Japan's Oncolys BioPharma wants to muscle in on Amgen's cancer-killing virus for melanoma. The biotech has filed to start trials of its version in U.S. melanoma patients, just a few months after the Amgen product was cleared by the FDA.
Tokyo-based Oncolys is seeking approval for a Phase II trial of Telomelysin (OBP-301) in patients with advanced melanoma that cannot be treated using surgery--a similar indication as Amgen's Imlygic, which was approved by the FDA last October.
The so-called oncolytic virus therapy is designed to be injected directly into tumors, infecting and killing malignant cells while stimulating the release of antigens that direct immune responses to the cancer. The modified viruses are engineered to replicate only in cancer cells, leaving healthy cells unscathed.
Telomelysin is a genetically engineered adenovirus that has already completed a Phase I safety study in 16 individuals with a range of solid cancers. Published in Nature, the trial found preliminary evidence of tumor shrinkage and cancer cell-directed immune responses after a single injection.
Imlygic--previously known as T-Vec--was the first oncolytic virus therapy to be approved in the U.S. It has since won a green light in the EU, but has gotten off to a slow start in the market.
Amgen has not started breaking out sales of the drug in its financial reporting yet, lumping it in alongside other drugs that collectively made just $17 million in the second quarter of the year. That's not unexpected, however, given the niche patient population currently addressed by the drug as a single-agent therapy, according to the U.S. biotech.
Amgen's commercial chief, Anthony Hooper, recently said he believed the "true potential" of the therapy will be unlocked if it gets approved for use alongside immuno-oncology drugs, such as the PD-1/PD-L1 checkpoint inhibitors, in multiple tumor types.
Checkpoint inhibitors such as Merck & Co.'s Keytruda and Bristol-Myers Squibb's Opdivo have helped revolutionize the treatment of melanoma, but the majority of melanoma patients still do not respond to them.
Oncolys is eyeing the same combination treatment opportunity, and says it will press ahead with studies of Telomelysin with checkpoint inhibitors in the U.S. if its first Phase II trial comes up positive. The Japanese firm has just set up a U.S. subsidiary to spearhead Telomelysin development and forge partnerships with clinical testing sites.
Analysts have suggested that Imlygic will be a relatively minor product for Amgen, with peak annual sales of around $200 million, but there seems to be a considerable appetite among pharma companies to explore the potential of the technology.
Several companies are developing oncolytic virus-based therapies, including Oncolytics Biotech, Transgene, Profectus/Vyriad and the Australian biotech Viralytics. Meanwhile, Pfizer has just bought into the category via a licensing deal with Western Oncolytics.
Pfizer bags option on oncolytic virus, partners up to advance through PhI
Oncolys in license deal with Jiangsu Hengrui on OBP-301
Amgen wins quick EU approval for Imlygic, its first-in-class immuno-oncology drug
Amgen's Imlygic becomes first re-engineered virus to earn FDA approval as a cancer fighter
Japan's Oncolys begins PhI trial of cancer drug licensed from Astellas