This is what overshadows the progress of JNJ's HIV vaccine

According to Bloomberg, Johnson & Johnson (JNJ) plans to launch an evaluation trial of its mosaic-based HIV vaccine in the United States and Europe this year. The trial will include approximately 3,800 high-risk men. It will be conducted in collaboration with the US National Institute of Allergy and Infectious Diseases and the HIV Vaccine Testing Network.

On May 29, Johnson & Johnson announced the completion of the registration to its Phase 2b concept validation effectiveness study, Imbokodo. The study covers 2,600 young women and is evaluating another version of its mosaic-based HIV-1 vaccine in Africa. Society is waiting for the first readings of this trial in 2021.

HIV vaccine or HIV prophylaxis

Despite the steady increase in use of Truvada, HIV prevention treatment (pre-exposure prophylaxis) from Gilead Sciences in the United States, and generic versions of Truvada in the European Union, the market HIV vaccine remains considerable.

According to HIV.gov estimates, an estimated 1.8 million new HIV-1 patients were infected in 2017. The World Health Organization estimates that 940,000 people are living with HIV-1-related illnesses. HIV in 2017. In this context, a vaccine must be taken once to obtain immunity – instead of PrEP against HIV, which requires strict adherence to a dosing regimen – can significantly improve the rate of prevention HIV.

According to the International AIDS Vaccine Initiative, even a 70% effective HIV-1 vaccine, combined with the use of PrEP and antiretroviral therapies, can result in a significant reduction in new HIV-1 infections. 1.

In April, Johnson & Johnson submitted a new drug application seeking approval for a monthly injectable antiretroviral maintenance treatment for HIV-1.

Criminal investigation on talc

Despite positive developments in the area of ​​HIV, JNJ closed Friday at $ 134.30, down 4.15% from yesterday's close. This decline follows a Bloomberg report revealing the opening of a criminal investigation by the United States Department of Justice into the company's dishonest communication with the public about the potential cancer risks of its talcum powder for the cancer. This investigation adds to the multiple civil suits in which plaintiffs accuse the company's talc of provoking cancer. To learn more, read Why Johnson & Johnson was down 2% this morning.

This report overshadowed Johnson & Johnson's clinical progress in the area of ​​HIV vaccines.

Darzalex subcutaneous formula

On Friday, Johnson & Johnson also submitted a request for FDA approval for a subcutaneous formulation of Darzalex for multiple myeloma patients who have already received at least three lines of treatment, including an IP ( proteasome inhibitor) and an IMiD (immunomodulatory drug), or who relapsed after treatment with IP and IMiD. The news of criminal research eclipsed this positive development.