Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 238 |
| INN | Botensilimab |
| Status | Clinical |
| Drug code(s) | AGEN1181 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CTLA-4 |
| Indications of clinical studies | Pancreatic cancer, Colorectal cancer, Melanoma, Advanced cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2 pivotal |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2018 |
| Start of Phase 2 | November 30, 2022 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Agenus Inc. |
| Licensee/Partner | None |
| Comments about company or candidate | Nov 2024: Ongoing discussions with the European Medicines Agency (EMA) have progressed to agreement on dose selection and trial design for the pivotal Phase 3 study in MSS CRC, marking significant progress in BOT/BAL’s development. In addition, Agenus will explore registration paths for BOT/BAL in r/r MSS CRC with regulatory authorities in other geographies, including the UK, Canada, Australia, Israel, and Brazil. Phase 3 Study in r/r MSS CRC: Agenus has gained alignment with the FDA on the proposed design and dosing regimen for its upcoming Phase 3 study in the r/r MSS CRC treatment setting and intends to initiate this study soon. FDA Interaction: While the FDA discouraged the submission of interim results for Accelerated Approval based on the dataset shared with them during the July End-of-Phase 2 meeting, Agenus plans to further engage the FDA with more mature data to support its AA strategy. Jan 2024: NCT06279130 Phase 2/3 of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors started in Jan 2024, but sponsor is non-commercial. May 2023 presentation: BLA anticipated in 2024. (https://investor.agenusbio.com/static-files/3fd0754b-cb11-45bc-96db-e3c1d7fd1b2c) Apr 2023: FDA grants Fast Track Designation for the combination of botensilimab (AGEN1181) and balstilimab (AGEN2034). The designation is for patients with non-microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer with no active liver involvement. NCT05608044 Phase 2 started in Nov 2022 NCT05630183 Phase 2 started in Feb 2023 NCT05529316 Phase 2 started in Dec 2023; NCT05571293 Phase 2 has non-commercial sponsor. Expansion of Phase 2 (?) may not have actually occured, as the company is still discussing the start of Phase 2 study in May 2022. Dec 1, 2020: Agenus Inc. announced the expansion of a Phase 2 trial into colon cancer based on a new objective clinical response in a colorectal cancer patient in addition to a significant tumor reduction of 27% and biomarker reduction observed in a patient with MSS colon cancer. This may not have actually occured, as the company is still discussing the start of Phase 2 study in May 2022 May 2019: April 2, 2019: Agenus Inc. an immuno-oncology company with a pipeline of immune-modulating antibodies, cancer vaccines, adjuvants and adoptive cell therapies, announced that the first patient was dosed in the clinical trial of its next-generation anti-CTLA-4 antibody (AGEN1181). AGEN1181, a novel 'Fc engineered' antibody with potential for enhanced anti-tumor functions, is specifically designed to boost cancer killing immune cells and deplete cells that block the activity of these cancer killing cells. NCT03860272 Phase 1 first administration on April 2, 2019. IND filed in Nov 2018. http://agenusbio.com/wp-content/uploads/2018/12/Agen_Year-End-2018.pdf |
| Full address of company | Lexington, MA 02421-7305 North America United States of America https://agenusbio.com/ |
Immune checkpoint target. A novel Fc-engineered IgG1 anti-CTLA-4 human monoclonal antibody; https://www.cell.com/cancer-cell/fulltext/S1535-6108(18)30219-8
| Anticipated events | In discussion with agencies re. regulatory submission; combo with balstilimab |
| Factor(s) contributing to discontinuation | None |