Nuowei Bio's HPV16-Associated Tumor mRNA Therapeutic Vaccine IND Application Accepted by CDE

Dec 26, 2024 20:07 CST Updated 20:07

Newish

Developer of Next-Generation Anti-Tumor DNA Vaccines

On December 26, 2024, according to the Center for Drug Evaluation of the National Medical Products Administration（CDE）Official website announcement,NEWISH Biotechnology (Wuxi) Co., Ltd.("NEWISH Bio")Developed bymRNA Cancer Therapeutic Vaccine "NWRD09 Injection"New Drug Clinical Trials（IND）Application Accepted by CDE for the Treatment of High-Risk Human PapillomavirusHPV-16 Positive/HPV-16 Related Intraepithelial Neoplasia(LSIL and HSIL), andHPV-16 Related Cervical Cancer。

Source: CDE Official Website

Cervical CancerIt is the fourth most common cancer among women globally, with over 90% of cervical cancers caused by high-risk human papillomavirus.（HPV）Caused by persistent infection. Currently, although preventive HPV vaccines have been widely used and can effectively prevent primary infections, treatment options remain limited for patients already infected with HPV. A large number of patients with precancerous cervical lesions caused by HPV infection do not receive timely, non-invasive, and effective treatment. Long-term repeated HPV infection carries the risk of progressing to cervical cancer.

TargetingHigh-grade Squamous Intraepithelial Lesion of the Cervix（HSIL）Currently, conization is recommended as the standard treatment in clinical practice. This treatment method involves the removal of part of the cervical tissue. However, due to limitations in the surgical environment, surgical operation, and pathological diagnosis, the prognosis for many patients undergoing surgery is not ideal. Many patients infected with high-risk subtypes of HPV still experience HPV recurrence and lesion relapse after surgery. This situation may be related to incomplete virus clearance during surgery or the inherent infection mechanism of HPV itself. Additionally, many individuals with recurrent HPV infections are of marriageable and childbearing age, and a significant number of patients have fertility needs. Evidence suggests that conization can impact fertility. Therefore,mRNA Therapeutic Cancer Vaccines Expected to Provide a New and Superior Treatment Approach.

Currently, there are no approved therapeutic HPV vaccines on the market.Five HPV-related tumor mRNA therapeutic vaccines have entered clinical trial stages in China., respectivelyGrand PharmaceuticalSubsidiary Aoluo BioTherapeutic tumor vaccine under developmentARC01(A002)；Afana BioAFN0328 Injection；Luye Group Subsidiary Jimai BiotechnologyLY01620；CSPC GroupSYS6026 Injection; andRenching BioRG002 Injection。

NEWISH Collaborates with Academician Jiang Jiandong from the Chinese Academy of Medical Sciences to Develop a Chemokine-Enhanced Nucleic Acid VaccineSTARi(Super-Strong Targeted Activation of T-Cell Immune Strategy)Nucleic Acid Drug Development Technology PlatformThe STARi platform enhances the efficiency of antigen uptake by antigen-presenting cells in the body through targeted delivery, thereby significantly boosting the level of T-cell immune response induced by the antigen. It can be used to develop therapeutic vaccines for cancer.(Nucleic Acid Drugs)And a new generation of antiviral vaccines, providing patients worldwide with innovative and groundbreaking therapeutic vaccines to meet unmet clinical needs.

About NEWISH

NEWISH focuses on early cancer treatment, dedicating to the research and development of immunocyte therapies and First-in-Class gene therapy drugs with complete independent intellectual property rights. It has established two technology platforms: STARi.（Super Targeting Activated Response of immunization）——A powerful nucleic acid drug platform that targets and activates T-cell immune responses, used for developing various tumor vaccine products; Newish T-cell therapy platform, autologous memory lymphocyte injection — the world's first cell therapy product approved by national drug regulatory authorities with central memory T cells as the main component, used to prevent recurrence after various solid tumor surgeries. NEWISH is committed to addressing unmet clinical needs and aims to become a global leader in the research and development of new drugs for early cancer treatment.

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