Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1062 |
| INN | Denecimig |
| Status | Clinical |
| Drug code(s) | NN-7769, NNC0365-3769, Mim8 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | Duobody |
| Isotype (Fc) | IgG4 |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Duobody® platform |
| Target(s) | Factor IXa, Factor X |
| Indications of clinical studies | Hemophilia A |
| Primary therapeutic area | Cardiovascular / hemostasis disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2019 |
| Start of Phase 2 | January 10, 2020 |
| Start of Phase 3 | December 02, 2021 |
| 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 | Novo Nordisk |
| Licensee/Partner | Genmab |
| Comments about company or candidate | May 2024: Novo Nordisk aims to submit Mim8 for the first regulatory approval towards the end of 2024 (https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=168515) Phase 3 studies for Hemophilia A with or without inhibitors (NCT05306418) is recruiting as of May 22, 2023, NCT05053139 is recruiting as of June 18, 2023, NCT05685238 is recruiting as of June 18, 2023, NCT05878938 not yet recruiting as of May 30, 2023). NCT05053139 Phase 3 Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors start in Dec 2021 recruiting as of last update in Feb 2023. May 2021: Mim8 received Orphan Drug Designation from the FDA for the treatment of patients with hemophilia A. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=814121 NCT04204408 Phase 2 study started in Jan 2020; study will assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Doses of NNC0365-3769 (Mim8) in Healthy Subjects and in Subjects With Haemophilia A With or Without Factor VIII Inhibitors |
| Full address of company | Novo Alle 1, 2880 Bagsværd, Denmark Europe Denmark https://www.novonordisk.com/contact-us.html |
MiM8 is a novel, next-generation FVIII mimetic antibody that potently enhances coagulation in pre-clinical models. FVIII mimetics are bispecific antibodies bridging FIXa and FX on platelet surface, enhancing FX activation and thereby coagulation. Development of Mim8 utilized the Duobody® platform to initially screen for compatible anti-FIXa and anti-FX antibodies followed by several iterations of systematic mutational optimization. K409R and F405L mutations in IgG1 to create bispecific, then reformatted to IgG4
| Anticipated events | Marketing application submission planned toward end of 2024 |
| Factor(s) contributing to discontinuation | None |