USA – FUJIFILM Diosynth Biotechnologies (FDB) and Istari Oncology have announced that they have reached an agreement for the manufacture of PVSRIPO, a viral immunotherapy being developed by Istari Oncology for the treatment of solid tumors.
FUJIFILM Diosynth Biotechnologies is a premier Contract Development and Manufacturing Organization (CDMO) with extensive experience in the development and manufacturing of recombinant biopharmaceuticals and viral gene therapies.
Istari Oncology chose Fujifilm Diosynth Biotechnologies as its partner for drug substance manufacturing and filling of PVSRIPO, a recombinant viral immunotherapy based on the Sabin Type 1 poliovirus vaccine.
PVSRIPO is a novel viral immunotherapy that has been genetically modified to be fully neuro-incompetent and incapable of harming healthy cells. It is based on the Sabin type-1 polio vaccine.
Normally, poliovirus can only infect and enter cells by binding to CD155, a protein found on their surface.
PVSRIPO capitalizes on the discovery that CD155 levels are abnormally high in certain cancer cells, such as glioblastoma, and has been found to play an important role in tumor cell migration, invasion, and metastasis.
When PVSRIPO is administered to the tumor site, the modified poliovirus infects and eventually kills tumor cells that produce CD155.
Manufacturing and filling of drug substances will take place at Fujifilm Diosynth Biotechnologies’ state-of-the-art Current Good Manufacturing Practice (cGMP) manufacturing facility in College Station, Texas.
FDB’s manufacturing will support Istari Oncology’s three ongoing clinical trials in six potential indications, including glioblastoma, melanoma, bladder cancer, and head and neck cancer, as well as planned future studies.
Commenting on this partnership, Jamie Iudica, chief manufacturing officer, Istari Oncology said: “Our decision to collaborate with Fujifilm Diosynth Biotechnologies on the manufacturing of PVSRIPO has already paid off in multiple ways.”
“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.”