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On August 20, 2024, NEWISH's self-developed HPV therapeutic nucleic acid drug NWRD08 achieved a breakthrough in the Phase I registrational clinical trial conducted at Peking Union Medical College Hospital. The first subject—a patient with recurrent HSIL (cervical high-grade squamous intraepithelial lesion) positive for HPV16—tested negative for HPV16 and showed benign histopathological regression of HSIL within 12 weeks after one course of treatment with NWRD08, with complete lesion clearance!
NWRD08 is a proprietary product independently developed by NEWISH.First-in-Class Nucleic Acid New DrugTargeting the two high-risk HPV subtypes with the strongest carcinogenic risk, HPV16 and HPV18, the aim is to eliminate the HPV virus and reduce the grade of precancerous lesions. The Phase I clinical study titled "Evaluation of the Safety and Tolerance of NWRD08 in Patients with HPV16/18-Positive Cervical HSIL," conducted at Peking Union Medical College Hospital in Beijing, is a formally registered clinical study under the National Medical Products Administration (NMPA). It received implied permission for clinical trials from the Center for Drug Evaluation (CDE) in October 2023 and officially obtained the drug clinical trial approval notice. As of August 2024, this clinical trial has completed enrollment for two dosage groups. Among them, the first subject observed a downgrade of HSIL histopathology to regression after completing one course of treatment. This means that the first subject successfully regressed from cervical high-grade lesions caused by high-risk HPV subtype infection to cervicitis, achieving a reduction in high-grade precancerous lesions and reaching the clinical endpoint!The first subject was a woman of childbearing age (currently 29 years old), who enrolled in a clinical trial at Peking Union Medical College Hospital in May 2024. She received intramuscular injections of NWRD08, administered once every four weeks at a dose of 1 mg, for a total of three doses. During the 12-week follow-up examination, the subject not only tested negative for HPV E6E7 mRNA but also showed a downgrade from high-grade lesions to cervical inflammation in the cervical tissue biopsy, indicating the clearance of high-grade precancerous lesions. The patient had undergone a cold knife conization five years ago, but the HPV16 virus was not eliminated. A follow-up examination in March 2024 revealed a recurrence, with cervical HSIL lesions reappearing. According to standard clinical treatment protocols, the patient would require a second invasive cervical conization surgery. By participating in the Phase I clinical trial of NWRD08, the patient avoided a potentially invasive second cervical conization procedure, reducing both physical and psychological burdens while ensuring no adverse impact on future fertility.The uniqueness of NWRD08 lies in the internationally pioneering strategy of targeted enhancement using conjugated chemokines. Targeting the oncogenes E6 and E7 of HPV16 and HPV18 subtypes as antigens, a recombinant fusion plasmid drug is formed by linking the target antigen with a "unique" chemokine. Administered through injection into the deltoid muscle of the upper arm, after entering human muscle cells, it can transcribe and translate the relevant antigens. The chemokine facilitates targeted delivery to human dendritic cells (DCs), enabling rapid and efficient cross-presentation of antigens. This activates T cells specifically targeting HPV16/18 E6E7, selectively eliminating HPV-infected cells to achieve systemic clinical clearance of HPV. Preclinical studies have demonstrated that NWRD08 is highly safe, strongly immunogenic, and capable of achieving non-invasive, safe, and efficient clearance of HPV viruses and associated lesions.Dr. Wang Xudong, co-founder of NEWISH, stated, The enrollment of other subjects in this clinical trial is still ongoing successively. Subjects have shown good drug tolerance. The main adverse events were mild to slight pain with low scores at the injection site, and all pain subsided spontaneously within 72 hours. No other adverse events related to NWRD08 administration were observed, demonstrating excellent clinical safety of the drug.NEWISH is full of confidence and anticipation for the subsequent clinical trials of NWRD08, believing that with the ongoing in-depth research, it can bring good news to more HPV-infected individuals and achieve new breakthroughs in the field of cervical precancerous lesion treatment.Source: NEWISH Biotechnology
