November 2, 2021

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Istari Oncology Enters Agreement with FUJIFILM Diosynth Biotechnologies


by Chantal Allam, NCBiotech Writer — November 1, 2021.

DURHAM – A Duke University spinout is partnering with FUJIFILM Diosynth Biotechnologies (FDB) to manufacture its promising new cancer treatment.

Six months after a massive $43.4 million raise, Istari Oncology, a clinical-stage biotech company headquartered in Durham, has entered into an agreement with the Japan-based biologics manufacturer with a large presence in the Triangle.

It entails manufacturing its immune-boosting technology, Polio Virus Sabin-Rhinovirus Poliovirus (PVSRIPO), that uses variations of the polio vaccine to treat patients with cancer.

“Our decision to collaborate with FDB on the manufacturing of PVSRIPO has already paid off in multiple ways,” said Jamie Iudica, Istari’s chief manufacturing officer.

“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.”

Drug substance manufacturing and filling will be carried out in FDB’s cGMP manufacturing facility in College Station, Texas.

Istari said the agreement will also support its 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.

Founded in 2014, the company raised $43.4 million in April from 17 investors. It came on the heels of receiving clearance from the U.S. Food and Drug Administration for its investigational immunotherapy.

Results from multiple trials and preclinical research streams indicate that PVSRIPO has the potential to treat just about every solid tumor.

Once injected, the company said it activates a patient’s adaptive and innate immune system to attack the cancer.

“If a tumor can be biopsied, it can be injected,” W. Garrett Nichols, M.D., MS, the chief medical officer at Istari Oncology, has told North Carolina Biotechnology Center. “And if it can be injected, it can elicit an antitumor immune response that has the potential to control or eliminate the tumor.”

Separately, FUJIFILM Diosynth Biotechnologies is expanding in the Triangle, with the construction of a new $2 billion facility in Holly Springs. The company has said it will be the largest end-to-end biologics production facility in the world upon its completion.

groundbreaking ceremony at the site of the company’s new facility took place in October.

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