REDWOOD CITY, Calif.—OncoMed Pharmaceuticals stands to gain more than $1 billion from a worldwide strategic alliance it recently struck with GlaxoSmithKline. Under the deal, the two companies will discover, develop and market novel antibody therapeutics to target cancer stem cells that are believed to play a key role in the establishment, metastasis and recurrence of cancer. The alliance will be conducted through GSK's Center of Excellence for External Drug Discovery (CEEDD).
OncoMed is set to receive an initial payment of cash combined with an equity investment, though the amounts have not been disclosed. However, the companies have revealed that OncoMed is eligible to earn milestone payments up to $1.4 billion from GSK based on the achievement of specified discovery, development, regulatory and commercial milestones. Furthermore, OncoMed will receive double-digit royalties on all collaboration product sales, and GSK will have an option to invest in a future initial public offering by OncoMed.
The alliance leverages OncoMed's expertise in the discovery and development of cancer stem cell antibody therapeutics and provides GSK with an option to license four product candidates directed at multiple cancer stem cell targets from OncoMed's broad library of monoclonal antibodies.
The first product candidate has already been identified: OncoMed's lead antibody product candidate, OMP-21M18, a monoclonal antibody that is scheduled to enter the clinic this year. But OncoMed reportedly has established a diverse pipeline of monoclonal antibodies to target multiple pathways important in the activity of cancer stem cells, and OncoMed will use its proprietary in vivo xenograft cancer stem cell models to identify monoclonal antibodies in a specific, undisclosed cancer stem cell pathway for GSK.
"We will work with OncoMed at all stages of the collaboration so we will be able to help select which molecules progress to proof of concept studies," says Pauline Page, director of science communications for GSK. "Once the PoC studies are completed, a final decision to in-license or not will be made."
At that point, GSK would assume responsibility for funding of further clinical development and commercialization on a worldwide basis, though OncoMed retains the option to participate in development and commercialization of OMP-21M18 on pre-agreed terms.
"We believe that targeting cancer stem cells has the potential to change the paradigm of how oncology patients are treated and we are very excited to be working with OncoMed to develop novel and innovative medicines in this regard," said Dr. Hugh Cowley, senior vice president and head of the CEEDD, in a news release announcing the deal.
Page adds that GSK is already accelerating its oncology research to quickly grow a franchise in the area of cancer stem cell research.
Aside from the boost in reputation and validation of its expertise in the area, Paul J. Hastings, president and CEO of OncoMed, sees a potential boost to his company's product line in the future. "[With this alliance] we gain access to significant non-dilutive financing to support the development of our novel cancer therapeutics, which we believe have the potential to significantly impact the outcome of cancer treatment."
The whole concept of cancer stem cells is based on the hypothesis that tumors are composed of heterogeneous cell types and that cancer growth and metastasis are driven by a sub-population of cells within the tumor, Hastings notes. The tumorigenic cells that have been dubbed "cancer stem cells" are so named because they exhibit properties reminiscent of the normal stem cells in adults that replenish various tissues.
Cancer stem cells differ from normal stem cells, though, because they have accumulated oncogenic mutations that result in the loss of normal limitations on growth. It is the belief of OncoMed and GSK that these differences can be exploited to develop therapies that selectively target tumor initiating cells and not normal stem cells.
OncoMed is set to receive an initial payment of cash combined with an equity investment, though the amounts have not been disclosed. However, the companies have revealed that OncoMed is eligible to earn milestone payments up to $1.4 billion from GSK based on the achievement of specified discovery, development, regulatory and commercial milestones. Furthermore, OncoMed will receive double-digit royalties on all collaboration product sales, and GSK will have an option to invest in a future initial public offering by OncoMed.
The alliance leverages OncoMed's expertise in the discovery and development of cancer stem cell antibody therapeutics and provides GSK with an option to license four product candidates directed at multiple cancer stem cell targets from OncoMed's broad library of monoclonal antibodies.
The first product candidate has already been identified: OncoMed's lead antibody product candidate, OMP-21M18, a monoclonal antibody that is scheduled to enter the clinic this year. But OncoMed reportedly has established a diverse pipeline of monoclonal antibodies to target multiple pathways important in the activity of cancer stem cells, and OncoMed will use its proprietary in vivo xenograft cancer stem cell models to identify monoclonal antibodies in a specific, undisclosed cancer stem cell pathway for GSK.
"We will work with OncoMed at all stages of the collaboration so we will be able to help select which molecules progress to proof of concept studies," says Pauline Page, director of science communications for GSK. "Once the PoC studies are completed, a final decision to in-license or not will be made."
At that point, GSK would assume responsibility for funding of further clinical development and commercialization on a worldwide basis, though OncoMed retains the option to participate in development and commercialization of OMP-21M18 on pre-agreed terms.
"We believe that targeting cancer stem cells has the potential to change the paradigm of how oncology patients are treated and we are very excited to be working with OncoMed to develop novel and innovative medicines in this regard," said Dr. Hugh Cowley, senior vice president and head of the CEEDD, in a news release announcing the deal.
Page adds that GSK is already accelerating its oncology research to quickly grow a franchise in the area of cancer stem cell research.
Aside from the boost in reputation and validation of its expertise in the area, Paul J. Hastings, president and CEO of OncoMed, sees a potential boost to his company's product line in the future. "[With this alliance] we gain access to significant non-dilutive financing to support the development of our novel cancer therapeutics, which we believe have the potential to significantly impact the outcome of cancer treatment."
The whole concept of cancer stem cells is based on the hypothesis that tumors are composed of heterogeneous cell types and that cancer growth and metastasis are driven by a sub-population of cells within the tumor, Hastings notes. The tumorigenic cells that have been dubbed "cancer stem cells" are so named because they exhibit properties reminiscent of the normal stem cells in adults that replenish various tissues.
Cancer stem cells differ from normal stem cells, though, because they have accumulated oncogenic mutations that result in the loss of normal limitations on growth. It is the belief of OncoMed and GSK that these differences can be exploited to develop therapies that selectively target tumor initiating cells and not normal stem cells.
