Dezhan Health (000813): Significant Progress In Cooperation Projects Of Subsidiaries

In order to promote the prevention of cervical cancer, HPV vaccination has been widely concerned. Now, the world's first DNA therapy drug for cervical precancerous lesions is also expected to be on the market.

Breakthrough progress of subsidiary cooperation projects

On the evening of March 4, Dezhan health (000813) announced that the company received a letter of notification from Beijing dongfanglue Biomedical Technology Co., Ltd. (hereinafter referred to as "dongfanglue") on March 3. Inovio pharmaceuticals, an American partner of dongfanglue, was informed, Inc. (NASDAQ: iNO) (hereinafter referred to as "inovio") announced the positive results of the first phase III clinical trial (reveal1) of vgx-3100 and cellectratm5psp in the treatment of HPV-16 / 18 related cervical high squamous intraepithelial lesion (HSIL) jointly developed with dongfanglue, and achieved the primary and all secondary endpoints of clinical efficacy in all evaluable subjects.

It has been disclosed that vgx-3100 is a key cooperative development project between dongfanglue and inovio company in the field of DNA immunotherapy, which is used to treat precancerous lesions caused by human papillomavirus (HPV). Dongfanglue has the exclusive right to develop, produce and commercialize its products in Greater China (mainland China, Hong Kong, Macao and Taiwan), and has obtained the third phase clinical trial batch of CFDA in China Three phase clinical trials are being carried out in China.

At present, two international multi center phase III clinical trials are being carried out, including the reval 1 (critical phase III trial) and rev EA L2 (the confirmatory phase III trial) to evaluate and verify the safety, tolerance, immunogenicity and efficacy of vgx-3100. Real 1 is a randomized, double-blind, placebo-controlled clinical study in which 201 patients with HPV-16 / 18 associated cervical high-grade squamous intraepithelial lesions were recruited.

In this reveal1 study, a total of 201 subjects (ITT) were enrolled in this study. Among them, 8 subjects dropped out and no final data was obtained. The number of evaluable subjects was 193 (mitt).

The primary end point was the proportion of HSIL pathological changes and HPV16 / 18 virus clearance at 36 weeks. In the evaluable subject population, the results were 23.7% (31 / 131) in the treatment group and 11.3% (7 / 62) in the placebo group, which were statistically significant (P = 0.022; 95% CI: 0.4, 22.5), reaching the primary endpoint. The secondary end points of clinical efficacy were also achieved, including: a) cervical HSIL lesions turned to normal tissues and HPV16 / 18 virus clearance; b) only cervical HSIL lesions turned to normal tissues; c) cervical HSIL lesions turned to normal tissues; d) only HPV 16 / 18 virus was cleared. In terms of safety, the number of serious adverse reactions related to treatment was 0. Most of the adverse reactions could be relieved by themselves, and could be classified into mild to moderate range, which was consistent with the early clinical trials.

The world's first DNA therapy drug for cervical precancerous lesions

The significance of the progress of this project is that once approved for marketing, vgx-3100 will be the world's first non-surgical treatment for HPV related precancerous lesions (cervical precancerous lesions, anal precancerous lesions, vulvar precancerous lesions, etc.) and the world's first DNA drug. At present, there is no treatment other than surgery for the three indications in the world, and the drug treatment is blank for the time being.

HPV, the full name of human papillomavirus, is one of the most common infectious diseases. There are more than 200 known subtypes of HPV, which can be divided into low-risk type and high-risk type according to pathogenicity. High risk HPV can cause precancerous lesions in genital tract, anus, vulva, head and neck. Without medical intervention, it is possible to develop into cancer. Among them, high-risk HPV16 and HPV18 are the most prominent, causing 70% - 80% of cervical cancer.

According to statistics, the number of patients with cervical precancerous lesions in China has exceeded 10 million, increasing by millions every year. Now the only effective treatment is surgical resection. Once launched, vgx-3100 will provide non-surgical treatment options for patients with cervical precancerous lesions caused by HPV infection.

On March 1, 2021, inovio announced the positive results of the first phase III clinical trial of vgx-3100 for cervical precancerous lesions.

Inovio said that the phase III trial, real 1 (critical phase III test) and real 2 (confirmatory phase III test), were in progress to evaluate and verify the safety, tolerance, immunogenicity and efficacy of vgx-3100. The data of real 1 trial showed that the effective rate of the treatment group was significantly higher than that of the control group, with statistical significance. The primary endpoint and secondary endpoint were all achieved.