Frederick County Biotech Community

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IVGN announces Licensing deal with WARF

Posted by Jim H on May 8, 2008

According to their web site today, Invitrogen has signed an agreement with Wisconsin Alumni Research Foundation (WARF) for Human Embryonic Stem Cells.

According to the release:

Under the terms of the agreement, Invitrogen will have the right to work with karyotypically normal hESCs to develop novel research and drug discovery tools.

“Invitrogen’s goal is the development of research tools that enhance the ability of scientists to work with embryonic stem cells and to enhance the utility of these cells for research and drug discovery,” said Joydeep Goswami, Vice President, Stem Cells and Regenerative Medicine. “Having the ability to work with karyotypically normal hESCs through our license with WARF allows us to develop better technologies for research, such as more defined media and engineered stem cell lines. This agreement is another step in our strategy of pursuing advances in the high-growth area of regenerative medicine.”

This is interesting in several regards.  WARF appears to be holding it’s own in defending several patents related to hES cells, although the verdict is still out.

Perhaps more interesting is that IVGN’s RegMed group is, I believe, in Frederick.  At least Dr Rao, who is also a VP of the Stem Cell Group, is in Frederick.

Posted in Business, News, Public/Private Companies, Stem Cells | No Comments »

OncoVAX Authorized by Dutch

Posted by Jim H on May 8, 2008

In a press release yesterday, it was announce that Frederick-based Vaccinogen’s potential blockbuster colon cancer “vaccine” therapy has been approved for manufacture at their Emmen, Netherlands facility.

From the FoxBusiness web site:

FREDERICK, Md., May 7, 2008 /PRNewswire via COMTEX News Network/ —-Vaccinogen Inc. said Dutch health authorities licensed it to manufacture its break-through OncoVAX anti-colon cancer vaccine, immediately clearing the path to more than $100 million of potential European sales.

The Dutch approval of the company’s facility based in Emmen, The Netherlands also paves the way to its pivotal US FDA Phase IIIb clinical trial — the final step before the vaccine can be sold in the United States.

“The facility can produce up to 3,500 vaccines annually, equivalent to $130 million in revenues,” said Michael G. Hanna, Jr., Ph.D., Vaccinogen CEO. “That number only scratches the surface of potential demand for a Stage II colon cancer vaccine. One of every three patients who have their cancer removed see it return — and the results are usually fatal.”

“Our experience with OncoVAX has resulted in increasing the patients’ chance of survival by more than 50%,” he concluded. “This represents an opportunity for a new lease on life for tens of thousands of patients around the world.”

The Dutch license permits the company to commercialize the vaccine, first in Switzerland and then in seven other countries in Eastern Europe. The OncoVAX vaccine represents a potential medical breakthrough because it uses a patient’s own cancer cells to prevent the cancer from returning after a successful operation to remove it.

The product is actually not a standard “vaccine” like you’d get for rabies or HPV or influenza.  These vaccines are produced and tested in large batches in fermenters and everyone gets essentially the same dose.  OncoVAX is actually an autologous vaccine, whereby a small section of the excised tumor is sent by the surgeon to the production facility where the tumor section is processed and made antigenic.  It is then injected back into the patient, where their own body produces antibodies to the tumor and kills it.

While Vaccinogen is not the only company working on this new era of “personalized medicine”,  they are among the first to pave the way through clinical trials.  This explains, in part, the extreme effort (in terms of $$ and time) it has taken to get this novel process through the rigors of FDA approval in the States.

Posted in Business, News, Public/Private Companies | No Comments »

There’s No Place Like Home

Posted by Jim H on May 3, 2008

I was remiss in not posting that FITCI hosted the first of the Season Happy Hour & networking event on Friday. I had been in Kansas since Wednesday and was too busy working on my presentation and dodging tornado’s to post. Plus, I forgot to look ahead in my calendar.
The Happy Hour was well attended, by the Chamber of Commerce, RCM&D, OED, Ft Detrick’s tech transfer office and many other people I didn’t have the chance to meet & greet. I had only been back for about an hour, though, from my trip. Since I had to get up at 4 AM to get to the airport, I was pretty exhausted by 4 PM and the happy hour, so I didn’t stay long.

