The majority of the biologics currently on the market are low-concentration formulations for intravenous infusion. Compared with intravenous infusion, subcutaneous injection exhibits convenience in administration such as lower requirements for the administration environment and thus leads to better patient compliance. Given the smaller injection volume allowed by subcutaneous injection, it is generally necessary to develop high-concentration formulations to achieve the required dosage.
Alphamab Oncology developed a proprietary platform of subcutaneous high concentration formulations. The biologics injections produced using this platform allows for long term stable storage and are suitable for subcutaneous administration. KN035, the first subcutaneously injectable PD-(L)1 inhibitor worldwide, is the first product developed by this platform.
In addition, Alphamab Oncology has extended this platform to antibody-drug conjugates (ADCs). ADCs are therapeutic drugs composed of an antibody targeting specific antigen and a payload conjugation via a linker. Due to common stability challenges in formulation, most approved ADC drugs are currently in lyophilized form, and thus require reconstitution before intravenous infusion during clinical in use. Alphamab Oncology has addressed the stability issue of ADC liquid formulations by leveraging its high-concentration formulation platform, thereby enabling subcutaneous administration for ADC drugs and further enhancing the safety and compliance of ADC therapies.
JSKN033 (co-formulation consisting of HER2 bispecific antibody-drug conjugate and single-domain antibody-Fc fusion protein targeting PD-L1) is a proprietary product developed by Alphamab Oncology using this platform. Preclinical studies data indicate that JSKN033 exhibits good safety profile after subcutaneous injection, which confirms the stability of JSKN033 in storage. This product further validates subcutaneous high concentration formulation platform is suitable for the combination therapy of ADC drugs and immune checkpoint inhibitor drugs.
