IMM-6-415 / Immuneering - LARVOL DELTA

IMM6415-101: A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors (clinicaltrials.gov) - P1/2 | N=30 | Completed | Sponsor: Immuneering Corporation | Recruiting ➔ Completed | N=240 ➔ 30 | Trial completion date: Jul 2027 ➔ Apr 2025 | Trial primary completion date: Jun 2027 ➔ Apr 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

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 Reports Third Quarter 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "Near-Term Milestone Expectations:...IMM-6-415: Initial PK, PD and safety data from the Phase 1 portion of the Company’s Phase 1/2a trial is expected by year end."

P1 data • PK/PD data • 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 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 Announces First Patient Dosed in its Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations (GlobeNewswire) - "Immuneering Corporation...announced that the first patient has been dosed in its Phase 1/2a trial of IMM-6-415 to treat advanced solid tumors with RAF or RAS mutations....'We look forward to sharing initial PK/PD and safety data from the Phase 1 portion of our Phase 1/2a trial in 2024'."

P1 data • PK/PD data • Trial status • Cutaneous Melanoma • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Skin Cancer • Solid Tumor

A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors (clinicaltrials.gov) - P1/2 | N=240 | Recruiting | Sponsor: Immuneering Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Immuneering Announces Positive Topline Results from Phase 1 Portion of its Phase 1/2a Clinical Trial of IMM-1-104 in RAS-Mutant Solid Tumors (GlobeNewswire) - "Near-Term Milestone Expectations: IMM-1-104: Initial data from multiple arms of the Phase 2a portion of Immuneering’s Phase 1/2a study of IMM-1-104 expected in 2024; IMM-6-415: First patient in Phase 1/2a trial of IMM-6-415 expected to be dosed in March 2024."

P2a data • Trial status • Oncology • Solid Tumor

A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors (clinicaltrials.gov) - P1/2 | N=240 | Not yet recruiting | Sponsor: Immuneering Corporation

Metastases • New P1/2 trial • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Immuneering Announces FDA Clearance of IND Application for Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations (GlobeNewswire) - "Immuneering Corporation...today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IMM-6-415, paving the way for the company to initiate a Phase 1/2a clinical trial of this oral, twice-daily small molecule, in development for the treatment of advanced RAF or RAS mutant solid tumors....'We look forward to dosing the first patient in the Phase 1/2a clinical study of IMM-6-415, which is expected in early 2024.'"

IND • New P1/2 trial • Oncology • Solid Tumor

Immuneering Presents Preclinical Data Demonstrating Encouraging Anti-Tumor Activity for IMM-1-104 and IMM-6-415 at AACR-NCI-EORTC Conference (GlobeNewswire) - "Immuneering Corporation...presented encouraging preclinical data for...IMM-6-415 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 11-15, 2023....Benchmarking of IMM-6-415 as a single agent across more than 60 patient-aligned models in humanized 3D-tumor growth assays demonstrated high sensitivity in a wide range of MAPK-driven tumor types, including models of RAS and RAF mutant disease. IMM-6-415 in combination with encorafenib drove deeper regressions and superior durability versus binimetinib plus encorafenib when compared head-to-head in animal models of RAF mutant melanoma and colorectal cancer; IND filing expected in 4Q 2023."

IND • Preclinical • Colorectal Cancer • Melanoma

Immuneering to Present Preclinical Data on IMM-1-104 and IMM-6-415 at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "Immuneering Corporation...announced that it will present preclinical data on IMM-1-104, its lead clinical-stage program, and IMM-6-415 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held October 11-15, 2023 in Boston."

Preclinical • Oncology

Deep Cyclic Inhibition of the MAPK pathway with IMM-6-415, alone and in combination with encorafenib, demonstrates anti-tumor activity and tolerability in RAF mutant tumors in vivo. (AACR-NCI-EORTC 2023) - No abstract available

Combination therapy • Preclinical • Oncology

Immuneering Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates (GlobeNewswire) - "Near-Term Milestone Expectations:...IMM-6-415: IND filing expected in the fourth quarter of 2023."

IND • Oncology

Cyclic disruption of the mitogen-activated protein kinase (MAPK) pathway by the dual MEK inhibitor, IMM-6-415, enhances PD1 and CTLA4 checkpoint blockade in RAS mutant tumors (SITC 2022) - "KRAS-G12C inhibitors (sotorasib/adagrasib) have demonstrated single-agent activity in all three tumor types. Ethics Approval The protocol and any amendment(s) or procedures involving the care and use of animals in this study were reviewed and approved by the Institutional Animal Care and Use Committee (IACUC) of CrownBio prior to execution. During the study, the care and use of animals was conducted in accordance with the regulations of the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)."

Checkpoint inhibition • IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CTLA4 • KRAS

Immuneering Reports Third Quarter 2022 Financial Results and Recent Business Highlights (GlobeNewswire) - "IND Cleared for Phase 1/2a Trial of IMM-1-104 in September 2022; Clinical Trial (NCT05585320) is Recruiting, and First Patient is Expected to be Dosed this Quarter....Second IND submission for IMM-6-415 expected in Q4 2023: IMM-6-415 is currently in IND-enabling studies. Immuneering expects to file an IND application for IMM-6-415 in Q4 2023."

Trial status • Oncology • Solid Tumor

Immuneering Presents Promising Preclinical Data on its Second Program IMM-6-415 at the 37th Annual Meeting of SITC (GlobeNewswire) - "In this preclinical study, Immuneering researchers tested IMM-6-415 alone and in combination with anti-PD1 or CTLA4 checkpoint inhibitors in a series of preclinical models to characterize single-agent activity as well as combination therapy with checkpoint inhibitors (CPIs) in RAS-mutant colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) models driven by diverse MAPK pathway mutations....'These studies demonstrate monotherapy and combination activity of IMM-6-415 across multiple RAS-mutant models. IMM-6-415 also displays a differentiated short plasma half-life of approximately 0.3 hours and was observed to be well tolerated in mice.'"

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Immuneering To Present Poster on IMM-6-415 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (GlobeNewswire) - "Immuneering Corporation...announced it will present data on its second program IMM-6-415 in a poster presentation at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place November 8-12, 2022 in Boston or virtually."

Preclinical • Oncology • Solid Tumor

Immuneering Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Updates (GlobeNewswire) - "IMM-1-104 IND submission expected in Q3 2022: Immuneering expects to file the IND for IMM-1-104 in the third quarter of 2022 and enroll the first patient in its Phase 1 dose-escalating trial evaluating IMM-1-104 in patients with solid tumors with RAS mutations in the fourth quarter of this year; IMM-6-415 IND submission expected in 2023: Immuneering recently designated IMM-6-415 as a drug candidate for its MEK-io program and is currently in IND-enabling studies...Immuneering also hosted a key external expert event to discuss this data with two leading KRAS mutation Oncologists...Dr. Anthony Tolcher..."

Oncology • Solid Tumor

Immuneering Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Updates (GlobeNewswire) - "IMM-1-104 IND submission expected in Q3 2022: Immuneering expects to file the IND for IMM-1-104 in the third quarter of 2022 and enroll the first patient in its Phase 1 dose-escalating trial evaluating IMM-1-104 in patients with solid tumors with RAS mutations in the fourth quarter of this year; IMM-6-415 IND submission expected in 2023: Immuneering recently designated IMM-6-415 as a drug candidate for its MEK-io program and is currently in IND-enabling studies...The company expects to file an IND application in 2023."

Enrollment open • IND • Oncology • Solid Tumor