I stopped in to feed my cells, but ended up getting a Biodiesel sample for testing, so I did that instead, then got myself home.

Speaking of events, I will be out at the Greater Baltimore Tech Council’s Golf Classic on Monday May 19th and AFCEA Frederick’s Golf outing Tuesday May 13th at Whiskey Creek. The GBTC event is “SOLD OUT”, but there is still room for both individual golfers and Sponsorships at the Frederick event.

1st Annual AFCEA Golf Tournament

Come Join Us Prior to the Spring Research Festival

Where: Whiskey Creek Golf Course
When: May 13th - 1 pm Shotgun

Contact Abby Richon to sign up or become a sponsor
301-644-3913 x2178
arichon@ape-bio.com
This e-mail address is being protected from spambots, you need JavaScript enabled to view it
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  • Lunch

  • Complementary Beverages on the Course
  • Dinner
  • Silent Auction
  • Hole-In-one Contests
  • Great Networking

$100 per government golfer

$125 per industry golfer

Click here to download PDF for available sponsorships

Posted in Events, News | No Comments »

APE-BridgePath Merger announced

Posted by Jim H on May 1, 2008

This press release came out today through the PRWeb:

Local Biotech Companies Merge Operations

Advanced Product Enterprises and BridgePath Scientific become APE-BridgePath Scientific

Frederick, MD (Vocus/PRWEB ) April 29, 2008 — The Baltimore-Washington metropolitan region is a productive R&D arena, with over $7 billion spent each year on scientific products for research and product development. Two local companies catering to the same target market, but with different niches, have teamed up to offer a spectrum of services to commercial, academic, and governmental research organizations.

Dr. Joseph Garner (left) and Patrick Haley have merged as APE-BridgePath Scientific, providing solutions for research and development institutions.
Dr. Joseph Garner (left) and Patrick Haley have merged as APE-BridgePath Scientific, providing solutions for research and development institutions.
I couldn’t be more pleased with this merger. The combination of the two companies will allow us to serve the biotech industry at-large in a more cohesive manner

BridgePath Scientific and Advanced Product Enterprises, LLC (APE) of Frederick have merged their operations into APE-BridgePath Scientific. “Both companies are currently headquartered at the Frederick Innovative Technology Center incubator,” stated Dr. Joseph Garner, President and CEO of APE. “We have collaborated on a number of projects, and joining the two companies will provide our clients with a complete list of value-added services from one organization. We believe the addition of highly trained and business minded scientists to the product lines sold by BridgePath, will allow APE-BridgePath Scientific to provide a high level of understanding and technical support to commercial, academic, and governmental researchers that is currently lacking in the industry.”

“I couldn’t be more pleased with this merger. The combination of the two companies will allow us to serve the biotech industry at-large in a more cohesive manner,” stated Patrick Haley, President and CEO of BridgePath Scientific. BridgePath Scientific provides scientific and laboratory equipment, supplies and custom research and development product fulfillment. They carry tens of thousands of products. Founder, President and CEO Patrick Haley is an active member of the Frederick community and the State of Maryland. He has served on many business, community, industry, and civic boards and councils, including the Technology Council of Maryland, Goodwill Industries of Monocacy Valley, and the Suburban Frederick Kiwanis Club. Haley is a long time member of the Business Development Advisory Council (BDAC) for Frederick County, currently serving as Chairman, and the Frederick chapter of the Armed Forces Communications and Electronics Association (AFCEA). He is also co-founder and former Chairman of the Board of the Frederick Innovative Technology Center, Inc. (FITCI), Frederick County’s first technology incubator.

