Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 479 |
| INN | Anselamimab |
| Status | Clinical |
| Drug code(s) | CAEL-101, Ch mAb 11-1F4 |
| Brand name | None |
| mAb sequence source | mAb chimeric |
| 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) | Amyloid light chain |
| Indications of clinical studies | Amyloid light chain amyloidosis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 01, 2014 |
| Start of Phase 2 | March 15, 2020 |
| Start of Phase 3 | November 12, 2020 |
| 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 | AstraZeneca |
| Licensee/Partner | None |
| Comments about company or candidate | Listed as Phase 3 asset in AZ pipeline dated Nov 2024. Key Phase 3 read-out in AL amyloidosis in 2025 (NCT04504825, NCT04512235). Fast track designation as per Q3 2022 results presentation (https://www.astrazeneca.com/content/dam/az/PDF/2022/Q3/Year-to-date_and_Q3_2022_results_clinical_trials_appendix.pdf) AstraZeneca (acquired Caelum Biosciences and Alexion (formerly Syntimmune)) July 2021: Ongoing enrollment in the CAELUM CARESPhase 3 program with enrollment in both trials expected to complete by 2022. Aug 2020: Alexion Pharmaceuticals, Inc. and Caelum Biosciences today announced the initiation of the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care (SoC) therapy in AL amyloidosis. The CARES clinical program includes two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease – and will collectively enroll approximately 370 patients globally. Enrollment is underway in both studies. The primary objective of the clinical program is to assess overall survival. NCT04504825 started in Feb 2021 has primary completion date in 2024 and NCT04512235 Phase 3 study started in Nov 2020 has primary completion date in March 2025. December 2, 2019 – Caelum Biosciences, Inc. (“Caelum”), a company focused on developing treatments for rare and life-threatening diseases, today announced that the European Commission (EC) has granted orphan medicinal product designation to CAEL-101 (previously known as 11-1F4), a light chain fibril-reactive monoclonal antibody (“mAb”), for the treatment of amyloid light chain (“AL”) amyloidosis. January 31, 2019: Alexion Pharmaceuticals, Inc. and Caelum Biosciences today announced a collaboration to develop CAEL-101 for light chain (AL) amyloidosis. CAEL-101 is a first-in-class amyloid fibril targeted therapy designed to improve organ function by reducing or eliminating amyloid deposits in patients with AL amyloidosis June 25, 2018 – Caelum Biosciences, Inc. today announced a complete analysis of cardiac data from Columbia University’s (“Columbia”) Phase 1b trial that supports CAEL-101’s (mAb 11-1F4) potential to improve myocardial function as assessed by global longitudinal strain (“GLS”) and generate a sustained decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in amyloid light chain (“AL”) amyloidosis patients experiencing cardiac involvement. These data were presented at the American Society of Echocardiography (ASE) 29th Annual Scientific Sessions. December 11, 2017 – Caelum Biosciences, Inc. (“Caelum”) today announced full Phase 1a/1b clinical data demonstrating CAEL-101’s (mAb 11-1F4) ability to bind to light-chain amyloid fibrils and achieve early and clinically efficacious organ responses in patients with relapsed and refractory amyloid light chain (“AL”) amyloidosis. The data were presented by Columbia University (“Columbia”) on December 10th in an oral session at the 59th American Society of Hematology (“ASH”) Annual Meeting. Caelum in-licensed CAEL-101 from Columbia and recently completed a Phase 1a/1b clinical trial at Columbia for the treatment of AL amyloidosis, a rare systemic disorder that causes misfolded amyloid proteins produced by plasma cells to cause buildup in and around tissues, nerves and organs, gradually affecting their function.The Phase 1a/1b study (ClinicalTrials.gov Identifier: NCT02245867) is examining the tolerance, safety, pharmacokinetics and possible clinical benefit of CAEL-101, a chimeric fibril‐reactive monoclonal antibody (mAb), in patients with AL amyloidosis. January 4, 2017 – Fortress Biotech, Inc. (Nasdaq: FBIO) today announced the formation of a new subsidiary company, Caelum Biosciences, Inc., to advance the development of CAEL‐101 (11‐1F4) for the treatment of amyloid light chain (“AL”) amyloidosis. Caelum has entered into an agreement with Columbia University (“Columbia”) to secure exclusive worldwide license rights to CAEL‐101, a chimeric fibril‐reactive monoclonal antibody (mAb) currently being evaluated in a Phase 1a/1b study. CAEL-101 has received Orphan Drug Designation from the U.S. Food and Drug Administration as a therapy for patients with AL amyloidosis and as a radio-imaging agent in AL amyloidosis. |
| Full address of company | Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html |
produced in a Chinese hamster ovary (CHO)-DG44 cell line
| Anticipated events | Marketing application possible for AL amyloidosis in 2025? |
| Factor(s) contributing to discontinuation | None |