Helixmith said Wednesday that it has developed a new freeze-drying formulation for its gene therapy, Engensis (VM202), further improving advantages in its manufacturing process and obtaining a patent in the U.S.

Helixmith said it has developed a new freeze-drying formulation for its gene therapy, Engensis (VM202), enhancing its advantages in the manufacturing process and obtaining a U.S. patent.
Helixmith said it has developed a new freeze-drying formulation for its gene therapy, Engensis (VM202), enhancing its advantages in the manufacturing process and obtaining a U.S. patent.

The new formulation forms a superior cake quality and increases the stability of Engensis. According to Helixmith, cake appearance is an important characteristic of freeze-dried products, which can impact product quality regarding safety and efficacy.

The new formulation maintains a stable supercoil form of DNA, which activates Engensis, allowing the active ingredients to be administered accurately and consistently when reconstructed with a solution after freeze-drying. “This is a very important factor in the manufacture and quality management of Engensis,” a company official said.

Helixmith first acquired the formulation patent in the U.S. and has entered Korea, Japan, Europe, and China for screening by their regulatory authorities.

The U.S. patent registration of the new formulation extends the patent monopoly on Engensis until 2039. Helixmith has continuously upgraded and applied for patents for the formulation and use of Engensis.

Helixmith used the formulation in all Engensis clinical trials, including it in future biological license applications (BLA) data and the FDA approval received in March, setting up a high barrier for biosimilar developers who want to imitate Engensis, the official said.

Furthermore, the existing formulation needed help producing finished drugs because quality control was difficult to maintain. However, the new formula removes these obstacles to technology transfer and marketing authorization of Engensis, according to Helixmith.

"We have surmounted one of the biggest barriers in the future technology transfer and marketing licensing process by extending Engensis' patent monopoly and building a system capable of large-scale commercial production simultaneously," Helixmith CEO Kim Sun-young said.

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