhibitor of MEK in the MAPK pathway, to as many cancer patients as possible as quickly as possible."

Financing • Pancreatic Cancer

Immuneering Announces Clinical Supply Agreement with Lilly to Evaluate Atebimetinib in Combination with Olomorasib (GlobeNewswire) - "The supply agreement supports the evaluation of Immuneering’s lead product candidate, atebimetinib (IMM-1-104), a novel dual MEK inhibitor, in combination with olomorasib in a planned Phase 2 clinical trial in patients with locally advanced or metastatic KRAS G12c-mutant non-small cell lung cancer (NSCLC) who have progressed on prior therapy....Immuneering will maintain global development and commercialization rights to atebimetinib."

Commercial • New P2 trial • Non Small Cell Lung Cancer

Immuneering Granted U.S. Composition of Matter Patent for Highly Differentiated Cancer Drug Candidate Atebimetinib (GlobeNewswire) - "Immuneering...announced that the United States Patent and Trademark Office (USPTO) granted the company a composition of matter patent for atebimetinib (IMM-1-104), an oral once-daily deep cyclic inhibitor of MEK. MEK is a key component of the signaling pathway that drives the majority of cancers, including pancreatic cancer....U.S. Patent No. 12,351,566, titled: 'MEK Inhibitors and Therapeutic Uses Thereof', includes claims to atebimetinib’s composition of matter. The patent’s term, which includes a patent term adjustment, is currently expected to expire in August 2042. The patent may also be eligible for patent term extension to recover a portion of the time required to fulfill regulatory approval requirements....Additional patent applications pending for atebimetinib directed to compounds, pharmaceutical compositions, and methods of use with expiration expected into 2044."

Patent • Pancreatic Cancer

Near-Term Milestone Expectations (GlobeNewswire) - "...Immuneering is planning for several additional milestones related to atebimetinib, including: Regulatory feedback on pivotal study plans in 4Q 2025; Data from additional patients in Phase 2a trial in 4Q 2025; Initiation of pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026; Initiation of additional atebimetinib clinical trial combination arms in 2026."

New trial • P2a data • Regulatory • Trial status • Pancreatic Ductal Adenocarcinoma

Immuneering Reports Positive Overall Survival Data for Atebimetinib (IMM-1-104) from Ongoing Phase 2a Trial in First-Line Pancreatic Cancer Patients (GlobeNewswire) - P1/2a | N=320 | NCT05585320 | Sponsor: Immuneering Corporation | "94% overall survival (OS) was observed at 6 months in first-line (1L) pancreatic cancer patients treated with atebimetinib + mGnP at the 320 mg once-daily dose of atebimetinib (N=34). The benchmark 6-month OS for the standard of care treatment in this population (full dose and schedule GnP) is 67%.1 The median OS was not yet reached at the data cutoff date. 72% progression-free survival (PFS) was observed at 6 months in first-line (1L) pancreatic cancer patients treated with atebimetinib + mGnP at the 320 mg dose level (N=34). The benchmark 6-month PFS for the standard of care treatment in this population (full dose and schedule GnP) is 44%. The median PFS was not yet reached at the data cutoff date."

P2a data • Pancreatic Ductal Adenocarcinoma

Immuneering to Provide Updates from Phase 2a Clinical Trial of IMM-1-104 in First-Line Pancreatic Cancer Patients on Tuesday, June 17, 2025 (GlobeNewswire) - "Immuneering Corporation...announced that it will host a conference call and live webcast at 8:00 am ET on June 17, 2025. The company is excited to provide updates from its ongoing Phase 2a clinical trial of IMM-1-104 in first-line pancreatic cancer patients."

P2a data • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Immuneering Reports First Quarter 2025 Financial Results and Provides Business Updates (GlobeNewswire) - "Near-Term Milestone Expectations: IMM-1-104: (i) Initial progression-free survival data from the IMM-1-104 Phase 2a trial expected in the second quarter of 2025; (ii) Additional IMM-1-104 combination arms in planning; (iii) Initiation of Phase 3 trial of IMM-1-104+mGnP in first-line pancreatic cancer planned for 2026."

