Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HER2-targeted monoclonal antibody (mAb), HLX22, in-licensed from AbClon, Inc. The drug is set to be tested in a Phase II study, exploring its efficacy when combined with trastuzumab plus chemotherapy or combined with trastuzumab deruxtecan in HER2-expressing solid tumors.
HLX22 Development for Gastric and Breast Cancer
HLX22 is under development to treat gastric cancer, breast cancer, and other solid tumors. It has previously completed a Phase I study in advanced solid tumors in China. The upcoming Phase II study will build upon these initial findings, investigating the potential synergistic effects of HLX22 in combination with other HER2-targeted therapies.
Preclinical Research and Synergy with Trastuzumab
Preclinical research results have indicated that the combination of HLX22 and trastuzumab, another HER2-targeted mAb, produces a synergistic effect, leading to better tumor suppression compared to the use of either drug as a monotherapy. This suggests that the combination therapy may offer enhanced efficacy in treating HER2-expressing tumors.
Combination with Trastuzumab Deruxtecan and Safety Profile
Additionally, preclinical animal trials of HLX22 combined with trastuzumab deruxtecan, an HER2-targeted antibody drug conjugate (ADC) approved in the US, China, Europe, and other regions, have shown synergistic anti-tumor effects and a good safety profile. This combination therapy strategy holds promise for improving treatment outcomes in patients with HER2-expressing solid tumors.-Fineline Info & Tech
