TAbS








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Field Description
Record category Top-level status of current development.
Record category: Approved Currently approved as a therapeutic agent and marketed in at least one country.
Record category: Withdrawn Product was approved by at least one regulatory agency, but subsequently removed from all markets.
Record category: Regulatory review The first marketing application was submitted to a regulatory agency in any country.
Record category: Clinical Currently undergoing evaluation in humans as an investigational drug.
Record category: No development reported No development activity has been reported within the past ~2-3 years.
Record category: Terminated Asset has been administered to humans, but all clinical development by any company has ceased.
Record category: IND Asset for which an IND has been submitted, but clinical studies have not yet started.
Record category: Preclinical Asset is in preclinical development; focus is on molecules that may enter clinical study within 1-2 years.
Number Unique database identification number.
Status check Most recent date that data for the record was added or updated.
INN International non-proprietary name assigned by the World Health Organization.
Drug code(s) Codes assigned by any company involved in the development of the molecule.
Brand name Name used for marketing an approved product.
mAb sequence source Indicates whether the mAb is human, humanized, chimeric, murine, or a combination of these. TBD = to be determined. When the category is separated by a backslash (/) the information refers to variable domains on the same molecule. When the category is separated by a comma, the information refers to different components of a mixture.
General Molecular Category Top-level category of the molecule, such as antibody-drug conjugate, bispecific, immunoconjugate, mixture, radio-immunotherapy.
Format, general category Top-level category for the antibody format, such as full length, appended Ig, fragment. TBD = to be determined.
Format details Additional details for format, when known, such as scFv, Fab, VH. The details are separated by commas and ordered from broad to fine detail. Format synonyms are listed in alphabetical order. TBD = to be determined.
Target(s) Antigen or antigens targeted by the antibody. The target(s) for the antibody portion of the molecule are first, in the order: target(s) on tumor/non-immune-cell, in alphabetical order; target(s) on immune cell, in alphabetical order; followed by cytokine/chemokines targets, in alphabetical order; and the target for the fused non-antibody portion of the molecule, if any are known.
Isotype (Fc) Indicates the immunoglobulin isotype, if known.
Light chain isotype Kappa, lambda, or a combination of these, if known.
Linker Indicates the type of linker used in antibody-drug conjugation.
Ave. DAR Drug-to-antibody ratio for antibody-drug conjugates.
Conjugated/fused moiety Indicates the molecule conjugated or protein partner fused to the antibody portion of an antibody-drug conjugate or an immunoconjugate.
Description/comment Further details about the molecule and links to relevant data sources.
Discovery method/technology Indicates the method or technology used to create the molecule, such as hybridoma, human B-cell derived, transgenic mouse, phage or yeast display, if known.
Anticipated events Indicated forecasted events, such as investigational new drug application filing or marketing application submission, or planned or pending clinical studies.
Most advanced stage of development (global) Detailed data for the current status of the molecule, such as the most advanced phase of clinical development in any country, top countries of approval or regulatory review (e.g., EU, US, Japan, China), highest phase when terminated.
Status Indicates top-level status, such as active, no development reported, inactive.
Start of clinical phase Indicates the earliest known date for entry into clinical study, which may be either an investigational new drug application filing in any country or a first-in-human study start date. Date may be for a Phase 1/2 study if no Phase 1 study was done.
Start of first Phase 2 Indicates the start date for the first Phase 2 study in any indication. Date may be for a Phase 1/2 study if a Phase 1 study was previously completed.
Start of first Phase 3 Indicates the start date for the first Phase 3 study in any indication. The date may be for the start of a Phase 2/3 study if a Phase 3 study was not previously started.
Indications of clinical studies Diseases for which the antibody was evaluated as a treatment. Indications are entered in chronological order as the studies are started, i.e., the most recent unique indication will appear first in the list.
Primary therapeutic area Therapeutic area of the majority of clinical studies of the investigational antibody therapeutic.
Company Company that originated the molecule, if known, or the company conducting clinical development.
Licensee/Partner Company that licensed the molecule or a development partner of the company conducting clinical development.
Comments about company or candidate Notable events that occurred during the development of the molecule. Data is entered in chronological order, i.e., the most recent event will appear first in the list.
Factor(s) contributing to discontinuation Reasons for termination, if known, such as safety, lack of efficacy, business decision.
Year of first approval (global) Year the product was first approved in any country.
Date BLA/NDA submitted to FDA Date the first marketing application was submitted to the US Food and Drug Administration.
Date of first US approval Date of the first approval by the US Food and Drug Administration.
INN, US product name International non-proprietary name assigned by the World Health Organization and the non-proprietary name assigned by the US Food and Drug Administration.
US or EU first approved indications Indication first approved by the Food and Drug Administration or European Commission; may also include indications of supplemental approvals.
Full address of company Postal address of the company that originated or is developing the molecule.
Country of the company Country in which the headquarters of the company that originated or is developing the molecule is located.
Region of country Region where the headquarters of the company that originated or is developing the molecule is located.
Company website URL of the company website.


General Molecular Classification System

Detail 1


Additional Molecular Classification Details

Detail 2


Further Molecular Classification Details

Detail 3

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