Advanced Product Enterprises, LLC provides preclinical contract research for pharmaceutical and vaccine companies along with several scientific research products. Their founders of APE have over 30 years of academic and industry research experience and recently launched APE Biodiesel, providing complete testing for biodiesel fuels. Dr. Joseph Garner, President and CEO of APE, was trained and received his PhD in molecular biology at the University of Maryland and studied at the Center of Marine Biology. He is active in a number of regional and national organizations, including the American Society for Pharmacology and Experimental Therapeutics, the American Society for Biochemistry and Molecular Biology, and the Business Development Advisory Council for Frederick County. Dr. Garner has presented research worldwide at scientific meetings, including Translation UK in Dundee, Scotland and International Marine Biotechnology Conference in Australia.

APE-BridgePath is located in the Frederick Innovative Technology Center’s second incubator located at 4539 Metropolitan Court in Frederick, Maryland. For more information about the company and their services, visit www.bridgepathscientific.com and www.ape-bio.com or call 1-888-496-8333.

Posted in Business, News, Public/Private Companies | No Comments »

In vitro models for human skin Tox studies to be made in Frederick

Posted by Jim H on April 29, 2008

The news keeps coming in for LifeLine, in Walkersville. I was doing research for another project and saw this on their website today:

International Stem Cell Corporation Obtains Exclusive Rights in the US and Canada to Distribute Approved Human Skin Model for Toxicity Testing


OCEANSIDE, California, April 29, 2008


International Stem Cell Corporation (OTCBB: ISCO) announced today that it has entered into an exclusive agreement with CellSystems Biotechnologie to distribute laboratory-cultured models of human skin useful for testing the hazardous properties of consumer products and for dermatological and pharmaceutical research. Such testing is likely to be soon required for certain types of consumer products sold into the European Union.

According to International Stem Cell’s (ISCO) President Jeffrey Janus, “This agreement is another positive step in ISCO’s strategic plan to become the primary source of high quality human cells for the therapeutic and research markets by leveraging its manufacturing and distribution resources.”

ISCO’s human cell and cell culture research products are manufactured and distributed under the “Lifeline” brand by wholly-owned subsidiary Lifeline Cell Technology, LLC, based in Walkersville, Maryland (www.lifelinecelltech.com).
The laboratory-cultured models of human skin, called EST-1000 and AST-2000 were developed by CellSystems and contain cells manufactured by Lifeline. These three dimensional skin cell models are used as alternative methods to animal testing in the field of Skin Corrosion, Skin Irritation, Skin Sensitization, Genotoxicity and Phototoxicity.

“We have worked with the Lifeline staff and know their abilities to provide excellent
customer service and their ability to consistently produce high quality products; a critical factor for researchers that depend on human cells for the success of their research,” said Horst W. Fuchs, President of CellSystems Biotechnologie. This agreement between our companies opens a distribution channel for CellSystems’ skin model products to scientific researchers throughout the United States and Canada.”
“While the sale of these Lifeline stem cell and research products provides ISCO
immediate cash flow, it also helps embed ISCO’s products into successful therapeutic and quality control procedures worldwide, providing a revenue stream of shared royalties beyond traditional sales,” added Janus.

Posted in Business, News, Public/Private Companies, Stem Cells | No Comments »

NCI’s Nanotechnology Characterization Laboratory

Posted by Jim H on April 28, 2008

I ran across this article last week in medicalphysicsweb.com, so might as well post it. All kinds of news from the Fort this week:

Apr 15, 2008

A new take on MRI contrast

The US National Cancer Institute (NCI) has given the go-ahead for preclinical characterization of a nanomaterials-based contrast agent that’s being billed, at least by developers in industry, as “a completely new approach to enhancing contrast during MRI procedures”.

The modified fullerene compound comes from the labs of Luna Innovations, a Roanoke, VA-based technology-transfer company with interests in healthcare, telecoms, energy and defence markets.

Studies of the MRI contrast candidate will include characterization of its physical attributes, its in vitro biological properties and its in vivo compatibility using animal models. Researchers will also examine critical parameters related to distribution, metabolism, elimination and toxicity.

The study programme is expected to take a year from receipt through the in vivo phase. Evaluation will be carried out at the NCI’s Nanotechnology Characterization Laboratory (NCL) in Frederick, MD. The NCL’s remit is to standardize preclinical characterization of nanomaterials intended for therapeutic and diagnostic applications.

