Potravitug Clinical Naked monospecific

Antibody Information

Entry ID	299
INN	Potravitug
Status	Clinical
Drug code(s)	AntiBKV, MTX-005, mAb129
Brand name	None
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	BK virus
Indications of clinical studies	BK virus infection
Primary therapeutic area	Infectious diseases

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 2/3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	May 15, 2022
Start of Phase 2
Start of Phase 3	April 10, 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	Memo Therapeutics AG
Licensee/Partner	None
Comments about company or candidate	May 2023: Fast track designation granted by FDA NCT05769582 Phase 2/3 study BKV Infection in Kidney Transplant Recipients is started in April 2023. May 31, 2022 – Memo Therapeutics AG announced today the initiation of a phase 1 clinical study targeting BK polyomavirus (“BKV”) infection in renal transplant patients. The phase 1, single-blind, partially randomized, placebo-controlled study will assess safety, tolerability, and pharmacokinetics of single and multiple ascending intravenous doses of MTX-005 in up to 56 healthy adult volunteers (ClinicalTrials.gov Identifier: NCT05358106). NCT05358106 Phase 1 started in May 2022; BLA expected in 2024.
Full address of company	Wagistrasse 27 8952 Schlieren / Zurich Switzerland Europe Switzerland https://memo-therapeutics.com/contact.html

Description/comment

AntiBKV is a fully human highly neutralising antibody against BKV; derived from clinically selected convalescent BKV patients

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None