Oncorus to Build GMP Viral Immunotherapy Mfg. Facility

Oncorus, Inc., a clinical stage biopharmaceutical company developing next-gen viral immunotherapies for cancer, has signed a 15-year lease to build a state-of-the-art, 88,000 sq.-ft. GMP viral immunotherapy clinical manufacturing facility in Andover, MA.

Oncorus has a portfolio of intratumorally and intravenously administered viral immunotherapies for multiple cancer indications with significant unmet needs based on its oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform. The company is currently conducting a Phase 1 trial of its lead product candidate, ONCR-177, an intratumorally administered oHSV viral immunotherapy being developed for multiple solid tumor indications. The company anticipates interim data in 2H21 through 2H22.

The company plans to nominate its first intravenously administered synthetic virus clinical candidates (coxsackievirus A21 and Seneca Valley Virus programs) in 1H21 and its second intratumorally administered oHSV candidate, which will specifically target brain cancer, including glioblastoma multiforme, in 2H21.

The facility will provide a comprehensive solution for Oncorus’ Chemistry, Manufacturing and Controls (CMC) development needs, enabling the manufacture, quality, control and supply of clinical-grade viral immunotherapies for investigational new drug (IND)-enabling studies and clinical studies. Oncorus anticipates the first phase of the facility’s buildout will be completed in late 2021, including process development and quality control, with GMP multi-product manufacturing capabilities and full operation beginning early 2023. Oncorus plans to continue partnering with contract manufacturing organizations to provide additional support and capacity.