Not your usual CRO arrangement

U.S.-based biopharma Onconova partners with Indian CRO GVK Biosciences on development of cancer drugs

Amy Swinderman
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HYDERABAD, India—It's not uncommon for U.S.-based drugdevelopers 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 thatcontributes intellectual property of its own to a drug discovery target. That'sthe unique drug discovery model put in place last month by OnconovaTherapeutics, a U.S.-based biopharmaceutical company focused on the developmentof novel small molecules for oncology, and Indian contract researchorganization (CRO) GVK Biosciences.
On Jan. 9, the companies announced that they have enteredinto a novel joint endeavor to develop new cancer drugs. The partnership willbe based in the United States and will align research priorities andtechnological expertise from both companies to facilitate moving certainOnconova oncology assets from early discovery to the clinical developmentstage. Dr. E. Premkumar Reddy, the scientific founder and director of Onconovaand a world-renowned molecular oncologist, will oversee the biology andbiomarker aspects of the partnership. Onconova will provide two discoverytargets with early chemical equity, while GVK BIO will use itsmultidisciplinary discovery platform to advance these programs through leadoptimization and Investigational New Drug (IND) candidate selection.
GVK will gain an increasing share of the programs as theyadvance, up to a 50/50 split based on achievement of milestones and fundingbrought into the joint partnership. Onconova retains the rights to buy back theprograms. Financial terms of the partnership were not released.
"We have used CROs for some of our clinical trials, but notin this capacity," says Ben Hoffman, director of public and investor relationsfor Onconova. "This is a unique agreement in that GVK will openly serve as apartner that is helping us to develop our assets. They were highly motivated tohelp us move these projects forward."
Founded in 1998 as a chemistry platform company, Onconovahas an internally developed pipeline of mostly small-molecule agents based on aportfolio of nearly 150 different chemical phenotypes. The company is nowfocused on pursuing novel pathways to specific types of cancer, improving drugefficacy and overcoming drug resistance and the burden of chemotherapytoxicity.
Onconova's most advanced product, rigosertib, is beingtested in a Phase III pivotal trial under a Special Protocol Assessment fromthe U.S. Food and Drug Administration for myelodysplastic syndromes (MDS), atype of blood cancer. Onconova is
developing rigosertib in partnership with Baxter Intl. forEurope and SymBio Pharmaceuticals for Japan and Korea, and retains commercial anddevelopment rights in the rest of the world.
Rigosertib has been granted orphan drug status for MDS inboth the United States and Europe. A New Drug Application submission forrigosertib's initial indication for MDS is projected for 2014. Onconova is alsodeveloping rigosertib as a treatment for metastatic pancreatic cancer.  The drug is currently being tested in aPhase III trial (with a planned interim analysis) for this indication.
In addition, Onconova is targeting unmet needs in bloodcancers and solid tumors to ensure rapid approval and first-to-market advantagefor its advanced products.
GVK BIO works with more than 200 pharmaceutical and biotechcompanies across multiple service offerings, has a scientific pool of more than2000 scientists and has an IP-generating capability that has delivered INDs toother clients. 
"The demands for integrated and outcome-based research dealsare increasing in the service business," said Manni Kantipudi, CEO of GVK, in apress release announcing the partnership. "This announcement shows GVK BIO'scommitment to new and innovative models for drug discovery with partners.Onconova is a leading oncology company, and GVK BIO is happy to partner withthem."

Amy Swinderman

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