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AstraZeneca is First Participant in Cancer Research UK’s Clinical Partnering Program

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Cancer Research Technology, the development and commercialization arm for research charity Cancer Research UK, said this week that it will coordinate and conduct clinical trials for a potential anti-cancer compound developed by AstraZeneca.
 
The compound, a tyrosine kinase inhibitor, is the first drug candidate to enter CRT’s Clinical Development Partnerships program, which aims to further develop promising anti-cancer agents that have been “deprioritized” by pharmaceutical and biotech companies, a CRT official said this week.
 
The announcement also comes a week after London-based CRT announced the establishment of a new drug-discovery laboratory in Cambridge to further support its cancer-related technology-transfer and drug-development activities.
 
CRT is a wholly owned subsidiary of non-profit CR-UK, which bills itself as the largest independent cancer research organization in the world, and which has an annual research budget of more than £315 million ($620 million) to support nearly 500 research groups throughout the UK.
 
CR-UK and CRT differ from most charitable organizations in that they have developed internal drug-development capabilities rivaling many pharmaceutical and biotech companies. The CDP program is one of several initiatives within the organizations aimed at obtaining and developing cancer research programs from industrial and academic groups around the world, particularly in the UK, the US, and, more recently, Australia.
 
One of CRT’s newest programs, CDP was established in 2006 and provides a unique opportunity for drug-discovery companies to partner on projects that they have neither the time nor money to pursue.
 
“In terms of charity-funded organizations, I think this is unique,” Campbell Wilson, director of strategic planning and business development for oncology and infection discovery at AstraZeneca, told BTW this week.
 
Under the terms of the agreement, CR-UK’s drug-development office will conduct clinical trials for the tyrosine kinase inhibitor, called AZD0424, at no cost to AstraZeneca, which will retain the option to continue developing and eventually marketing the drug at any time.
 
In exchange, CR-UK will receive a share of any revenues. Potential downstream royalties have not been disclosed, although an AstraZeneca spokesperson said that “the negotiations are consistent with those we would work out with any other institution we would collaborate with.”
 
Wilson added that, in terms of specific timelines or milestones, “as with any other agreement, there are certain conditions and terms associated with the deal.”
 
He also said that many biotech companies offer a clinical development arrangement to large pharmaceutical companies, but those “will often fall short of putting anything in writing” in terms of the drug candidate’s progress. “There is nothing as structured as this,” he added.
 
“During our normal course of events in the US, in a situation like this, we would be funding this and directing the development,” Wilson continued. “In this case, CR-UK is directing the program and funding it.
 
“There is a shared risk,” he added. “If we were doing all the spending, they would not have the potential for as big of a reward. The important thing here is that we shared the profile of this data, and their scientists could see a clear path to market.”
 
Keith Blundy, chief executive of Cancer Research Technology, said the CDP’s mission is to take over promising drug candidates that have been “deprioritized, not because it’s technically bad, it’s just that they’ve got better stuff to do.”
 

“The important thing here is that we shared the profile of this data, and their scientists could see a clear path to market.”

Blundy told BTW that companies can and do work with CRT on clinical trials in many other ways. “They may say, ‘We’ve got this agent. We want to trial it anyway. Can we do it with you?’” Blundy said. “They could even pay for it if they wanted to. Or, they could approach an academic or clinician that we fund and enter some kind of collaboration.”
 
Furthermore, he added, clinical trials are “only one aspect” of what CRT does, as the organization has forged multiple discovery partnerships, pre-clinical research agreements, and licensing deals with companies and academic institutions.
 
“The difference with what we’re offering here is that they wouldn’t do this if we didn’t help them,” Blundy said. “The reason they are ready to put any effort into it at all is that we’re basically paying for it and putting up the resources. So it’s at our risk. We have to believe technically and clinically that this is worth doing, and we have to be fairly assured that they wouldn’t do this anyway.”
 
Blundy also said that CRT can offer a potential partner the opportunity to take a molecule back under its wing if CR-UK’s researchers are able to coax more promising data out of it. “We’re not looking to hold onto it,” Blundy said. “They can take it and have all the benefits … for a revenue share of some kind, which hasn’t been disclosed.”
 
In terms of the AZD0424 molecule, neither Blundy nor Wilson would reveal exactly what it was about the compound that made it less of a priority at AstraZeneca and a promising target for further development by CR-UK.
 
“We haven’t revealed more than that it’s a TK inhibitor, so I can only say that we think this molecule can be competitive for the target against which it is directed,” Blundy said. “Obviously we only do things we think technically or clinically could have benefit.”
 
The CDP program is funded entirely through the CR-UK charitable fund, which the organization raises through public donation campaigns, Blundy said. Currently the fund is over £400 million, and CR-UK replenishes this “de novo every year through legacies, fundraising events, people putting money in tins; all kinds of ways.
 
“We choose how to spend that best to help cancer patients,” he added. “And we believe that a limited amount of money in this area is a good thing, because we’re moving more drugs along that otherwise wouldn’t have progressed.”
 
If the drug happens to reach the market, whatever pre-negotiated financial share retained by CRT will be funneled back into CR-UK’s cancer research programs.
 
The clinical trials will be conducted at various undisclosed hospitals and academic medical centers throughout the UK. This is another benefit to potential pharma partners: CR-UK already has an extensive network in place for identifying ideal research partners or clinical trial sites.
 
“There are a large number of centers that we fund, and clinicians that we fund,” Blundy said. “When we take these proposals to our review committees, there are people there that say, ‘If we take this molecule on, I’d be interested in trialing it.’ And CR-UK will fund it through that network.”
 
The organization’s drug-development office currently employs about 140 people “who have done this in an industrial setting and are now doing it in an academic setting,” Blundy said. Added Wilson, “we know about the clinical development expertise that they have, so we knew the experience they would bring to the partnership.”
 
Cambridge Expansion
 
The CR-UK/CRT footprint has recently grown, as well. Last week CRT said that it had opened a drug-discovery lab in Cambridge to supplement its London research labs.
 
The new lab will employ about 25 medicinal chemists, biochemists, and biologists in a facility near the University of Cambridge and the CR-UK-funded Cambridge Research Institute. Blundy said that CRT hopes to have some 90 people working in the new lab by the end of the year. The organization has also recently established small research groups at CR-UK-funded facilities in Manchester and Glasgow.
 
CRT said that it plans to announce several partnering activities related to its newer laboratories in June at the Biotechnology Industry Organization annual meeting in San Diego.
 
The organization may also have some news regarding its foray into the US over the past two years. In 2006, it established a US subsidiary in Cambridge, Mass., to try and solicit partnerships with academic institutions and companies in the states interested in tapping into the drug-discovery and tech-transfer programs offered through CRT (see BTW, 5/21/2007).
 
The US subsidiary’s first partnership was an oncology-focused collaboration with Fox Chase Cancer Center to develop small-molecule inhibitors of an undisclosed kinase. Under the terms of that agreement, CRT will be responsible for commercializing the inhibitors and any associated intellectual property arising from the research. Any revenues generated following commercialization will be shared between CRT and Fox Chase.

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