Overview
Suzhou, China – On October 27, 2023, RinuaGene Biotechnology Co., Ltd. (hereinafter referred to as "RinuaGene") announced that it has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its proprietary HPV-related therapeutic mRNA vaccine, RG002. This groundbreaking vaccine is indicated for the treatment of cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3) associated with human papillomavirus (HPV) types 16 and/or 18. It marks the first mRNA lipid nanoparticle (LNP) therapeutic vaccine globally approved to initiate clinical trials for this indication. RinuaGene is concurrently advancing its clinical trial application with the National Medical Products Administration (NMPA) in China.
HPV infection, particularly types 16 and 18, is a primary cause of cervical pre-cancerous lesions and cervical cancer. The persistent progression of these lesions can ultimately lead to the development of cervical cancer, which is the fourth most common malignancy threatening women's health worldwide [1]. Surgical interventions remain the mainstay treatment for pre-cancerous lesions; however, they are associated with significant risks, including increased rates of premature birth, miscarriage, and high rates of lesion persistence or recurrence [2]. Moreover, HPV infection is directly linked to several other reproductive system cancers, including oropharyngeal, anal, vaginal, penile, and vulvar cancers [3] [4]. Despite the availability of preventive HPV vaccines, HPV-related tumors continue to pose a widespread threat, with over 850,000 new diagnoses and nearly 450,000 deaths annually [1]. Currently, there is no approved therapeutic vaccines for HPV-related pre-cancerous lesions or malignancies worldwide.
RG002 utilizes RinuaGene's proprietary mRNA sequences and lipid nanoparticle (LNP) delivery system, optimized through multiple patented technologies, including antigen design, sequence optimization, and regulatory elements. This delivery system demonstrates high efficiency and excellent safety profiles. Preclinical studies indicate that RG002 alone can induce strong, specific cellular immunity and tumor cell-killing effects, effectively inhibiting the growth of HPV-related tumors. When combined with immunotherapy agents such as immune checkpoint inhibitors, RG002 shows promising synergistic effects.
The preclinical data provides a robust foundation for RG002's use in treating HPV-related pre-cancerous lesions and malignancies. RinuaGene is committed to efficiently advancing the clinical development of RG002, aiming to establish a comprehensive clinical trial program for various indications worldwide. The company is actively exploring the potential monotherapy or combination therapy of RG002 in treating cervical pre-cancerous lesions, cervical cancer, head and neck squamous cell carcinoma, and rare tumors, addressing the significant clinical need for HPV-related disease therapies and benefiting patients globally.
Professor Wu Lingying, Head of the Department of Gynecologic Oncology at the Cancer Hospital of the Chinese Academy of Medical Sciences and Chair of the CSCO Gynecologic Oncology Expert Committee, stated, "The incidence of cervical cancer in China is trending younger. With the widespread implementation of early screening, more cases of pre-cancerous lesions and cervical cancer are being detected at an early stage. For patients with pre-cancerous lesions who have reproductive needs or are unsuitable for surgical treatment, a non-surgical therapeutic option is essential. For advanced cervical cancer, there has long been a lack of effective treatments, leading to poor prognoses for patients. Recent advancements in immunotherapy have made significant progress in cervical cancer; however, the efficacy of existing agents such as PD-1 monoclonal antibodies remains limited. Therefore, new therapeutic strategies are urgently needed to improve overall efficacy and survival benefits. The innovative mRNA-LNP drug RG002 developed by RinuaGene offers a novel therapeutic mechanism, leveraging immune activation against specific HPV antigens to deliver clinical efficacy. Its potential for combination with existing standard chemotherapy and PD-1 monoclonal antibodies presents a promising avenue for clinical development, garnering anticipation from both clinicians and patients."
About RinuaGene
Founded in March 2021 in the Suzhou Biomedical Industrial Park (BioBAY), RinuaGene is dedicated to developing innovative drugs and vaccines based on mRNA technology to meet significant unmet clinical needs globally. The company has established over ten pipelines, with four advancing to the IND application stage, and has initiated three IND applications, one of which has received FDA IND approval. We extend our gratitude to all partners, investors, and BioBAY for their ongoing trust and support. RinuaGene will continue to advance the global development of its pipelines and upgrade its technology platform efficiently.
RinuaGene possesses comprehensive independent intellectual property rights and a global patent portfolio, having submitted over 30 invention patents and received two software copyright registrations. The company operates four major technological platforms: linear mRNA, circular RNA, novel LNP targeted delivery, and CMC. Located in BioBAY, RinuaGene features an mRNA innovation and R&D center along with a pilot cleanroom, enabling complete independent R&D and clinical production capabilities for mRNA drugs and vaccines.
Currently, RinuaGene focuses on developing therapeutic vaccines for cancer, vaccines for infectious diseases, cancer immunotherapy agents, protein replacement products, and novel delivery systems. The company remains committed to an innovative, open, cooperative, and win-win corporate culture, welcoming multi-faceted collaborations in product development, combination therapies, technology platforms, and new delivery systems to jointly promote the development and application of RNA technology across multiple fields.
References
1. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 2021;71(3):209–249.
2. Bi H, Li M, Zhao C, et al. Chinese expert consensus on the management of cervical low-grade squamous intraepithelial lesions. Chinese Journal of Clinical Obstetrics and Gynecology. 2022;23(4):3.
3. Jia X, Su Z, Li Y, et al. Research progress on epidemiology of human papillomavirus-related head and neck cancer. Chinese Journal of Public Health. 2022;38(11):5.
4. National Medical Products Administration (NMPA). Technical Guidelines for Clinical Trials of Human Papillomavirus Vaccines (Trial). 2023.