By Brady Huggett
Isis Pharmaceuticals Inc. signed a drug development collaboration agreement with young OncoGenex to co-develop OGX-011, a compound based on OncoGenex¿s target, clusterin.
OGX-011 is a combination of Isis¿ second-generation antisense chemistry and OncoGenex¿s inhibitor to the clusterin target. After working together on preclinical studies for about 18 months, the companies decided to make it official and signed the deal.
¿The initial discovery of the target came from the Prostate Centre at Vancouver Hospital and Health Sciences Centre,¿ said Scott Cormack, president and CEO of OncoGenex. ¿The hospital [conducted] the preclinical work and then [OncoGenex] acquired the compound.¿ Following that, Isis and OncoGenex repeated some of the preclinical studies to ensure they were seeing the results they wanted to see.
Clusterin acts as a cell survival protein, although it also is a gene, Cormack said. He explained how OGX-011 works:
¿When cancers are targeted with anything that induces apoptosis, there is a cell death signal that is induced,¿ he said. ¿In response to that, clusterin is up-regulated. What we are doing is taking away that survival signal, so it allows for a more complete death.¿ OGX-011 inhibits the cell survival signal clusterin and, in theory, allows apoptosis-inducing anticancer agents to better do their job.¿
The companies hope to file an investigational new drug application for OGX-011 next year, said Lynne Parshall, executive vice president at Isis. In the collaboration, Isis, of Carlsbad, Calif., will have responsibility for conducting preclinical toxicology and pharmacokinetic studies and will manufacture OGX-011 for both preclinical and Phase I/II studies. OncoGenex will perform Phase I/II trials of OGX-011 as a single agent and in combination with docetaxel in men with localized and hormone-refractory prostate cancer. Financial details were not disclosed, although Parshall said the companies were ¿sharing activities to support the drug,¿ as well as ¿sharing economics.¿
Aventis Pharma Inc., of Bridgewater, N.J., brought into the mix through its long-standing relationship with OncoGenex co-founder and Chief Scientific Officer Martin Gleave, is providing financial support for the compound and also will supply neo-adjuvant hormone therapy for the study protocol.
When and if the compound makes it into humans, it will join Isis¿ 12 other products in development, including ISIS 3521, in Phase III trials for non-small-cell lung cancer, and ISIS 2302, about to begin a Phase III trial in Crohn¿s disease. The company has five products in Phase II trials. But for OncoGenex, OGX-011 is a priority.
OncoGenex, of Vancouver, British Columbia, is a small, private company founded in May 2000. It has three employees, and the deal with Isis stands as its biggest news to date.
¿For Isis and Aventis to take interest in a company at this stage is pretty rare,¿ Cormack said. ¿Especially in a co-development deal like this. We have a pipeline of products that we are looking to move forward ¿ one of our main strategies is to obtain technologies ¿ but this is our lead product.¿
Isis cares little about the size or age of OncoGenex; it¿s about the compound, after all.
¿The target, clusterin, is a very attractive target, we think, for anticancer therapy,¿ Parshall said.
Isis¿ stock (NASDAQ:ISIP) rose $1.06 Monday to close at $26.65.