RinuaGene, a leading mRNA specialist headquartered in Suzhou, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its human papillomavirus (HPV) associated tumor therapeutic mRNA vaccine, RG002. This marks a significant step forward in the development of the vaccine, which will be evaluated in clinical trials for the treatment of Grade 2 or 3 cervical intraepithelial neoplasia (CIN2/3) associated with HPV types 16 and/or 18. In addition to the US IND approval, RinuaGene is progressing with an IND filing for RG002 in China.
RG002’s Proprietary Technology and Preclinical Performance
RG002 utilizes RinuaGene’s proprietary mRNA Sequence and Lipid Nanoparticle (LNP) Delivery System, which has been optimized based on multiple patented technologies. These include antigen design, sequence optimization, and regulatory elements that enhance the vaccine’s efficacy. Preclinical studies have demonstrated that RG002 monotherapy can elicit strong specific cellular immunity and tumor cell killing effects, effectively inhibiting HPV-related tumor growth. The vaccine also shows promising synergistic effects when used in combination with anti-tumor drugs, such as immune checkpoint inhibitors.
Potential Applications and Clinical Assessments
RG002 is anticipated to be assessed in a range of clinical settings, including cervical precancerous lesions, cervical cancer, head and neck squamous cell carcinoma, and rare tumors. The vaccine may be evaluated as a monotherapy or in combination with other treatments, offering potential new avenues for treatment and prevention of HPV-associated cancers.-Fineline Info & Tech
