Anti-DM1/DM4 payload antibody in PK study in ADC drug development

To specifically address the pharmacokinetics of ADCs that contain DM1 or DM4, the anti-DM1/DM4 antibodies are considered efficient tools for these investigational purposes. DM1; maytansinoid DM1 DM4 maytansinoid DM4 are highly effective microtubule depolymerising agents, applied in ADCs to destroy cancer cells.

**Product list of GeneMedi's anti-DM1/DM4 antibody**
Cat No.	Product Description	Fc	Products Information
GTU-Bios-Maytansinoids-Ab	Anti-DM1/DM4 (Maytansinoid) human monoclonal antibody (mAb)	hFc/mFc	Details

All Payloads of ADCs

Application

Competitive immunoassay validation (Competitive ELISA) and other Immunoassay,
PK & PD assay for MMAE payload of Antibody-drug Conjugate (ADC)

Highlight:

Purity: ≥95% (SDS-PAGE)
High affinity and specificity validated
High sensitivity verified by ADCs binding assay

Application
Technical Resource

Why Use Anti-DM1/DM4 Antibody in ADC drug development?

Quantification of Conjugated Payload: Anti-DM1/DM4 antibodies enable characteristic identification and evaluation of the amount of the payload still bound to the antibody. This is important in order to understand how much of the drug can still interact with the antibody after some time which is very important especially in the deterministic of safety of the particular drug.
Assessment of Stability: It also uses these antibodies to determine the stability of the ADC using the rate of payload release or commonly referred to as deconjugation rate. This information is essential to evaluate the shelf-life of the ADC and ensure that the correct dosing schedules are utilized.
Understanding Pharmacokinetics: Since, ADC and free payload can be quantii ed sepa- rating from each other, it becomes possible to study the distribution, metabolism and excretion of both species. This aids in determining the personalized plasma concentrations (therapeutic window) and safety margins of the ADC.
Biodistribution Studies: There are always issues on biodistribution of the ADC and its payload, that is, where the ADC and the payload is in the body, which tissues or organs it builds up in, and how it is cleared.

How to use Anti-DM1/DM4 Antibody in ADC drug development?

ELISA and Other Immunoassays: 170 Another well-known use of the anti-DM1/DM4 antibodies is in enzyme-linked immunosorbent assays (ELISA) to capture the ADC from biological samples. This gives information on the time course of the concentration of the ADC and its payload in blood or in any other tissues.
Immunohistochemistry: In tissue studies, they may be used to localize ADCs anatomic structures within different tissues. It assists in the determination of the targeting precision and the ADC penetration depth within tumor tissues.
Mass Spectrometry: In tissue studies, they may be used to localize ADCs anatomic structures within different tissues. It assists in the determination of the targeting precision and the ADC penetration depth within tumor tissues.
Development and Validation of Assays: In early development these antibodies are important to establish challenging, reliable and specific biochemical assays for both preclinical and clinical testing.

This evidence means that the employment of anti-DM1/DM4 antibodies in PK studies then gives information that is important in contours, dosage, and accrual for ADCs. This is a very crucial function as they have to ensure that the therapeutic agents used get to the target organ or site while at the same time ensuring that the agents indeed work optimally while at the same time causing as little harm as possible to the patient.