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CytoDyn Looks to Move UMMS-Developed DNA Flu Vaccines to Clinical Trials in 2008

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Immunology specialty firm CytoDyn last week said that it has received updated DNA-based H1 and H3 serotype influenza vaccines for the 2007 and 2008 flu season from the laboratory of Shan Lu at the University of Massachusetts Medical School.
 
CytoDyn said that it hopes to use the vaccines in clinical trials next year to evaluate the new DNA-based, “prime-boost” vaccination method, which was invented by Lu, and to which CytoDyn has obtained an exclusive license — a process that was facilitated by technology transfer firm UTEK.
 
CytoDyn, based in Santa Fe, NM, began its foray into the flu vaccine market in 2006 when it acquired Advanced Influenza Technologies, at the time a subsidiary of UTEK and holder of a license for the vaccine technology.
 
After assimilating the company and its technology, CytoDyn last year formed a dedicated product-development team to expedite development of the DNA vaccine to take advantage of a weak supply chain of traditional flu vaccine in recent years.
 
“We were cognizant of the fact that these nineteenth-century vaccines that everybody is still using leave much to be desired, and we’re reminded every year when there is a shortage,” Al Allen, CytoDyn’s CEO, told BTW last week. “There is so much more we can do today.”
 
Allen said that CytoDyn, which had already been playing in the immunology space, primarily in the area of HIV/AIDS, told UTEK it wanted to acquire a technology that would allow it to move quickly into the flu vaccine space.
 
“When they found this technology, it didn’t look like what it was at first,” Allen said. “Everybody and their brother is working in this field and using genetic engineering to produce a better vaccine. We’re a small company, and needed something unique and with a definite product advantage in order to compete with companies like Pfizer.”
 
But after several publications by Lu and colleagues demonstrated the potential robustness of the DNA-based vaccine, CytoDyn thought it might have a winning technology platform on its hands.
 
“It turns out that this does allow us to compete because of the way UMMS structured [its] intellectual property,” Allen said. “Once we got interested, UTEK had to go back and negotiate with the university, and we wound up with a fairly large patent portfolio.” 
 
That portfolio includes non-exclusive licenses from UMMS that allow freedom to operate regarding several general DNA-based vaccination technologies, as well as several exclusively licensed technologies for applications in influenza.
 
Specifically, CytoDyn has exclusively licensed US Patent Application No. 20060217338, entitled “Influenza nucleic acids, polypeptides, and uses thereof;” and non-exclusively licensed US Patent Nos. 5,643,578 and 6,841,381, and US Patent Application No. 20040208851.
 
The company has also taken non-exclusive licenses to a number of related European, Canadian, and Japanese patents in the area of DNA-based influenza vaccines.
 
Not Your Father’s Flu Vaccine
 
DNA-based vaccines hold several perceived advantages over traditional vaccines, Allen said. The basic idea behind the approach is to genetically create an immune-activating antigen to inject into the subject, as opposed to an entire killed or attenuated virus.
 
Using genetic engineering, these antigens can be created relatively quickly in the laboratory when the virus changes — which influenza does frequently — as compared to the traditional method, which relies on isolating a new virus, purifying it, growing it in vitro (typically in a chicken embryo), inactivating it, and finally conducting toxicology testing.
 
“Even these old vaccines are OK for measles, mumps, rubella, and all these childhood diseases because you do it once,” Allen said. “But the flu virus is a new virus every year,” and this is not to mention the emerging threat of avian flu, he said.
 
In addition, DNA is more stable than whole or partial virus preparations, which means it can be more readily stored and shipped and therefore may avoid one reason for recent vaccine shortages.
 
“The trick is to get it to produce as robust an immune response as the virus itself would, and that’s where the problem has been, and is a big part of what we licensed exclusively from the UMMS,” Allen said. “It doesn’t do any good if you have all these other advantages and don’t end up protecting people. You want these advantages without paying a price in terms of efficacy. That technique is a major part of what we licensed.”
 

“Everybody and their brother is working in this field and using genetic engineering to produce a better vaccine. We’re a small company, and needed something unique and with a definite product advantage in order to compete with companies like Pfizer.”

Last week, CytoDyn announced that it received the flu vaccine serotypes – H1 and H3 – for the 2007 and 2008 flu season, which Lu and colleagues updated using their method in fewer than six weeks following a recommendation by the World Health Organization.
 
“There was a delay on the seasonal flu vaccine because the World Health Organization changed it,” Allen said. “It took Shan Lu six weeks to make that adjustment. Believe me, [other vaccine makers are] going to spend six months. We’re going to have another shortage next year until about December. “
 
Meanwhile, CytoDyn will be gearing up for clinical trials, which it hopes to have started by the 2007-2008 flu season. “That’s a forward-looking statement, and we’d have to have a lot of things not go wrong,” Allen said. “So far they haven’t. And then we’re dependent on how fast the [US Food and Drug Administration] will let us move, which we think they will probably be pretty cooperative about considering the problem.”
 
In January, CytoDyn also announced that Lu had joined the company’s scientific advisory board. Allen said that CytoDyn will have more opportunities to work with Lu and other UMMS researchers on related vaccination technologies.
 
“There are potential improvements on any technology, and we have other things that are optioned, including but not limited to Dr. Lu’s,” Allen said. “There is also an area of mutual interest that we may get together on: At a time when natural selection has made [HIV viruses] in millions of patients multidrug-resistant, what he’s doing and what we’re doing could merge there.”
 
UTEK Brokers Another Deal
 
The UMMS agreement is the second deal CytoDyn has consummated with UTEK. In February, CytoDyn acquired Advanced Genetic Technologies, a wholly owned subsidiary of UTEK, in a stock transaction.
 
That deal gave CytoDyn access to exclusive worldwide licenses for monoclonal antibodies TS1-18 and TS1-22, and non-exclusive rights to bacterial plasmid 8630, which were developed by Timothy Springer at Harvard Medical School’s CBR Institute for Biomedical Research.
 
CytoDyn said that it intends to use the antibodies for targeted immune therapy for HIV/AIDS as a potential solution to help address the problem of multidrug-resistant strains of HIV. The company also said it also envisions the bacterial plasmid as a potential diagnostic and screening tool for HIV/AIDS immunotherapies.
 
In both cases, Allen said, UTEK approached CytoDyn about the available technologies.
 
“We thought the deals made a lot of sense,” Allen said. “First of all, they know better than we could or anybody could what is available. It’s easy enough to go to different [tech-transfer] sites and start culling through [available technologies], but that’s time-consuming, and for a small company this is especially an issue. And when it comes to negotiating the terms, it’s really great, because they’re very knowledgeable.”

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