Creo SG successfully optimizes production of AIDS vaccine for US FDA phase 2 clinical trial, secures agreement on phase 2 synopsis, enables rapid clinical trials’

Creo SG developed the world’s first AIDS vaccine ‘SAV001-H’
Production testing of US Food and Drug Administration (FDA) phase 2 clinical samples
It was announced on the 15th that it was successfully completed.

Creo SG for clinical use
We plan to accelerate the development of SAV001-H by simultaneously conducting sample production and clinical trial-related preliminary procedures.

Creo SG signed a contract with Naobios, a global contract development and manufacturing (CDMO) company, to produce SAV001-H clinical samples early this year.

Under the contract, Creo SG transferred its technology for its own production process, and NaoBios
After successfully applying Creo SG’s culture method to existing facilities, we succeeded in discovering additional optimized conditions.

SAV001-H is a killed vaccine that detoxifies the entire structure of HIV (human immunodeficiency virus) and uses it as an antigen, and is effective in inducing neutralizing antibodies.

AIDS is incurable and the number of patients is steadily increasing, but AIDS is still prevalent worldwide.
There are no cases of vaccine development.

Because AIDS mutates very rapidly, neutralizing antibodies are induced against the mutant strain and the virus
It is important to determine which structure induces neutralizing antibodies.

HIV itself is dangerous, so a high level of biological safety must be maintained.
Do it.

SAV001-H is an HIV treatment based on genetic recombination technology.
It is characterized by being attenuated and undergoing a total of two inactivation processes to ensure that it is not only safe but also minimizes the impact of vaccine antigens.

Already with the US FDA and ‘Type C’
Phase 2 clinical trial synopsis through ‘Meeting’
The company explained that because consent has been obtained, it will be able to quickly enter full-scale clinical procedures after mass production.

Creo SG developed SAV001-H
To accelerate the process, various procedures are being carried out in parallel with sample production.

Recently, a consulting agreement was signed with a local expert to proceed with phase 2 clinical trials in the U.S., and a global
Phase 2 IND (clinical trial plan) with contract research organization (CRO) ‘Fortrea’
Getting ready.

To expand the AIDS vaccine pipeline, we are also developing a combination vaccine based on our own general-purpose vaccine development platform ‘SUV-MAP’.

Creo SG
Western University in Canada is conducting animal tests to evaluate the efficacy of the combined vaccine.

A Creo SG official said, “Creo SG’s
Based on production process design capabilities and NaoBios’ virus culture technology, we successfully tested for HIV production.
“In addition to HIV sample production, preliminary information related to clinical trials was carried out,” he said.
“We will accelerate preparations and speed up the commercialization of the world’s first AIDS vaccine,” he emphasized.

He continued, “SAV001-H has already
In the phase 1 clinical trial, antibodies increased significantly by up to 512 times.
It lasts for 12 months, and neutralizing antibodies against various mutations are formed.
“We have confirmed that there is high interest from global pharmaceutical companies,” he said. “We plan to pursue global technology transfer after successfully completing the FDA phase 2 clinical trial.”
added.