Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 989 |
| INN | Volrustomig |
| Status | Clinical |
| Drug code(s) | MEDI5752 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa/lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CTLA-4, PD-1 |
| Indications of clinical studies | Head and neck cancer, Pleural Mesothelioma, Hepatobiliary Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma, Non-small cell lung cancer, Advanced Renal Cell Carcinoma, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 24, 2018 |
| Start of Phase 2 | November 01, 2019 |
| Start of Phase 3 | September 15, 2023 |
| 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 | NCT06129864 Phase 3 in Head and Neck Squamous Cell Carcinoma started in December 2023. NCT06097728 Phase 3 in pleural mesothelioma started in Nov 2023. NCT06079671 Phase 3 in cervical cancer started in Sep 2023 NCT05984277 Phase 3 in NSCLC started in Oct 2023. NCT05061550 Phase 2 in NSCLC started in April 2022. Listed as having moved to Phase 2 between Q3 and year end 2019 in AZ update released in Feb 2020 (https://www.astrazeneca.com/content/dam/az/PDF/2019/full-year/Full-year_and_Q4_2019_results_clinical_trials_appendix.pdf). NCT03530397 is A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects With Advanced Solid Tumors started in April 2018 still recruiting as of Aug 2019 |
| Full address of company | Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html |
Immune checkpoint inhibitor. Dovedi S, et al. MEDI5752: A novel bispecific antibody that preferentially targets CTLA-4 on PD-1 expressing T-cells [Abstract]. Presented at American Association for Cancer Research 2018 Annual Meeting, Chicago. 16 April 2018. MEDI5752 is a monovalent bispecific human IgG1 monoclonal antibody (mAb) with an engineered fragment crystallisable (Fc) domain to reduce Fc effector function, that specifically binds two clinically validated negative T cell regulators; PD-1 (programmed cell death 1) and CTLA-4 (cytotoxic T-lymphocyte-associated protein 4). http://cancerres.aacrjournals.org/content/78/13_Supplement/2776. Immunoglobulin G1 [134-cysteine,228-valine,242-phenylalanine,243-glutamic acid,339-serine,362-cysteine,374-tryptophan] anti-CTLA4; immunoglobulin G1 [239-phenylalanine,240-glutamic acid,336-serine,354-cysteine,371-serine,373-alanine,412-valine] anti-PD1
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |