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

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

Immuneering Launches Pancreatic Cancer Advisory Board (GlobeNewswire) - "Immuneering Corporation...announced the formation of its Pancreatic Cancer Advisory Board. The advisory board, which comprises world-renowned oncology clinical researchers, will provide strategic medical and clinical guidance to the company as its pipeline, including lead clinical program IMM-1-104, continues to advance."

Clinical • Pancreatic Cancer

Immuneering to Present Data from Three Arms of its Ongoing Phase 2a Trial of IMM-1-104 in Early January 2025 (GlobeNewswire) - "Immuneering Corporation...announced that it will hold a virtual Investor Event in early January 2025 to discuss data from its ongoing Phase 2a trial of IMM-1-104...Specifically, the company plans to present: Additional data from IMM-1-104 in combination with mGnP in first-line pancreatic cancer; Initial data from IMM-1-104 in combination with mFFX in first-line pancreatic cancer; Initial data from IMM-1-104 monotherapy in second-line pancreatic cancer; In addition, the company will provide initial PK, PD and safety data from the Phase 1 portion of the company’s Phase 1/2a trial of IMM-6-415."

Clinical data • Pancreatic Cancer • Solid Tumor

Immuneering Granted FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma (GlobeNewswire) - "Immuneering Corporation...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead clinical-stage program, 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. IMM-1-104 is currently being evaluated in a Phase 2a clinical trial in patients with advanced solid tumors, including melanoma....'Melanoma patients are actively enrolling in one of the five arms of our Phase 2a clinical trial'..."

Evidence highlight • Fast track • Trial status • Melanoma • NRAS

Novel dual MEK inhibitors for RAS-mutated colorectal cancer as a single agent or in combination with known therapies including aPD-1 (SITC 2024) - "While the known MEK inhibitors such as Cobimetinib block the phospho-ERK (pERK) formation in BRAF-V600E mutated situation, their combination with selective BRAF inhibitors has been successfully used clinically, except colorectal cancer (CRC)...Targeted-therapy to KRAS-mutated CRC have been evaluated in clinical studies, such as KRAS-G12C inhibitors Sotorasib and Adagrasib...Methods Avutometinib and its close analogs such as IMM-1-104 and NST-628 are in clinical development...In a HCT116 xenograft model (human CRC cell-line with KRAS-G13D mutation), ABM-4095 dose-dependently inhibited tumor growth, similar to that of Avutometinib at its maximal-tolerant dose. In a CRC SW837 (KRAS-G12C, insensitive to Adagrasib) model, ABM-4218 showed synergic effect with Adagrasib, as well as the EGFR antibody Cetuximab...Conclusions In summary, A series of novel dual MEK inhibitors have been studied for the possible treatment of colorectal cancer by modulating the pERK level via the..."

Combination therapy • IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS • MAP2K1

The novel dual MEK inhibitor ABM-4095 for RAS-mutated lung cancer as a single agent or in combination with known therapies (EORTC-NCI-AACR 2024) - "While the known MEK inhibitors such as Cobimetinib block the phospho-ERK (pERK) formation in BRAF-V600E mutated situation, their combination with selective BRAF inhibitors has been successfully used clinically...Targeted-therapy to KRAS-mutated lung cancers have been extensively evaluated, resulting in the recent FDA approval of KRAS-G12C inhibitors such as Sotorasib and Adagrasib... Avutometinib and its close analogs such as IMM-1-104 and NST-628 are in clinical development...ABM-4095 showed synergic effect with erlotinib in lung cancers (KRAS-G12C H358 xenograft model)... In summary, ABM-4095 is a potent dual MEK inhibitor with activities against the RAS mutant lung cancer. ABM-4095 inhibited cell growth in vitro, and to induce tumor regression in vivo as a single agent and in combination with approved agents for the treatment of lung cancer."

Combination therapy • Lung Cancer • Oncology • Solid Tumor • KRAS

Immuneering Granted Orphan Drug Designation for IMM-1-104 by FDA in the Treatment of Pancreatic Cancer (GlobeNewswire) - "Immuneering Corporation...announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to IMM-1-104 in the treatment of pancreatic cancer. IMM-1-104 is currently being evaluated in a Phase 2a clinical trial in patients with advanced solid tumors, including pancreatic cancer...Initial 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."

