Not your usual CRO arrangement
February 2013
by Amy Swinderman  |  Email the author


HYDERABAD, India—It's not uncommon for U.S.-based drug developers to seek the services of a contract research service provider abroad, but it is novel for a company to align itself with a service provider that contributes intellectual property of its own to a drug discovery target. That's the unique drug discovery model put in place last month by Onconova Therapeutics, a U.S.-based biopharmaceutical company focused on the development of novel small molecules for oncology, and Indian contract research organization (CRO) GVK Biosciences.  
On Jan. 9, the companies announced that they have entered into a novel joint endeavor to develop new cancer drugs. The partnership will be based in the United States and will align research priorities and technological expertise from both companies to facilitate moving certain Onconova oncology assets from early discovery to the clinical development stage. Dr. E. Premkumar Reddy, the scientific founder and director of Onconova and a world-renowned molecular oncologist, will oversee the biology and biomarker aspects of the partnership. Onconova will provide two discovery targets with early chemical equity, while GVK BIO will use its multidisciplinary discovery platform to advance these programs through lead optimization and Investigational New Drug (IND) candidate selection.
GVK will gain an increasing share of the programs as they advance, up to a 50/50 split based on achievement of milestones and funding brought into the joint partnership. Onconova retains the rights to buy back the programs. Financial terms of the partnership were not released.  
"We have used CROs for some of our clinical trials, but not in this capacity," says Ben Hoffman, director of public and investor relations for Onconova. "This is a unique agreement in that GVK will openly serve as a partner that is helping us to develop our assets. They were highly motivated to help us move these projects forward."  
Founded in 1998 as a chemistry platform company, Onconova has an internally developed pipeline of mostly small-molecule agents based on a portfolio of nearly 150 different chemical phenotypes. The company is now focused on pursuing novel pathways to specific types of cancer, improving drug efficacy and overcoming drug resistance and the burden of chemotherapy toxicity.  
Onconova's most advanced product, rigosertib, is being tested in a Phase III pivotal trial under a Special Protocol Assessment from the U.S. Food and Drug Administration for myelodysplastic syndromes (MDS), a type of blood cancer. Onconova is developing rigosertib in partnership with Baxter Intl. for Europe and SymBio Pharmaceuticals for Japan and Korea, and retains commercial and development rights in the rest of the world.  
Rigosertib has been granted orphan drug status for MDS in both the United States and Europe. A New Drug Application submission for rigosertib's initial indication for MDS is projected for 2014. Onconova is also developing rigosertib as a treatment for metastatic pancreatic cancer.  The drug is currently being tested in a Phase III trial (with a planned interim analysis) for this indication.  
In addition, Onconova is targeting unmet needs in blood cancers and solid tumors to ensure rapid approval and first-to-market advantage for its advanced products. GVK BIO works with more than 200 pharmaceutical and biotech companies across multiple service offerings, has a scientific pool of more than 2000 scientists and has an IP-generating capability that has delivered INDs to other clients. 
"The demands for integrated and outcome-based research deals are increasing in the service business," said Manni Kantipudi, CEO of GVK, in a press release announcing the partnership. "This announcement shows GVK BIO's commitment to new and innovative models for drug discovery with partners. Onconova is a leading oncology company, and GVK BIO is happy to partner with them."
Code: E021327

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