Fujifilm Diosynth Biotechnologies (FDB) and Istari Oncology have entered into an agreement for the manufacturing of Istari Oncology’s viral immunotherapy, PVSRIPO, currently being investigated for the treatment of solid tumors.
 
Fujifilm Diosynth Biotechnologies is a contract development and manufacturing organization (CDMO) with experience in the development and manufacture of recombinant biopharmaceuticals and viral gene therapies. Istari Oncology is a clinical-stage biotechnology company focused on novel immunotherapies for the treatment of solid tumors.
 
Istari Oncology selected Fujifilm Diosynth Biotechnologies as its partner for drug substance manufacturing and filling of its recombinant viral immunotherapy PVSRIPO, which is based on the Sabin Type 1 poliovirus vaccine. Drug substance manufacturing and filling will be carried out in Fujifilm Diosynth Biotechnologies’ state-of-the-art cGMP manufacturing facility in College Station, TX. Manufacturing at FDB will support Istari Oncology’s three ongoing clinical trials being conducted across six potential indications including glioblastoma, melanoma, bladder cancer, and head and neck cancer, as well as studies planned in the future.
 
“Our decision to collaborate with Fujifilm Diosynth Biotechnologies on the manufacturing of PVSRIPO has already paid off in multiple ways,” said Jamie Iudica, chief manufacturing officer, Istari Oncology. “Despite manufacturing constraints other biotechnology companies have experienced due to the pandemic, FDB has demonstrated a patient focused mindset and has continued to support Istari by working tirelessly to identify and mitigate supply risks for our clinical trials.”
 
Gerry Farrell, chief operating officer, Fujifilm Diosynth Biotechnologies, Texas site, said, “We are proud of our role as a manufacturing partner to Istari Oncology. Supporting the supply of potential therapies to oncology patients is at the core of what we do every day. Our entire FDB team is honored to be playing a critical part of the clinical journey of PVSRIPO.”