Porton Advanced’s End-to-End Bacterial Vector CDMO Solution Accelerates FDA Approval of Salvectors’ Innovative Oncolytic Bacteria Therapy

September 19, 2025 – Porton Advanced proudly announces its client Salvectors has received Investigational New Drug (IND) clearance for their proprietary and innovative oncolytic bacteria therapy, “YB1-X7 Injection,” from the U.S. Food and Drug Administration (FDA). This milestone represents the first FDA-approved clinical candidate utilizing a next-generation synthetic biology chassis strain, succeeding the legacy VNP20009, and signifies a breakthrough in oncolytic Salmonella therapeutics.

As the exclusive CDMO partner for the project, Porton Advanced provided comprehensive CMC services, including strain construction, process development,GMP production, quality studies, release testing, and regulatory submission support. Utilizing a fully closed and integrated production process, Porton Advanced ensured the stability, activity, and safety of the samples. Leveraging its robust testing capabilities, Porton Advanced facilitated thorough purity test and quality control for the product. Additionally, an innovative purification method was employed to effectively remove process-related impurities while maintaining high product recovery rates and strain viability.

Throughout the project, the two teams maintained close collaboration, capitalizing on their respective expertise to substantially accelerate the IND application process for the YB1-X7 injection.

Porton Advanced has extensive experience in live bacterial therapeutics, including Gram-negative and Gram-positive bacteria, as well as aerobic and anaerobic bacteria. Salvectors' strong integration of synthetic biology technology platforms, along with its exceptional research and development and operational capabilities, played a key role in achieving this milestone. The FDA's approval of the YB1-X7 injection for clinical trials serves as a strong validation of Salvectors' leadership in strain engineering and highlights Porton Advanced's top-tier CDMO platform for bacterial therapy.

About Salvectors

Shaoxing Salvectors Biotechnology Ltd.(former name:Shanghai Salvectors Biotechnology Ltd.) is a biotechnology company committed to developing new drugs for solid tumors using its drug delivery platform based on the YB1-v3.0 Salmonella bacteria as a carrier.
Since its establishment in 2022, under the Founder Dr. Bin YU . Our first-in-class product YB1-X7, has obtained the IND approvals from US FDA,and has launched IIT clinical trials for a variety of malignant solid tumors in China.

About Porton Advanced

Porton Advanced Solutions is a subsidiary of the leading CDMO, Porton Pharma Solutions. Porton Advanced has headquarters in Cranbury, New Jersey, and two GMP sites in Suzhou, China, providing end-to-end CDMO solutions for ATMPs. We offer services from cell banking, process, and analytical method development, cGMP production to fill & finish, covering different stages of drug development from early research, IITs, Investigational New Drug (IND) applications, clinical trials, New Drug Applications (NDA), to commercialization.

Porton Advanced has developed specialized CRO and CDMO platforms focusing on plasmids, viral vectors (lentiviral vector, adenoviral vector, AAV,etc), cell therapy CMC services including CAR-T, TCR-T, CAR-NK, HSC, exosome, etc) and nucleic acid therapies. Our state-of-the-art, GMP-compliant facilities span an impressive 215,000 sq ft, equipped with 10 viral vector production lines, 12 GMP-compliant cell therapy production suites (including 2 suites for infectious donors), and a multitude of clean rooms. As of now, we have successfully supported our clients to secure 20 global IND approvals from NMPA, FDA, and Medsafe, with 5 ongoing Phase I/II ATMP projects. Additionally, Porton Advanced has supported the successful transition of several overseas clinical-stage pipelines into China.

Porton Advanced is committed to a customer-centric approach, offering excellent global, end-to-end CDMO services to our clients, enabling effective drugs to benefit the public sooner.