Orphan drug • P2a data • Pancreatic Cancer

Preliminary phase I safety and activity of IMM-1-104, an orally dosed universal RAS inhibitor that drives deep cyclic inhibition of the MAPK pathway at MEK, in patients with advanced unresectable or metastatic solid tumors (ESMO 2024) - P1/2 | "Disrupting MAPK-pathway addicted tumors at MEK with IMM-1-104 using a novel DCI approach was well tolerated and demonstrated lesion and molecular level responses as monotherapy in an advanced, heavily pretreated phase 1 patient population. Phase 2a is underway."

Clinical • Metastases • P1 data • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor

Near-Term Milestone Expectations (GlobeNewswire) - "IMM-1-104: Initial 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; IMM-6-415: Initial pharmacokinetic (PK), pharmacodynamic (PD) and safety data from the Phase 1 portion of the Company’s Phase 1/2a trial is expected by year end."

P1 data • P2a data • PK/PD data • Solid Tumor

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 (GlobeNewswire) - P1/2a | N=210 | NCT05585320 | Sponsor: Immuneering Corporation | "Initial Results from Phase 2a Arm Evaluating IMM-1-104 with Modified Gemcitabine/nab-Paclitaxel in First Line Pancreatic Cancer as of September 12, 2024:...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% (2/5) and disease control rate of 80% (4/5), with the other three patients earlier in the course of treatment and all five continuing on treatment....Based on safety data to date, the trial’s Data and Safety Monitoring Board (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."

DSMB • P2a data • Trial status • Pancreatic Cancer

Immuneering Reports Second Quarter 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "Near-Term Milestone Expectations: (i) IMM-1-104: Initial data from multiple arms of the Phase 2a portion of the Company’s Phase 1/2a trial expected in 2H 2024; (ii) IMM-6-415: Initial pharmacokinetic (PK), pharmacodynamic (PD) and safety data from the Phase 1 portion of the Company’s Phase 1/2a trial expected in 2H 2024."

P1 data • P2a data • PK/PD data • Solid Tumor

Immuneering Granted FDA Fast Track Designation for IMM-1-104 in First-line Pancreatic Cancer (GlobeNewswire) - "Immuneering Corporation...today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for its lead clinical-stage program, IMM-1-104, as a first-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC)....Our Phase 2a study also includes an arm evaluating IMM-1-104 as monotherapy in first and second-line pancreatic cancer patients, along with monotherapy arms focused on RAS mutant melanoma and RAS mutant non-small cell lung cancer. We look forward to sharing initial data from multiple arms of the study this year."

Fast track • P2a data • Gastrointestinal Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Activity of IMM-1-104 alone or in combination with chemotherapy in RAS-altered pancreatic cancer models (AACR 2024) - P1/2 | "To test combinations with approved chemotherapy agents, IMM-1-104, gemcitabine (GEM) and nab-paclitaxel (PAC) and 5-fluorouracil (5FU) were evaluated in tumor xenograft models with drugs alone or across multiple combinations.Summary of New Data: IMM-1-104 showed promising combination effects when treated with GEM or PAC in 3D-TGA pancreatic cancer models. The Phase 2a portion of the ongoing IMM-1-104 clinical study includes five arms, three of which focus on patients with pancreatic cancer, where IMM-1-104 will be evaluated as both monotherapy and in select combinations with approved chemotherapeutic agents. The new in vitro, in vivo and ML modeling data presented here further support an advancing translational roadmap for IMM-1-104 in pancreatic cancer."

Combination therapy • Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

IMM-1-104 is Synergistic with Chemotherapy in Pancreatic Cancer Models (GlobeNewswire) - "Immuneering Corporation...presented preclinical data at the American Association for Cancer Research (AACR) Annual Meeting....IMM-1-104 showed promising combination effects when treated with gemcitabine (GEM), paclitaxel (PAC) or fluorouracil (5FU) in 3D-tumor growth assay (TGA) pancreatic cancer models. IMM-1-104 was synergistic with chemotherapy in animal models of pancreatic cancer. In a human pancreatic cancer cell line (MIA PaCa-2) tumor xenograft model, IMM-1-104 alone showed greater tumor growth inhibition (TGI) and better durability than any single or combination chemotherapy tested."

Preclinical • Pancreatic Cancer