Lipid Sciences, a Pleasanton, Calif.-based drug-development company, has licensed a cell-based assay technology from The Children’s Hospital of Philadelphia to help it validate cardiovascular disease treatments as it readies them for regulatory approval, the company said recently.
The non-exclusive deal is year-to-year, which Lipid Sciences says is an increasingly used deal model that gives technology-transfer offices better control over how its technology plays in a market, which could in turn enable it to seek new suitors if an original application fizzles.
Tech-transfer offices commonly license technologies non-exclusively to companies, but year-to-year deals are less common, according to Vikas Sharma, licensing associate at CHOP’s TTO. Both techniques are an ideal way for university TTOs to monitor the progress of a licensed technology to ensure that it is being commercialized in a way or at a pace that suits the school and the inventor.
Sharma said that CHOP typically requires a company to provide an initial development plan for a technology and to follow up with yearly progress reports.
“We want to see that something is done with the technology,” Sharma told BTW last week. “Someone might just take a license and not do anything with it, and that hinders drug development. The advantage of this is we can revisit the situation.
“There are obviously provisions to renew the license, but if we feel they’re not doing enough with the technology, we should be in a position to terminate it,” he added.
This is something that companies often try to fight, according to Sharma and Lipid Sciences President and CEO Lewis Meyer. However, from Lipid Sciences’ perspective, “if you look at our financial exposure under this license agreement versus our financial exposure if CHOP were to want to do this for us, it’s not all that different,” Meyer said. “There is a little extra work in bringing the tech to Lipid Sciences, but we then have the flexibility to do an unlimited number of assays in a [given] period of time.”
Furthermore, Meyer said he suspects that the renewable one-year agreement gives CHOP the flexibility to eventually decide if it would like to provide a commercial service to Lipid Sciences based on the assay.
“And that’s fine with us, too,” Meyer said. “Developing assays is not our business – it’s developing these processes that improve the functionality of HDL. And there are a lot of benefits to having [CHOP] do it and not us.”
Meyer also indicated that CHOP would not be entitled to any royalties stemming from future Lipid Sciences products, so the deal does not represent a huge financial windfall for CHOP, relatively speaking.
Science of Lipids
The licensing agreement between Lipid Sciences and CHOP is for intellectual property related to a cellular assay that determines the flux of cholesterol molecules between cells and serum lipoproteins such as high-density lipoprotein, or HDL.
Someone might just take a license and not do anything with it, and that hinders drug development. The advantage of this is we can revisit the situation.”
Developed by George Rothblat, a professor of pediatrics at the Joseph Stokes, Jr., Research Institute at CHOP, the technology is described in US Patent No. 7,029,863, entitled “Cell culture system for determining the cholesterol efflux potential for serum.”
Specifically, the IP covers a pair of cell-based assays for cholesterol efflux. The first assay measures scavenger receptor class B type I-mediated cholesterol efflux and the second measures ATP binding cassette protein 1-mediated cholesterol efflux.
According to the patent’s abstract, researchers use the assays in parallel to test human and animal sera for their potential to stimulate efflux mediated by either of the two receptors.
Lipid Sciences is developing a pair of therapies for cardiovascular disease – in particular, acute coronary syndrome brought on by the development of arterial cholesterol deposits. Both therapies are based on the fact that HDL is involved in a process known as reverse cholesterol transport, in which it targets, binds, and removes coronary artery plaques.
Cholesterol bound to HDL is popularly referred to as “good” cholesterol, as opposed to low-density lipoprotein, or LDL, which is responsible for plaque development.
Lipid Sciences’ first therapy is called HDL-selective delipidation, in which a liter of plasma is taken from a patient with coronary disease, treated to increase the amount of free HDL, and replaced. The second therapy is known as HDL-mimetic peptides, which are synthetic HDL molecules that are infused into the plasma instead of natural HDL as part of the treatment process.
Meyer told BTW last week that Rothblat’s assay technology is a way for Lipid Sciences to “prove that we’re really doing what we say we can do” by demonstrating how effectively processed plasma can remove cholesterol from cells, as well as “whether or not you’re effluxing it via the metabolic pathway that you’d like to activate to be specific for these plaques in coronary arteries.”
Rothblat developed the assay technology based on previous work he did on cholesterol transport and as part of research sponsored by Lipid Sciences. Rothblat had been using his cell-based assay in his laboratory to validate Lipid Sciences’ plasma-treatment technique. Lipid Sciences recently presented this validation data at March’s Cardiovascular Revascularization Therapies conference in Washington, DC.