October 23, 2015
By Alex Keown, BioSpace.com Breaking News Staff
THOUSAND OAKS, Calif. – Amgen ’s investors are waiting with bated breath for a ruling from the U.S. Food and Drug Administration (FDA) for its oncolytic virus therapy T-Vec, talimogene laherparepvec.
Amgen’s cancer therapy was recommended by an advisory panel to the U.S. Food and Drug Administration in April and the regulatory agency is expected to make a ruling on the drug by Oct. 27. T-Vec is a cancer therapy built out of a herpes simplex virus that has been engineered to produce granulocyte macrophage colony-stimulating factor (GM-CSF), a growth factor that stimulates stem cells to produce immune cells. As an immunotherapy, T-Vec is injected directly into tumors. There, it replicates inside the tumor cells, causing them to rupture and die. The cancer cell rupture releases tumor-derived particles along with GM-CSF, which stimulates the immune system to attack the cancer cells. In clinical tests, T-Vec has shrunk tumors but it has not yet been shown to extend lives.
Earlier today T-Vec cleared a regulatory hurdle in Europe. The European Medicines Agency (EMA), the pharmaceutical regulatory agency in the European Union, approved T-Vec for the treatment of melanoma. The drug, which will be called Imlygic in Europe, is being recommended for the treatment of skin cancers that cannot be removed by surgery, Reuters reported.
Amgen is up this morning, trading at $153.77 per share.
Amgen acquired T-Vec from BioVex for about $1 billion in 2011.
If T-Vec is approved in the United States, it will face a market with several new treatments for melanoma, including Yervoy and Opdivo from Bristol-Myers Squibb Company and Merck & Co. ’s Keytruda, which are checkpoint inhibitors, that act to inhibit cancer cells’ ability to block the body’s immune reaction. Some researchers believe that combining a checkpoint inhibitor that slows down a tumor’s ability to block immune responses with an oncolytic that accelerates the body’s immune response, will dramatically improve cancer treatments.
But, T-Vec will also help pave the way for other drugs, including Genelux’s lead drug candidate, GL-ONC1, which is being tested in clinical trials for head and neck cancer, mesothelioma and ovarian cancer, Forbes reported. San Diego-based Genelux is helmed by Thomas Zindrick, a former Amgen veteran. Zindrick told Forbes the company was “heartened by the fact that Amgen had achieved a milestone in the oncolytic viral field that proves the concept Amgen is really setting the regulatory precedents, and ultimately the physician-practice precedents for us.”
Unlike T-Vec, which is injected directly into a tumor, GL-ONC1 is being designed to be delivered intravenously.
U.K.-based Replimune Ltd. is also working on similar oncolytic immunotherapy treatment.
In addition to Genelux, other drug companies reported working on cancer-fighting viruses similar to V-Tec include Oncolytics Biotech Inc. (ONC.TO), SillaJen and Targovax .
