BERKELEY, Calif.—Building on a previous agreement, AduroBioTech, Inc., a clinical-stage immunotherapy company, has acquired all GVAXassets from Lincolnshire, Ill.-based BioSante Pharmaceuticals Inc., includingintellectual property and cell lines. The acquisition covers all uses,including GVAX Pancreas and GVAX Prostate, which Aduro had licensed before, aswell as vaccines for multiple myeloma, breast and colon cancer and the rightsto an existing license agreement for GVAX Melanoma. Per the terms of theagreement, Aduro paid BioSante $1 million up front for the assets, with acommitment for additional milestone and royalty payments following thecommercialization of any GVAX products.
The previous agreement between BioSante and Aduro wasannounced in April 2011, when Aduro licensed BioSante's Pancreas Cancer Vaccineand Prostate Cancer Vaccine solely for use in combination with its ownproprietary Listeria-based vaccines.Though no specific financial terms were released, the agreement involvedmilestone and royalty payments for BioSante once combination cancer vaccinesthat used the company's vaccine technology were commercialized. Aduro also hadan option to additional cancer vaccine indications of BioSante's.
"Combinations are the future of immunotherapy, especiallyfor cancer," Dr. Thomas W. Dubensky Jr., chief scientific officer at Aduro,said in a press release. "In addition to our efforts, other researchers haveshown in early-phase pancreatic and prostate cancer clinical trials that thecombination of GVAX with the approved immune checkpoint inhibitor ipilimumabimproves patient outcomes. With the acquisition of GVAX, we have a uniqueopportunity to advance an entire portfolio of combination treatments."
The GVAX cancer vaccines utilize human cancer cell linesthat have been genetically modified to secrete granulocyte-macrophagecolony-stimulating factor, an immunostimulant. The cell lines are then irradiated,which prevents cell division, yet they stay metabolically active. A number ofstudies are underway for the products, and the pancreatic cancer, leukemia,myeloma, breast cancer and prostate cancer vaccines are all in the late humanclinical stage, with colorectal and melanoma in the early human clinical stage.BioSante has been granted U.S. Food and Drug Administration Orphan Drugdesignation for several vaccines, including GVAX Pancreas for the treatment ofpancreatic cancer, GVAX AML for the treatment of acute myeloid leukemia, GVAXCML for the treatment of chronic myeloid leukemia and GVAX Melanoma for thetreatment of melanoma.
Aduro is currently evaluating the sequential administrationof the GVAX Pancreas vaccine and its own Listeria-basedCRS-207 in metastatic pancreatic cancer patients. The company was veryinterested 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 Listeriamonocytogenes platform is one of three at Aduro, along with GVAX and cyclicdinucleotides (CDNs), which Aduro describes on its website as "small moleculessecreted by Listeria and otherintracellular pathogens that signal through STING (STimulator of INterferonGenes) and induce a potent immune response." The company's Listeria approach has several advantages, such as targetingdendritic cells, signaling the innate immune system through multiple pathwaysand an ability to be repeatedly administered. Aduro is also combining the CDNswith GVAX into a new vaccine known as STINGVAX, which has shown to be moreefficacious than GVAX alone in animal models.
According to Isaacs, the cancer vaccine market is one thatwill likely continue to see growth.
"I think some of the other therapies have really sort of hitthe wall, in terms of radiation and chemotherapy and surgery; you can onlyreally do so much. And I think a lot of the pathway-specific drugs are kind oflike whack-a-moles—you knock one out and the cancer cells figure out a way tomutate around it, and then you need another one for a different pathway," saysIsaacs. "So I think the whole concept of using the immune system to fightcancer—and to kind of keep cancer in check for all of us, in any case—but toactually fight it when it does occur, is a good one. It's been around for quitea while, and finally companies are starting to get some traction … I think it'sreally building in momentum."
In addition to selling its GVAX assets, BioSante isalso undergoing a reverse merger with ANI Pharmaceuticals Inc. in which thetwo companies will merge in an all-stock transaction, with BioSante, to berenamed ANI Pharmaceuticals Inc., as the surviving company. The transaction wasannounced in October 2012.