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HIV Pioneer Profectus, Planning New Hires, Set to Move Into New Vaccine-Development Center

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A Baltimore vaccine developer that takes its name from the Latin phrase for "to advance or improve" will be doing just that to its vaccine innovation center near Tarrytown, NY.

During the process, Profectus BioSciences’ center will roughly triple in size as part of an expansion fueled by its acquisition of technologies from Wyeth and the University of Maryland School of Medicine's Institute of Human Virology, as well as plans to launch six Phase 1 studies into the safety and effectiveness of its HIV prime-boost therapeutic vaccine.

Profectus is set to move in December into 20,000 square feet at The Landmark at Eastview, a 275-acre office/life-sciences campus that straddles the suburban New York towns of Greenburgh and Mount Peasant. The new space, formerly occupied by Regeneron Pharmaceuticals, will allow Profectus to accommodate more than 20 new researchers it plans to hire over the next two years, in addition to the 13 employees now based in temporary space at Landmark at Eastview.

In return for the promised jobs, the Empire State Development Corp., New York state's economic-development agency, has awarded Profectus a $105,000 grant. Profectus may also pursue additional local economic incentives, Shawn Patrick O’Brien, the company's president and CEO, told BioRegion News this week.

The deal does not affect Profectus' headquarters, which will remain in Baltimore at 6411 Beckley St. Baltimore is also home to IHV, whose founders — William Blattner, former chief of viral epidemiology at the National Cancer Institute; Robert Redfield, former chief of retroviral research at the Walter Reed Army Medical Center; and Robert Gallo, who as an NCI researcher co-discovered the human immunodeficiency virus's role in causing AIDS — formed Profectus in 2003, in part as a vehicle to develop and commercialize select technologies developed at the institute.

Profectus is the second life-sciences company to announce job-creation plans in New York's suburb of Westchester County. About seven miles south of Landmark at Eastview, which is owned by BioMed Realty Trust, OSI Pharmaceuticals plans to consolidate in Greenburgh its Melville, NY, headquarters, a second Long Island site in Farmingdale, NY, and facilities in Boulder, Colo., and Cedar Knolls, NJ [BRN, July 17].

Last week Profectus followed up the ESD's announcement of its expansion with additional news: The company completed a $5 million Series C venture financing round led by Cross Atlantic Capital Partners, and entered into a $1 million equipment leasing line of credit with Fountain Partners of San Francisco, toward the purchase of laboratory equipment for the Tarrytown facility.

BRN recently interviewed O'Brien about Profectus' upcoming expansion near Tarrytown, and the vaccine technologies being researched by the company. Following is an edited transcript of that interview.

First, may I check the status of the expansion announced for Tarrytown?

Right now, we've moved 13 people into a temporary facility of 7,700 square feet, and we're re-doing some previous Regeneron space, and moving into that in December.

The state Empire State Development Corp. has announced it is offering your company a $105,000 grant tied to job-creation goals. What additional economic incentives will the company receive? Anything from Westchester County or the town of Greenburgh?

They're still being worked out, but there are some other areas of opportunity for us, from the regional aspect.

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What attracted Profectus to the New York metro area in general, and to Landmark at Eastview in particular?

The rationale is, we did a deal with Wyeth, and did a spin-out of their vaccine research group that was leaving the [fields of] HIV and HCV discovery and research on creating therapeutic and preventive vaccines for HIV. And when we did that spin-out we also secured a $21.6 million government grant that was remaining of the total $80 million grant to produce vaccine candidates for clinical trial. So as part of that spin-out, we were picking out key employees that had the knowledge and ability to drive the plasmid DNA and the recombinant VSV delivery systems forward.

So it was key, in developing the right kind of staff, that we had to look at: Would we locate in New Jersey? Relocate them down in Maryland? Or in New York? We investigated the areas, and the Tarrytown Landmark [at Eastview] facility seemed to be an ideal location for the talent base.

As we go forward, the facility — being able to find a place where we could get on and do our work, and build a space that's going to accommodate us in the longer term — was part of this equation. The incentives that we're getting out of New York compared to the other states were part of the other considerations that we looked at, [as were] access to a location that worked for the previous Wyeth employees and has access to the talent in the area that that proximity gives us.

Do I understand correctly, then, that you looked in Maryland and New Jersey?

We did. In New Jersey, we looked at putting the facility in a place, and in Maryland, we looked to bring the facility down here [to Profectus' headquarters].

Had there been any thought of locating within Wyeth space?

We did talk to Wyeth about that. But our deal was being consummated ahead of the Pfizer deal at the time, and it just wasn't going to work logistically. We tried to investigate that in the Pearl River (NY) location

How does the expansion play into Profectus' clinical trial plans? Does that move or relocate the clinical trials to the New York area?

