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GEN News Highlights : Nov 17, 2010

Cold Genesys Buys BioSante’s Oncolytic Virus Technology

BioSante took a 19.9% stake in Cold Genesys and will get milestones and royalties.

BioSante Pharmaceuticals granted Cold Genesys exclusive, worldwide rights to its oncolytic virus technology in exchange for a 19.9% ownership position in the firm and $95,000 in cash. The deal also covers Phase I CG0070, a replication-competent adenovirus that is being investigated for treatment of superficial bladder cancer. BioSante is also eligible to receive future milestone and royalty payments.

BioSante acquired the oncolytic virus technology through its $38 million all-stock merger with Cell Genesys in 2009. It uses adenoviruses that are engineered to selectively replicate in targeted cancer cells producing large amounts of oncolytic virus until the cancer cell can no longer contain the virus and bursts.

“CG0070 has demonstrated that tumor cell destruction may be achieved through direct adenovirus-mediated oncolysis and GM-CSF induced antitumor cell immune activation,” states Paul A. DeRidder, M.D., urologist and COO of Cold Genesys. “Given the significant toxicity and limited efficacy of current treatment options, additional therapies for superficial and invasive bladder cancer are needed in order to increase bladder preservation and improve long-term outcomes.”

Based in Newport Beach, CA, Cold Genesys is a privately funded, early-stage company. It is developing anticancer therapies with bladder cancer as its main focus.

Since its purchase of Cell Genesys BioSante has primarily concentrated on developing its lead investigation candidate, LibiGel. It is in a Phase III trial as a treatment for female sexual dysfunction. In June the firm said that it would pocket about $14.2 million through a registered direct offering to progress this transdermal testosterone gel. BioSante expects to submit an NDA in 2011.

BioSante also gained a slew of cancer vaccines in development from Cell Genesys, called GVAX vaccines, which are different from the oncolytic virus vaccines. The GVAX vaccines use cell lines that are genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immunostimulant. The cells then are irradiated to prevent further cell division, but the cells remain metabolically active.

Currently, GVAX cancer vaccines are in various Phase I and Phase II studies. Trials include breast, colorectal, pancreatic, and prostate cancers as well as leukemia, multiple myeloma, and melanoma. Initial Phase III trials in prostate cancer were stopped in 2008, and Phase II studies are now being conducted under physician/investigator sponsored-INDs in pancreatic cancer, leukemia, and breast cancer.

In August 2008, Cell Genesys reported more deaths among those treated with GVAX in a Phase III prostate cancer study. It was comparing GVAX to Taxotere plus prednisone. The company became a ripe acquisition target, losing almost 90% of its value after these findings were reported.