Pharmaceutical firm Abraxis Bioscience last week said that it has exclusively licensed from the University of Southern California worldwide development and commercialization rights for diagnostic protein biomarkers related to colorectal cancer.
USC officials said that the licensing deal is one of the biggest the university has announced in terms of market potential since it established the Stevens Institute for Innovation earlier this year in an attempt to speed technology commercialization.
Under the terms of the agreement, Abraxis has licensed a portfolio of intellectual property based on research conducted by Heinz-Joseph Lenz, an associate professor of medicine at the Norris Cancer Center in USC’s Keck School of Medicine.
Lenz and colleagues have discovered and characterized a broad range of molecular biomarkers associated with outcomes from a number of chemotherapeutics used to treat gastrointestinal cancers, in particular colorectal cancer.
Specifically, Abraxis licensed US patent applications and patents that were filed between several years ago up to a few months ago, Toni Gray, senior licensing associate for the Stevens Institute, told BTW last week.
“This is a large portfolio of primarily patent applications related to all the major gastrointestinal [cancer] drugs,” Gray said. USC has also filed patent applications related to Lenz’s work as it relates to other indications, Gray said, but added that “GI, and in particular, colorectal cancer is [Lenz’s] primary focus,” and that the entire portfolio was licensed to Abraxis.
Abraxis hopes to combine the prognostic markers with specific chemotherapies as a way for clinicians to tailor therapy to the molecular profile of a patient while reducing toxicities associated with those treatments.
“We have been able to develop over the last 10 years genetic markers that predict [treatment] outcomes [for] Campto/5-FU, irinotecan, oxiloplatin, Erbitux, and Avastin,” Lenz told BTW last week. “These data [have] all [been] generated in retrospective clinical trials — so they’re small-scaled — but show that this market has significant promise. In order to commercialize these markers, they need to be tested prospectively,” which Abraxis intends to do.
Lenz added that the markers should enable clinicians to select patients with increased benefit from specific drugs, to develop optimized combination strategies, and to minimize the toxic effects of the drugs.
He also said that he is “pretty confident that the [markers] can have an impact on overall outcome of the patient population not only for GI cancer, but for other [malignancies], as well. They need to be validated and developed in the commercial setting, though, because I cannot do that.”
A ‘Big Deal’ for USC
Financial terms of the licensing deal were not disclosed. However, Gray said that the arrangement is the biggest USC has announced and one of the biggest overall in terms of its potential impact on society since the Stevens Institute opened for business earlier this year. Colorectal cancer is the third most commonly diagnosed cancer in both men and women in the US with a predicted 149,000 new cases this year, and one of the leading causes of cancer-related deaths with an estimated 55,000 fatalities in the US in 2006.
“We are not able to announce everything that we do, but it is definitely the largest one to be announced,” Gray said. “It’s a big deal because of the technology and its significance in potentially improving patients’ lives. The current model of treatment is one size fits all, but we all are learning that there are other genetic factors either in your system or in the tumor’s system that do not support this”
The Abraxis deal may also have opened other doors for USC in terms of return on research investment: Gray and Lenz both confirmed that at least one other company has already inquired about sub-licensing the biomarkers from Abraxis for further development for different indications.
Lenz said that, prior to the licensing agreement, he was not familiar with Abraxis — which, like USC, is located in Los Angeles — so it was a “big surprise” for him to discover the company’s interest in commercializing the biomarkers.
“It’s a really good match with the common goal of pushing personalized medicine into practice, because there is a lot of talk about it, but not too much action.”
“This is not a company that works in the same patient arena that I see as a GI oncologist,” Lenz said. “I don’t use compounds from them. So we hadn’t developed a relationship over the years. I would have expected that maybe [a company like] Genentech, ImClone, Sanofi, or Pfizer would have done this, but they didn’t.
“I can only think that these guys really want to make a difference, and have heavily invested in potential tailored chemotherapy in the future,” he added. “So I’m surprised and impressed that they would take this on. It’s a really good match with the common goal of pushing personalized medicine into practice, because there is a lot of talk about it, but not too much action.”
Lenz said that he anticipates continued collaboration with Abraxis on the development of personalized treatments based on the biomarkers. “Even though we don’t have an agreement in place or anything, I want to make sure this market gets developed,” he said. “I will certainly help them to do that because I don’t think that Abraxis has the same background that we have in this area.”
Testing a New Tech-Transfer Model
The deal is also important to USC from the standpoint of being an early success story for the newly established Stevens Institute, a relatively unique technology transfer model that draws upon almost all areas of expertise at the school, Gray said.
“USC has really recognized that innovation is a huge objective of the university in every way imaginable, from fostering innovation in every discipline at the university, to encouraging innovation among the students, to teaching entrepreneurs what they need to know,” she said. “It’s a university-wide mission.”
To that end, the Stevens Institute handles all tech-transfer deals for the university as would a traditional tech-transfer office, but also offers educational opportunities to students and faculty alike in areas such as IP law or entrepreneurship.
Furthermore, the school is reaching out to other departments besides the traditional biomedical and engineering units, such as fine arts, media, communications, music, and others. Gray said that about half of the university’s research disclosures are biomedical related, but that USC is “really doing a lot more outreach to other schools and departments where we or other universities have not done traditional outreach.”
Since Stevens opened its doors, so to speak, the tech-transfer office has approximately doubled disclosure rates. “One of the great things we fight in tech transfer is that a professor publishes research and then we don’t have the disclosure,” she said. “But by doubling our disclosure rate, we then increase our odds of finding the diamond in the rough.”