“The outcome of this characterization study is the report necessary for an Investigational New Drug application,” said Chris Kepley, nanoimmunology group leader at Luna and principal investigator on the study. “The process of getting a new drug to market can be a lengthy one. However, with the NCL behind us we hope to move forward more quickly bringing to market a next-generation solution for MRI contrast agents.”

Posted in Government Funded research, News | No Comments »

Baylog’s Biotech

Posted by Jim H on April 27, 2008

I’ve enjoyed Jason Balog’s write-ups about Biotech in the FNP. I believe this is the second one.  He seems to have an interesting angle on the events of the times and certainly has a good grasp of the local Biotech scene.

Among the interesting points:

  • approximately two dozen lawmakers were forming a biotechnology and life sciences caucus to promote the industry throughout the state.
  • The Biotechnology Investment Incentive Tax Credit remained intact and was again funded in the budget at the amount of $6 million
  • The Md Stem Cell Research fund “did suffer a cut, I am happy to report that lawmakers settled on $19 million for the fund with $1 million more possible, depending on the availability of extra money from the Cigarette Restitution Fund.”
    • My Rant here:  Funding Stem Cell research with tobacco money? Oh, the horror.  In case you forgot, a vast majority of MdSCRF funding went to Hopkins who, by the way, already make a boat load of cash treating patients who use tobacco.

And the summary paragraph:

It was a quiet year in the legislature on the life sciences front. The current budget situation did not allow for the expansion of current programs or the initiation of new programs. However, momentum continues to build for the life sciences industry in the state as reflected by the creation of the new biotechnology and life sciences caucus. Many anticipate that the next two legislative sessions are going to be critical for the industry to grow in Maryland, and assuming that the economy cooperates I would expect to see new and exciting initiatives to help Maryland become the premier location for the life sciences industry.

Posted in Funding Available, Government Funded research, News, Rants, Stem Cells | No Comments »

Recent News and Links with the past

Posted by Jim H on April 25, 2008

I have been busy the past few days and haven’t been able or motivated enough to put a real post together. So this morning, after being reminded that I had left MedImmune off the Companies list (which is one of the most popular Pages on the Blog in terms of hits), I wanted to take a step back to a press release from Feb. 6th from a new company started in Frederick County named Vaccinogen. This could be a really big story if they are able to demonstrate this process is effective.

Here’s the blurb from their web site:

Frederick, MD – February 6, 2008 – Cancer research pioneer Michael G. Hanna Jr. Ph.D., also Vaccinogen, Inc.’s Founder, Chairman and CEO has acquired the rights to OncoVAX®, a vaccine with the potential to prevent colon cancer from recurring in many patients.

“This agreement represents a major step forward in defeating cancer by increasing the body’s immunity to it,” said Dr. Hanna, who has been working on cancer vaccines for more than 30 years.

“This agreement represents a major step forward in defeating cancer by increasing the body’s immunity to it.”

In the agreement, Vaccinogen obtained exclusive license to OncoVAX® Active Specific Immunotherapy as well as an important component of the product TICE BCG. The vaccine is made from the patients’ own tumor and is injected back into the patient to effect an immune response against recurrence of that cancer.

The FDA views Stage II colon cancer as an unmet medical need. When colon cancer recurs after surgery it is frequently fatal. OncoVAX® prevents that recurrence and thereby reduces recurrence and deaths by over 50%. Vaccinogen is currently preparing to commercialize the vaccine in Switzerland.

I should also post an update off their web site from Feb 27th, that announces the availability of the vaccine in Europe:

Frederick, MD – February 27, 2008 –Vaccinogen, Inc. announced that its new vaccine to block colon cancer from recurring will be commercially available in Europe starting June 2008.

“This makes OncoVAX® the world’s first commercially viable vaccine for colon cancer,” said Dr. Michael G. Hanna, Jr., Ph.D., Chairman & CEO of Vaccinogen. “It is the beginning of our worldwide strategy of profitable distribution. Questions of the feasibility of patient specific anti-cancer therapies have been raised and this new European initiative will obviate these issues.”

