Volrustomig Clinical Bispecific

Antibody Information

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

Therapeutic information

Target(s)	CTLA-4, PD-1
Indications of clinical studies	Colorectal cancer, 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

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

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 information

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

Description/comment

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

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None