Shanghai, August 13, 2024 - Luye Pharma Group today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) application for an mRNA-based therapeutic vaccine codenamed LY01620 developed by its subsidiary Jimai Biological Technology. The vaccine is intended for treating the high-grade squamous intraepithelial lesion (HSIL) of the cervix associated with human papillomavirus genotype 16 (HPV 16). In China, HPV 16 is the most common type of HPV associated with cervical cancer, accounting for 59.5% of all cases.¹

There isn’t any therapeutic HPV vaccine marketed in the world as of today. LY01620 is the first investigational drug developed by Jimai Biological Technology based on the company’s own mRNA sequences and delivery system for lipid nanoparticles (LNPs). It has the potential to treat HPV infections across different stages. 

Limitations of existing prophylactic HPV vaccines

Cervical cancer is the most common one among the top three gynecological cancers and the fourth leading cause of cancer-related death for women.² HPV is a very common sexually transmitted virus. Persistent infections with high-risk HPV (HR-HPV), including the HPV16 subtype, are preconditions for the development of cervical cancer and its precursor lesions.³ 

All existing HPV vaccines are prophylactic in nature, designed to prevent HPV infections in naïve population through the induction of specific antibodies. But they can’t eradicate established HPV infections or treat associated pathologies. Consequently, prophylactic vaccination following persistent HPV infections provides no benefit for patients. Besides, HPV vaccination rates have been historically low in China, leading to high risks of HPV infections in the population. 

Therapeutic HPV vaccines are urgently needed 

The pathogenesis of cervical cancer involves a multi-stage process that includes primary infections, subclinical infections, and cervical intraepithelial neoplasia (CIN). The process typically spans five to ten years. Unfortunately, there isn’t an effective treatment available for cervical cancer in early stages, so women who are chronically infected by the virus have to endure major psychological stress. Female patients with high-grade CIN stage (CIN-2 or CIN-3) may opt for surgical treatment. However, surgery is contraindicated for women with the desire to have babies. In contrast to traditional surgical treatment, therapeutic vaccines can be used at different stages of the disease after HPV infection, thereby blocking the progression of infections to cervical cancer. Given their capacity as a non-invasive cure based on immunomodulation, therapeutic HPV vaccines are urgently needed in clinical practice to address the unmet needs.

Expected to fill a gap in therapeutic HPV vaccines

LY01620 leverages mRNA to express the HPV-specific antigens E6 and E7, thereby eliciting a robust antigen-specific T-cell response capable of eradicating the HPV-infected cervical epithelial cells. This immunotherapeutic approach is designed to block cervical carcinogenesis and restore epithelial homeostasis. Preclinical investigations have consistently demonstrated LY01620's potent immunogenicity in eliciting antigen-specific T-cell responses across diverse animal models. Furthermore, LY01620 also exhibits significant antitumor efficacy underpinned by its mechanism of action in tumor-bearing mouse models without inducing appreciable toxicity upon repeated administration, underscoring its promising efficacy and safety profiles. 

Jimai Biological Technology achieved a number of innovations in the development of LY01620, including the design and optimization of cap analogs, regulatory elements, and antigenic sequences. In addition, the company has established a unique mRNA detection methodology and a whole-process quality control system to ensure a consistently high quality standard for the vaccine. 

Cheng Guang, CEO at Jimai Biological Technology, said: “LY01620 has the potential to fill a gap in therapeutic HPV vaccines and offer a new treatment option for HPV infections. Gynecological cancers such as cervical cancer and breast cancer are major health challenges in the world. This is one of the therapeutic areas that we've been focusing on. LY01620 will further expand our oncology portfolio. It will strengthen our position in this therapeutic area, and will also make a meaningful impact on women’s health worldwide.”

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About Luye Pharma Group

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has achieved multiple innovations in new chemical entities and antibodies, and is also actively making strategic developments in the fields of cell therapies and gene therapies.

Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets -- China, the U.S., Europe and Japan, as well as in fast growing emerging markets.

About Jimai Biological Technology

Jimai Biological Technology, a subsidiary of Luye Pharma Group, is a leading innovator of drug delivery technologies for small-molecule and nucleic acid-based therapeutics. With its strong R&D capabilities, the company has multiple proprietary therapeutics under development. Its pipeline includes promising candidates for pain relievers in cancer management, mRNA vaccines, novel adjuvants, and nucleic acid drugs. It is committed to providing cutting-edge therapeutics for patients around the world. 

Jimai Biological Technology has three established platforms for nucleic acid drugs, for the delivery of nanoparticles, and for advanced materials respectively. The company has a lot of experience in designing, optimizing, synthesizing, modifying, and purifying mRNA sequences. Its expertise extends from designing sequences and screening molecules to formulating mRNA vaccines. Its proprietary technologies for cap analogs and untranslated regions (UTRs) enable high-level gene expressions, and its proprietary delivery platform for lipid nanoparticles (LNPs) ensures efficient drug delivery. Together, these capabilities position the company as a frontrunner in transforming nucleic acid science into life-changing therapies in China.

 

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