Pro Vaccine AG, a leading Swiss-based pharmaceutical distributor, will begin distributing OncoVAX® throughout Switzerland starting with Zurich and Neuchâtel by June 2008. “We are very excited about the prospects of offering OncoVAX® to Swiss and foreign patients,” said Renato Duckeck, GM of Pro Vaccine.

Pharmacenter Hungary, a rapidly growing oncology company that commercializes a broad portfolio of oncology treatments, will begin distributing the vaccine in Hungary, Czech Republic, Slovakia, Poland, Romania, Bulgaria and Slovenia starting in the third quarter of 2008. Dr. Christian Galli, Director of Business Development of Pharmacenter Hungary noted, “We recognize the excellent opportunity OncoVAX® provides us and the growing population of colon cancer patients in Eastern Europe.”

And I also wanted to go waay back to an article I started a post about in January that ran in the FNP when Vaccinogen first started. From the FNP, 1/22/08:

A company that uses a unique system to fight colon cancer has opened in Frederick.

Vaccinogen, located at 5300 Westview Drive, uses some of the patient’s own cancer cells to help cure the disease.

The company is headed by Michael Hanna, director of the National Cancer Research Center in Frederick from 1975 to 1983.

“At that time, I headed the entire operation,” he said of the cancer center. “We went from a small center to 50 buildings.”

After he left, the center’s operations were broken into several divisions, each headed by a different director, he said.

Although a resident of Bethany Beach, Del., Hanna said he is happy to be back in Frederick. It seemed the perfect place to locate the headquarters for his company.

Vaccinogen has a manufacturing plant in Emmen, Holland.

Although still undergoing studies here for approval, Vaccinogen’s system is being used in Switzerland.

“It is considered a transplant there,” Hanna said.

The immunotherapy, known as OncoVAX, follows surgery for removal of Stage II colon cancer. The tumor cells are processed in the facility in the Netherlands.

A specific vaccine is created using those cells and injected into the patient in four doses during a six-month period. The vaccine unleashes the body’s own immune system to fight cancer cells.

“It is the first time a patient-specific therapy has been successful,” Hanna said.

“We have done all the hard work. There are final clinical trials that need to be done,” he said.

Even though it was put on the fast track by the federal Food and Drug Administration, it will be four years before OncoVax could be on the market in the United States, Hanna said.

He said he would like to eventually build a manufacturing plant in the U.S., most likely in Baltimore.

“It is truly a Frederick product,” Hanna said. Research for the process began at the Frederick Cancer Research Center.

When he left the local cancer research center, Hanna ran a research institute for Litton Bionetics on individualized targeted therapy. That institute was later acquired by Azko Nobel. At that time, Hanna’s research team also developed a treatment for bladder cancer that is considered the standard for today.

Hanna acquired the OncoVaX technology and formed a company called PerImmune in 1997. In 1998, PerImmune merged with Intracel Corp., but Hanna continued to hold OncoVAX assets and formed Vaccinogen.

More than $300 million has been spent on research during the 35 years of OncoVax’s development.

Besides Switzerland, and eventually the U.S., Hanna said the company is working to market the product in Eastern Europe and other locations.

I knew a bit about the history of Vaccinogen before this story came out because we were doing a little work with their predecessor, Intracel, as they were closing up operations. Intracel also made HDL and LDL, which I believe Vaccinogen also acquired and is making today. Anyway, they have real nice History and TimeLine pages, with nostalgic pictures scrolling across the top of their About Us page.


So here’s where the story gets real interesting. The whole thing started in the 60’s with the formation of Litton Bionetics, which became a popular target of the conspiracy theorists in the 90’s due to their links with the military and germ warfare. It is a documented fact that Litton Bionetics was a major Defense Contractor of the time and the recipient of a1970 Dept. of Defense appropriations request for 10 million dollars for a 5 year study to develop immune system targeted micro-organisms for germ warfare. What they did with the money is where people get excited.

