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Maxing out with GVAX
March 2013
by Kelsey Kaustinen  |  Email the author


BERKELEY, Calif.—Building on a previous agreement, Aduro BioTech, Inc., a clinical-stage immunotherapy company, has acquired all GVAX assets from Lincolnshire, Ill.-based BioSante Pharmaceuticals Inc., including intellectual property and cell lines. The acquisition covers all uses, including GVAX Pancreas and GVAX Prostate, which Aduro had licensed before, as well as vaccines for multiple myeloma, breast and colon cancer and the rights to an existing license agreement for GVAX Melanoma. Per the terms of the agreement, Aduro paid BioSante $1 million up front for the assets, with a commitment for additional milestone and royalty payments following the commercialization of any GVAX products.  
The previous agreement between BioSante and Aduro was announced in April 2011, when Aduro licensed BioSante's Pancreas Cancer Vaccine and Prostate Cancer Vaccine solely for use in combination with its own proprietary Listeria-based vaccines. Though no specific financial terms were released, the agreement involved milestone and royalty payments for BioSante once combination cancer vaccines that used the company's vaccine technology were commercialized. Aduro also had an option to additional cancer vaccine indications of BioSante's.  
"Combinations are the future of immunotherapy, especially for cancer," Dr. Thomas W. Dubensky Jr., chief scientific officer at Aduro, said in a press release. "In addition to our efforts, other researchers have shown in early-phase pancreatic and prostate cancer clinical trials that the combination of GVAX with the approved immune checkpoint inhibitor ipilimumab improves patient outcomes. With the acquisition of GVAX, we have a unique opportunity to advance an entire portfolio of combination treatments."  
The GVAX cancer vaccines utilize human cancer cell lines that have been genetically modified to secrete granulocyte-macrophage colony-stimulating factor, an immunostimulant. The cell lines are then irradiated, which prevents cell division, yet they stay metabolically active. A number of studies are underway for the products, and the pancreatic cancer, leukemia, myeloma, breast cancer and prostate cancer vaccines are all in the late human clinical stage, with colorectal and melanoma in the early human clinical stage. BioSante has been granted U.S. Food and Drug Administration Orphan Drug designation for several vaccines, including GVAX Pancreas for the treatment of pancreatic cancer, GVAX AML for the treatment of acute myeloid leukemia, GVAX CML for the treatment of chronic myeloid leukemia and GVAX Melanoma for the treatment of melanoma.
Aduro is currently evaluating the sequential administration of the GVAX Pancreas vaccine and its own Listeria-based CRS-207 in metastatic pancreatic cancer patients. The company was very interested in the GVAX program, says Stephen Isaacs, chairman and CEO of Aduro, who notes that Aduro's own experience with cancer vaccines is "extensive."  
The Listeria monocytogenes platform is one of three at Aduro, along with GVAX and cyclic dinucleotides (CDNs), which Aduro describes on its website as "small molecules secreted by Listeria and other intracellular pathogens that signal through STING (STimulator of INterferon Genes) and induce a potent immune response." The company's Listeria approach has several advantages, such as targeting dendritic cells, signaling the innate immune system through multiple pathways and an ability to be repeatedly administered. Aduro is also combining the CDNs with GVAX into a new vaccine known as STINGVAX, which has shown to be more efficacious than GVAX alone in animal models.  
According to Isaacs, the cancer vaccine market is one that will likely continue to see growth.  
"I think some of the other therapies have really sort of hit the wall, in terms of radiation and chemotherapy and surgery; you can only really do so much. And I think a lot of the pathway-specific drugs are kind of like whack-a-moles—you knock one out and the cancer cells figure out a way to mutate around it, and then you need another one for a different pathway," says Isaacs. "So I think the whole concept of using the immune system to fight cancer—and to kind of keep cancer in check for all of us, in any case—but to actually fight it when it does occur, is a good one. It's been around for quite a while, and finally companies are starting to get some traction … I think it's really building in momentum."
In addition to selling its GVAX assets, BioSante is also undergoing a reverse merger with ANI Pharmaceuticals Inc. in which the two companies will merge in an all- stock transaction, with BioSante, to be renamed ANI Pharmaceuticals Inc., as the surviving company. The transaction was announced in October 2012.
Code: E031325



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