Beijing’s Apollobio, has announced that the National Medical Products Administration (NMPA) has granted market approval for its innovative therapeutic vaccine VGX-3100. This vaccine, which targets HPV-16/18 related anal precancerous lesions, is a significant advancement in the treatment landscape for conditions associated with Human Papillomavirus (HPV).
The vaccine’s approval follows a successful Phase II clinical trial, which demonstrated that VGX-3100, when used in conjunction with fluorouracil and platinum-based chemotherapy, met both primary and secondary endpoints. The primary endpoint focused on the vaccine’s safety, while the secondary endpoint evaluated preliminary efficacy. The trial showed a dose-dependent effect on forced vital capacity (FVC), a key indicator of lung function improvement in patients with idiopathic pulmonary fibrosis (IPF).
VGX-3100 is a first-in-class small molecule inhibitor that targets TNIK (Traf2- and NCK- interacting kinase) and is designed to enhance the activation of effector T cells and improve immune regulation within the tumor microenvironment. The vaccine’s approval comes after it was previously approved for the treatment of cervical precancerous lesions, marking a milestone in the company’s commitment to addressing HPV-related diseases.- Flcube.com
