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The world’s first DNA drug is expected to be launched
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The world’s first DNA drug is expected to be launched!
The first phase III clinical success of an innovative drug for the treatment of cervical cancer.
On March 1, 2021, Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced the positive results of the first phase III clinical trial of VGX-3100 for cervical precancerous lesions. In a double-blind, placebo-controlled phase III clinical trial, the primary endpoint and all secondary endpoints of clinical efficacy were achieved for all evaluable subjects.
This is the fastest DNA therapy clinical trial in the world. If VGX-3100 is successfully marketed, it will be the world’s first DNA drug and also the world’s first drug for the treatment of cervical precancerous lesions.
This project is jointly developed by INOVIO and China’s innovative oncology pharmaceutical company: ApolloBio owns the exclusive development, production and commercialization rights of VGX-3100 in Greater China (Mainland China, Hong Kong, Macau, Taiwan). The indications include cervical , Treatment and prevention of precancerous lesions of vulva and anus caused by HPV infection.
The world’s first DNA drug is expected to be on the market
The first phase III trial yielded positive results, which greatly increased the success rate of VGX-3100 through the entire clinical trial. If successfully marketed, VGX-3100 will be the world’s first DNA drug and the world’s first therapeutic drug for cervical precancerous lesions.
According to statistics, the current number of patients with cervical precancerous lesions in China has exceeded 10 million, with an increase of millions each year. The only effective treatment now is surgical resection. Once VGX-3100 is on the market, it will provide non-surgical treatment options for patients with cervical precancerous lesions caused by HPV infection.
HPV stands for Human Papillomavirus, and it is one of the most common viruses that cause infectious diseases. There are more than 200 known HPV virus subtypes, which can be divided into low-risk and high-risk types according to pathogenicity.
High-risk HPV can cause precancerous lesions in the genital tract, anus, vulva, head and neck, etc. Without medical intervention, there is a possibility of progression to cancer. Among them, high-risk HPV16 and HPV18 are the most prominent, causing 70 %-80% of cervical cancer.
The INOVIO announcement shows that REVEAL 1 (critical phase III trial) and REVEAL 2 (confirmative phase III trial) of this phase III trial are in progress, aiming to evaluate and verify the safety, tolerability, and immunogenicity of VGX-3100 Sex and effectiveness.
Data from the REVEAL 1 trial showed that the effective rate of the treatment group was significantly higher than that of the control group, which was statistically significant, reaching the primary endpoint and all secondary endpoints.
Dr. Yang Weiping, co-founder and CEO of Orient Strategy, said: “It is great to see VGX-3100 making significant progress in Phase III clinical trials. This is a milestone. The Phase III clinical trial jointly promoted by Orient Strategy and INOVIO in China is also progressing smoothly. We will continue to work hard to get approval for the market as soon as possible and provide treatment options other than surgery for the vast number of female patients in China.”
Dr. J. Joseph Kim, President and CEO of INOVIO, said: “INOVIO is very proud of VGX-3100 as the first phase III clinical trial of DNA therapy. All evaluable subjects reached the efficacy endpoint. Once approved, VGX- 3100 will bring important treatment options for patients with HPV-16/18-related diseases. The effectiveness and safety data of REVEAL 1 also shows the potential of INOVIO as an important technology platform in the field of DNA therapy.”
Dr. Mark Einstein, the principal investigator of the REVEAL 1 trial, said: “This is an extremely important non-surgical treatment option for young women with HPV-related cervical cancer. direction.”
Patients with vulvar cancer and anal cancer will also benefit
Compared with the well-known cervical precancerous lesions, anal precancerous lesions and vulvar precancerous lesions are two other diseases caused by HPV infection, and they are more difficult to treat. Take precancerous lesions of the anus as an example.
The traditional treatment methods for this disease are surgical resection, electrocautery or laser treatment. Up to 50% of patients will relapse within one year of surgical treatment, which greatly affects the quality of life and health of the patients. VGX-3100 is also very expected to become the world’s first therapeutic drug for precancerous lesions of the vulva and precancerous lesions of the anus in the future.
INOVIO announced in early January this year: For the precancerous lesions of the vulva caused by HPV infection, the second phase of clinical trials showed good clinical effectiveness, safety and tolerability. Another indication is anal precancerous lesions caused by HPV infection. Its phase II clinical trial also showed positive effectiveness and safety.
The subjects were 23 adult male and female patients. After 6 months, 50% (11/22) of the patients got remission. The indication plans to apply for orphan drug certification this year and initiate a global phase III clinical trial.
VGX-3100, as a key R&D project of Oriental Strategy and INOVIO in the field of DNA immunotherapy, once approved, it will be the first in the world to be developed for the treatment of HPV-related precancerous lesions (cervical precancerous lesions, anal precancerous lesions, vulvar precancerous lesions). Precancerous lesions) non-surgical treatment.
Globally, there is currently no treatment other than surgery for these three indications, and drug treatment is temporarily blank.
Develop biomarkers to improve effectiveness
Dr. Prakash Bhuyan, Senior Associate Director of INOVIO and Head of HPV Therapy Clinical Development, said: “Thank you to our investigators, trial center staff, and patients for their support to make this possible. For the development of this new type of health improvement for women We are very excited about the treatment.
At the same time, we and QIAGEN continue to work together to plan to develop a biomarker diagnostic product that cooperates with the treatment of VGX-3100, which will more effectively identify patients.”
INOVIO announced in February this year that it will continue to cooperate with QIAGEN to develop an in vitro diagnostic product based on RNA sequencing technology in order to more effectively identify the patient population that responds to VGX-3100. This is extremely important for the VGX-3100 project and market expansion.
This technology has been used in the evaluation of VGX-3100 phase II clinical data. Among the VGX-3100 subjects with HPV16/18-related cervical precancerous lesions, 85 % Of subjects with biomarkers are effectively treated.
INOVIO stated that it will continue to follow up the safety and durable response rate of REVEAL1 subjects for 18 months after the last dose. The results of REVEAL 1 data will be presented at this year’s scientific conference.
(source:internet, reference only)