New P3 trial • P2a data • Trial status • Cutaneous Melanoma • Non Small Cell Lung Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer

IMM1104-101: A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: Immuneering Corporation | N=210 ➔ 320

Enrollment change • Colorectal Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • APC • HRAS • KRAS

Immuneering Announces Clinical Supply Agreement with Regeneron Pharmaceuticals to Evaluate IMM-1-104 in Combination with Libtayo (cemiplimab) (GlobeNewswire) - "Immuneering Corporation...today announced a clinical supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo (cemiplimab). The supply agreement supports the evaluation of Immuneering’s lead product candidate, IMM-1-104, in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer (NSCLC) in Immuneering’s ongoing Phase 2a clinical trial of IMM-1-104 in advanced solid tumors."

Commercial • Non Small Cell Lung Cancer

Immuneering Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "Near-Term Milestone Expectations: IMM-1-104: (i) Further IMM-1-104 Phase 2a data expected in the second quarter of 2025; (ii) Initiation of Phase 2a arm of IMM-1-104 in combination with Libtayo in NSCLC planned for 2025; (iii) Initiation of Phase 2a arm of IMM-1-104 in combination with a G12C inhibitor in NSCLC planned for 2025; (iv) Initiation of Phase 2a arm of IMM-1-104 in combination with a PD-1 inhibitor in melanoma planned for 2025; (v) Initiation of Phase 2a arm of IMM-1-104 in combination with a BRAF inhibitor in melanoma planned for 2025."

New P2a trial • P2a data • Melanoma • Non Small Cell Lung Cancer • Pancreatic Adenocarcinoma

IMM-1-104 Treatment May Improve Responses in Pancreatic Cancer (Cure Today) - "'Immuneering's phase 2a data in first-line pancreatic cancer are very promising,' Dr. Tanios Bekaii-Saab said in the release. 'If current trends continue, the combination of IMM-1-104 with modified [Gemzar plus Abraxane] may provide improved efficacy and tolerability versus [Gemzar plus Abraxane alone] 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.'"

Audio • P2a data

Immuneering Announces Positive Data Update from Three Pancreatic Cancer Arms of Ongoing Phase 2a Trial of IMM-1-104; Plans to Expand Trial with Additional Arms (GlobeNewswire) - "'Immuneering's Phase 2a data in first-line pancreatic cancer are very promising,' said Tanios Bekaii-Saab, M.D...'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.'"

Media quote

Immuneering Provides Positive Update on Phase 2a Arm Studying IMM-1-104 in Combination with Modified FOLFIRINOX for First-Line Pancreatic Cancer (GlobeNewswire) - P1/2a | N=210 | NCT05585320 | Sponsor: Immuneering Corporation | "Since the Company’s prior update on January 7, 2025 (which used a data cutoff date of December 5, 2024), two new partial responses (PRs) have been reported; As of January 6, 2025, there were six evaluable patients in the Phase 2a arm evaluating IMM-1-104 with modified FOLFIRINOX in first-line pancreatic cancer; three patients achieved partial responses (one unconfirmed) for an overall response rate of 50% (3/6). Four patients remain on treatment. The historic benchmark ORR is 32% for FOLFIRINOX alone; The combination of IMM-1-104 plus modified FOLFIRINOX (mFFX) was observed to be generally well tolerated...Near-Term Milestone Expectations....Further IMM-1-104 Phase 2a data expected in the second quarter of 2025; Initiation of Phase 2a arms of IMM-1-104 in combination with a BRAF inhibitor, as well as IMM-1-104 in combination with a checkpoint inhibitor, planned for 2025."

P2a data • Trial status • Pancreatic Cancer • Solid Tumor

Immuneering Announces…Plans to Expand Trial with Additional Arms (GlobeNewswire) - "Initiation of Phase 2a arm of IMM-1-104 in combination with BRAF inhibitor in melanoma planned for 2025; Initiation of Phase 2a arms of IMM-1-104 in combination with checkpoint inhibitors in both melanoma and NSCLC planned for 2025."

Trial status • Melanoma • Non Small Cell Lung Cancer

Immuneering Announces Positive Data Update from Three Pancreatic Cancer Arms of Ongoing Phase 2a Trial of IMM-1-104; Plans to Expand Trial with Additional Arms (GlobeNewswire) - P1/2a | N=210 | NCT05585320 | Sponsor: Immuneering Corporation | "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...Further IMM-1-104 Phase 2a data expected in 2Q’25."

P2a data • Pancreatic Cancer