- Salvectors has received IND clearance in China for its oncolytic bacteria therapy YB1-X7 Injection, following a previous IND clearance in the United States.
- Porton Advanced served as the exclusive CDMO partner for the program, providing CMC development, GMP manufacturing, quality testing, and regulatory support.
Porton Advanced announced that its client Salvectors has received Investigational New Drug (IND) clearance from the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) for YB1-X7 Injection, an oncolytic bacteria therapy. According to the company, YB1-X7 has now secured IND clearance in both China and the United States, allowing the program to advance into global clinical development.
Porton Advanced served as the exclusive CDMO partner for the project and provided a range of chemistry, manufacturing, and controls (CMC) services. These included strain construction, process development, GMP manufacturing, quality studies, release testing, and regulatory submission support.
The company stated that it used an integrated production process designed to support the stability, activity, and safety of the product. Porton Advanced also conducted purity testing and quality control activities and implemented a purification approach intended to remove process-related impurities while maintaining product recovery rates and strain viability.
According to Porton Advanced, the company has experience supporting bacterial therapeutic programs involving Gram-negative and Gram-positive bacteria, as well as aerobic and anaerobic strains. Its service offerings include microbial banking, aseptic filling and finishing, and support for investigator-initiated trials and IND programs through collaborations with CRO partners.
Porton Advanced said its integrated CDMO platform is intended to help biotechnology companies advance bacterial therapeutic candidates from research through clinical development.