Relative to clinical trials, the outcome of the research we're doing under the HIV government contracts is to produce clinical candidates, and the data was presented to a division of NIH, (the National Institute of Allergy and Infectious Diseases), and the clinical trials group, the HIV vaccine trial network or HVTN, and the AIDS clinical trial group or ACTG. And upon looking at our data, they said it was the robust data so far in these Rhesus Macaque animal studies, and agreed to support the funding and conducting of our clinical trial program.

The clinical trials are going to be done on a nationwide basis, through an agreement through those two trial networks, the ACTG for patients that have the disease, and the HVTN for healthy patients as a preventive. We have a therapeutic and a preventive strategy. The work of the clinical trials, John Eldridge is our chief scientific officer for the vaccine. He's leading the group up there in Tarrytown, NY, and is working with our government partner to design and drive the clinical trials and programs. But they will be all conducted by the government for us.

What's the timing in terms of launching this program?

We are working on the protocols now. We have one active [investigational new drug] and have two more in play. We expect to open the trial up just after Thanksgiving this year.

Profectus is now headquartered in Baltimore. How many employees are based there?

There are 14 employees down here.

How many of those employees will be affected by the expansion move into the Tarrytown facility?

No. We did a reduction here in our Maryland facility to focus more on the vaccine delivery and focus more on our small molecule program. The majority on staff here are either doing our small molecule program, which is our NF-kB program [the initials are short for 'nuclear factor kappa-light-chain-enhancer of activated B cells' — Ed.] for inflammation, and for the other part of their work, which is supporting the vaccine work that we're doing, with the Wyeth technology that we license, and also our vaccine; we license it from the Institute of Human Virology.

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We are the commercialization partner for Bob Gallo's Institute of Human Virology in Baltimore. Whatever technology comes out of that institute, we have right of basic first refusal to take it on, and see if there is any commercial viability in it. So some of the technology we're working on down here is that of the Institute of Human Virology.

What will happen, ultimately, to the Baltimore headquarters? Will that continue for the company?

As far as we see, we continue to have success in developing our small molecule program, and we continue to have success in securing external funding and grant funding. On July 22, we announced that we secured $5 million in series C fundraising to Cross Atlantic Capital Partners, to support the operation of the company. That pays for some of the NF-kB work, in addition to the cost of running the business over the next year.

How much in funding has the company raised?

That brings the total to $19 million in equity funding, and obviously more than that in non-dilutive funding. The portfolio has attracted over $100 million in non-dilutive funding in Wyeth's and in our hands.

We plan to raise another round of funding in the new year, first quarter, of Series D — around $15 million to $20 million. That would carry the company totally through 2012, which will allow us to deliver phase two data on HCV and HIV. We complement that with a non-dilutive funding sources, the government grants and the [$15 million Bill and Melinda] Gates [Foundation] grant [to IHV], and things of that nature, that allow significant amount of what I'd say are us to move ahead.

Please talk a little more about the government funding, specifically the more than $20 million of remaining non-dilutive funding awarded to Wyeth by DIAIDS.

Wyeth has two government contracts — one to produce a plasmid DNA vaccine for HIV, and one to produce recombinant VSV, and the two combined together in both preventive and therapeutic vaccines. Those contracts were worth $80 million originally. And when the two contracts were novated to us, we took over the delivery of those contracts. There was $21.6 million remaining in research funding and government work. We are working with the government actually to expand that, because they're interested in developing it beyond the current scope of the contracts.

In addition, we've secured a commitment from the government to actually fund and deliver the clinical trials, the six phase 1 clinical trials, using those clinical constructs that are a result of that research. The other areas that we are working on are in HCV, HPV, and HSV. In addition, our other technology in HIV from the Institute in Human Virology, so we have our full-length single chain program. We're working on 14 different government proposals. They're either submitted, or pending to be submitted to [secure contracts toward] the delivery of the research in those therapeutic areas.

On the HIV virus, what sub-segment of people with the virus does your research focus on?

What we're looking at in the therapeutic areas is take the infected patients that are early in their infection, and treat them with the therapeutic vaccines prior to getting standard-of-care therapy that's available today ... In the prevention market, it's looking at using healthy patients to determine the safety and efficacy of the compound. Obviously, if it's successful, it would be delivered into high-risk populations prior to the normal populations for priority purposes.

What thought has the company given to expanding in Tarrytown some time beyond the two years of the trials?

As we continue to be successful in developing the compounds, then expansion will continue with that. The amount of work and resources to deliver clinical development versus pure research changes dramatically. So we will continue to grow the business with the success of the programs, and our success to attract funding, whether it be equity or non-dilutive sources, to expand the programs beyond HIV and HPV. We're working and pursuing hepatitis-B and HPV and HSV, and we're also looking at some other areas to expand into.

Our technology seems to be very comprehensive in its delivery of the antigen expression, and so we believe we can leverage it into many serious chronic viral infections and infectious diseases. And malaria is another area that we're working in.

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