China introduces the first therapeutic vaccine against HPV precancerous lesions

Recently, Beijing Oriental Biomedical Technology Co., Ltd. (ApolloBio) announced an exclusive cooperation agreement with Inovio Biopharmaceutical Company of the United States. ApolloBio will invest $35 million in the development and commercialization rights of Inovio's immunotherapy program for human papillomavirus (HPV), the VGX-3100, in China, including Taiwan, Hong Kong and Macau.

The world's first therapeutic vaccine against HPV precancerous lesions

VGX-3100 is a specific immunotherapy for HPV. It is the world's first therapeutic vaccine against HPV precancerous lesions. It is in clinical stage III. Its indications include precancerous lesions, abnormal proliferation and cancer caused by HPV infection.

According to World Health Organization (WHO) data, cervical cancer is the second most common cancer among women in developing countries and one of the most deadly cancers. Human papillomavirus (HPV) is the main cause of cervical cancer, and 70% of cervical cancer and cervical cancer precancerous lesions are associated with HPV-16 and 18 viruses.

There are currently no approved non-surgical treatments for HPV persistent infections or cervical precancerous lesions. Traditional surgical treatment achieves therapeutic goals by removing precancerous lesions or cancerous tissue, but there is a risk of postoperative bleeding, infection, and recurrence.

VGX-3100 treats HPV-induced cervical precancerous lesions by activating HPV-16 and type 18 virus infection by activating antigen-specific CD8+ T cells. VGX-3100 showed good therapeutic efficacy and tolerability in clinical phase II trials with no side effects and surgical-related obstetric risks. VGX-3100 is expected to reduce the risk of cervical cancer while avoiding surgical treatment.

中国引入首个针对HPV癌前病变的治疗性疫苗

35 million transaction amount

Under the terms of the cooperation and licensing agreement, ApolloBio will pay for all clinical development costs of the VGX-3100 in China. Inovio will receive $15 million in pre- and near-term advance payments, $20 million in regulatory milestone payments (including the US, Korea and China) and a net sales commission of no less than 10%.

Once the FDA lifts the clinical ban on the VGX-3100 Phase III trial, ApolloBio will pay a recent advance payment of $12 million. The VGX-3100 project was suspended because the FDA required additional data to indicate the shelf life of the disposable parts of the Cellectra5PSP immunotherapy delivery device.

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