Mabwell: The clinical trial application of 9MW2921 for injection was accepted by the State Food and Drug Administration

On February 2, Mabwell announced that the company's innovative antibody conjugate drug (ADC) variety based on the new antibody conjugation technology platform IDDCTM, and the clinical trial application of 5MW9 for solid tumors was accepted by the National Medical Products Administration (NMPA).

9MW2921 is a new generation of antibody conjugate drug molecule (ADC molecule) developed by Mabwell based on the novel antibody conjugation technology platform IDDCTM (Interchain-Disulfide Drug Conjugate) for the treatment of solid tumors. It is composed of innovative antibody molecules, novel linkers and novel payloads (TOP1i), with completely independent intellectual property rights. After injection into the body, 9MW2921 can bind to antigens on the surface of tumor cells and enter tumor cells, and through specific enzymatic hydrolysis, small molecules can be released in a targeted manner, so as to achieve precise killing of tumors.

9MW2921 has pharmaceutical characteristics such as stable structure, uniform composition, high purity, and easy industrial amplification. Compared with ADC varieties of the same type under development at home and abroad, 9MW2921 has been significantly improved and enhanced in endocytic activity, plasma stability, drug release characteristics, and bystander killing effect. In vivo efficacy studies have shown that 9MW2921 shows better tumor killing. In the safety evaluation models of cynomolgus monkeys and rats, the target-related toxicity and off-target toxicity of 9MW2921 were effectively controlled, showing that it had good drug safety and pharmacokinetic properties.

Next-generation ADC technology platform

The new generation of ADC fixed-point coupling technology platform IDDCTM independently developed by Mabwell consists of a number of systematic core patented technologies such as fixed-point coupling process DARfinityTM, fixed-point linker IDconnectTM, new load molecule MtoxinTM, and conditional release structure LysOnlyTM, which can give ADC drugs better structural uniformity, quality stability, efficacy and tolerability. At present, the advantages of the IDDCTM platform have been proven in several varieties under investigation, and it is expected that 2023-2024 ADC varieties will enter clinical development from 3 to 5.

Mabwell has developed several ADC technology platforms, among which the Nectin-4 ADC innovative drug 9MW2821 is in clinical stage.