Process development and quality control will begin in 2021, and full manufacturing capabilities at the 88,000-square-foot facility will be available in 2023.
Viral immunotherapies company Oncorus announced earlier this week that it will begin building a GMP facility this year to manufacture its pipeline as its candidates move into IND-enabling and clinical studies. Process development and quality control will begin in 2021, and full manufacturing capabilities at the 88,000-square-foot facility will be available in 2023. The facility is part of the company’s near-term focus on operational and manufacturing scale-up, which president and CEO Ted Ashburn called a “strategic priority for Oncorus going forward.”
Oncorus has signed a 15-year lease for the facility located in Andover, Mass. The announcement, following a $98 million IPO in October 2020, comes as the company advances several programs through its pipeline. In addition to its lead program, which began Phase I testing in 2020, the company expects to nominate three clinical candidates in 2021. ONCR-177, its lead oncolytic herpes simplex virus (oHSV)-based immunotherapy, is in human trials as a monotherapy and in combination with Merck’s Keytruda (pembrolizumab) for a range of solid tumors. Testing in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic modal solid tumors began in July.
The company is also developing an oHSV candidate for central nervous system cancers like glioblastoma multiforme, as well as a viral immunotherapies for coxsackievirus and Seneca Valley virus using a synthetic virus platform.
As Oncorus builds the infrastructure needed, and as needed thereafter, it will continue to utilize contract manufacturing organizations, all with the goal of scaling up for potential commercial launch support, says Chief Operations Officer and Chief of Staff Steve Harbin. In particular, he says, “This facility will give us control over quality and output and enhanced flexibility as we develop our multiple oHSV- and synthetic virus-based viral immunotherapy programs.” Harvin joined Oncorus in December after stints at Eli Lilly, Moderna, and bioMérieux SA.
At least one other company is developing next-generation oncolytic virus-based immunotherapies. Last month, Turnstone Biologics announced the launch of clinical trials for RIVAL-01/TAK-605, its oncolytic vaccinia virus-based cancer immunotherapy, developed in conjunction with Takeda. Amgen won the first and only Food and Drug Administration (FDA) approval for an oncolytic viral therapy, for its first-generation modified HSV Imlygic (talimogene laherparepvec), approved for melanoma in 2015.
Oncorus’ stock opened at $32.45 Monday, up $0.28 from the market close last Thursday.