This research was overseen by Dr. Hanna the likes of emerging giants in the field such as Dr Robert Gallo, working at the National Cancer Institute at the time. To make a long story short, the conspiracy theorists claim, amongst other things, that this group is responsible for introducing AIDS & Ebola as a contaminant in a polio or small pox vaccine used in Africa in the 70’s. The allegation is that the vaccine was contaminated with monkey retrovirus that were used in germ warfare experiments.

Quite frankly, I was expecting to do a brief post on he topic, but my research took a strange turn towards the bizarre I had not anticipated. A long, unsubstantiated rumor, or maybe just a bit more Frederick County Biotech folklore?

And I thought Stem Cells were controversial……

Posted in Business, Government Funded research, News, Public/Private Companies, Rants, Rumors, Stem Cells, bizzare | 2 Comments »

BioBeers East III

Posted by Jim H on April 19, 2008

BioBeers was yesterday, and it was good. We had about 20-25 people from across the county. I was stressed that I haven’t been able to pry anyone out of Ft Detrick, so we’ll work on that for the next one. Also a little disappointed that the Gazette didn’t show up this time. They came to the last one, when there were only 2 people. Oh well. For those of you who said you were coming and didn’t, you missed out on a good time. FiberCell Systems, Kforce Scientific, Gahaga and APE-BridgePath Scientific supplied the munchies and Jim (our Flying Dog Host) even pitched in a batch of Gonzo Imperial Ported soaked onions & kraut for the Brats.

BioBeerIII

Here’s a list of who we had:

Lonza, MedImmune, Lentigen, DynPort, Integrated Biotherapeutics, Meso Scale, Gene Choice, Marligen, Quanta, Chesapeake Pearl, APE-BridgePath, Veracity, KPL, FiberCell Systems, Worthington Enzymes, Genova, Gahaga Biosciences. There are more, but I am going to have to go look up the roster. IN the mean time, please enjoy the attached slide show!

Posted in Events, News | No Comments »

BioBeers Update

Posted by Jim H on April 13, 2008

A quick BioBeers III Update.

The next event will be held this Friday, April 18th at 5 PM at the Flying Dog Brewery in Frederick.

We’re well over the 15 person “private tour” qualification, with 21 people RSVPing in the affirmative thus far. It is still not too late to RSVP, but at this point, you can just show up on a whim.  Feel free to forward this invitation to friends or other interested parties or to bring a date/significant other if you think they’ll tolerate a Friday night out with a bunch of Science Geeks consuming fermented beverages.

Attendees will cover a good spectrum of different groups in the county (we’re even letting people in Montgomery county to attend) including people from DynPort, Amaxa, Integrated Biotherapeutics, Veracity Biotechnology, FiberCell Systems, The NIH, Lonza, MedImmune, Advanced Product Enterprises, BridgePath Scientific, NABI, LifeLine Cell Technologies, Quanta, Marligenand a few others who wish to remain anonymous. I am hoping to hear from a couple people from Fort Detrick, SuperArray, Akonni and Invitrogen

I am also glad that we have 2 sponsors, thus far. FiberCell Systems will be supplying Brats for the grill and Kforce Scientific Staffing is going to bring some other munchies. Mix that with a couple of the 8-16 different beers Flying Dog will have on tap and a few old faces: this could be the most important biotech networking event in Frederick County this year. At least until we have another Happy Hour at FITCI once the weather breaks.

There are also ample facilities for making a presentation. If you have data, an idea to pitch, a story or wares to sell, let me know. We can set that up.

I started BioBeers “East” borrowing the model established by the original group in Colorado. A fundamental objective is to promote our region as the top-tier bio-cluster in the country by showing we are a thriving and nurturing bio-entrepreneurial community. BioBeers is intended to be a catalyst, where like minded bio-preneurs gather regularly to share ideas, cultivate business relationships and build lifelong friendships.

I hope you will join us.

Posted in News, Public/Private Companies | No Comments »