Driven by its recent $179 million federal contract to develop seasonal and pandemic flu vaccines, Novavax is expanding its operations with its move from Rockville to Gaithersburg next year.

The company always had intended to use its current 51,200-square-foot facility at 9920 Belward Campus Drive for producing only small batches of vaccines for early-stage clinical trials, said CFO and Vice President Frederick W. Driscoll. The new contract with the Biomedical Advanced Research and Development Authority will involve manufacturing more vaccines, and the new 74,000-square-foot facility at 20-22 Firstfield Road will have double the production capacity of its Rockville location.

The move will allow for a “seamless transition,” Driscoll said.

“We would have had to renovate here [in Rockville] — we would have had to shut down” to increase the company’s pilot plant’s capacity, he said. “We need a commercially viable manufacturing facility.”

Roughly 10,000 square feet of the company’s current quarters is devoted to manufacturing.

Because Novavax won’t move its corporate, research and manufacturing operations until the new property is modified — probably sometime in mid-2012, although corporate functions might shift sooner — “we won’t lose any down time,” Driscoll said.

Company officials are assessing what to do with the Rockville facility. One possibility is to retain it for small-scale manufacturing, he said.

Novavax signed a long-term lease on the Gaithersburg property with owner Alexandria Real Estate Equities of Pasadena, Calif. Driscoll said he could not disclose details. In a statement, President and CEO Stanley C. Erck called the terms “very favorable.” Scheer Partners of Rockville represented Novavax in the transaction.

This year, Novavax has added 16 employees, bringing its work force to 106, Driscoll said. The new federal deal likely will mean hiring a dozen or so more workers in the next 12 to 18 months.

The company focuses on developing vaccines using its virus-like particle technology, which genetically mimic viruses and other pathogens and are non-infectious. Because they are not produced with eggs, the way most vaccines are, they can be manufactured more quickly in response to outbreaks, according to the company.

Novavax reported total assets of $67.1 million as of Sept. 30, down from $74.8 million Dec. 31. It reported a third-quarter net loss of $3.2 million.

The global vaccine market is expected to reach $27.6 billion by the end of this year, climbing to $33 billion by 2013, according to a new report, “Global Vaccine Market Forecast to 2013."

In other Maryland bioscience industry news:

Human Genome Sciences got some disappointing news last week when the compound it licensed in 2004 to GlaxoSmithKline to treat type 2 diabetes failed to meet its primary endpoint on non-inferiority.

The study is designed to compare albiglutide, an investigational once weekly product that the Rockville biotech created, to once-a-day liraglutide, an approved treatment for type 2 diabetes, according to a statement from the U.K. pharma giant and HGS partner on its new lupus drug.

The primary endpoint of the 841-patient, eight-nation study was reduction in HbA1c, a marker of the amount of glucose in the blood.

HGS is entitled to fees and milestone payments of as much as $183 million — including at least $33 million received as of this year — in addition to single-digit royalties on worldwide sales if albiglutide is commercialized, according to HGS.

GlaxoSmithKline is continuing its development efforts.

“While the pre-specified margin of non-inferiority was not met, these topline data support continued progression towards registration of albiglutide as a possible future once weekly treatment for type 2 diabetes,” said Moncef Slaoui, chairman of research and development, in the statement. “This is the first of eight phase 3 studies to conclude and we continue to look forward to receiving the results of the remaining studies which will provide a more complete assessment of the profile of albiglutide in type 2 diabetes.”

Northwest Biotherapeutics, which is developing cancer vaccine treatments, has raised $5.4 million in new financing.

The Bethesda biotech reported $2.4 million in new debt, plus an agreement to purchase the first $3 million in common stock under an agreement announced in June for an equity facility of as much as $25 million during a 30-month term.

"We are pleased to see the growing investor interest in providing further financing to the Company,” CEO Linda Powers said. “These positive financial arrangements will help us continue to ramp up and accelerate our programs, including our 240-patient clinical trial of DCVax for Glioblastoma multiforme brain cancer in both the U.S. and Europe."

Emergent BioSolutions has launched a new trial to assess the immunogenicity and safety of a three-dose vaccination schedule of its BioThrax vaccine given to people exposed to anthrax.

The Rockville biotech hopes to obtain from regulators a post-exposure prophylaxis indication for BioThrax, according to a company statement.

That would expand use of the vaccine beyond its current pre-exposure indication, allowing the vaccine to be given together with antibiotics to people who might have been exposed to anthrax spores.

BioThrax is the only anthrax vaccine licensed by the U.S. Food and Drug Administration.

The new study involves 200 healthy adult volunteers and will be conducted at four U.S. sites, with preliminary data expected in the fourth quarter of 2012.

“Patient 13” is the first in Neuralstem’s ongoing stem cell trial to receive an injection of the treatment in the cervical, or upper back, region of the spine.

The Rockville biotech is studying the safety of its spinal cord neural stem cells to treat amyotrophic lateral sclerosis. The initial 12 patients received stem cell transplants in the lumbar, or lower back, region. All told, six patients are to be treated in the cervical region.

“The ultimate goal of transplanting cells into this region is to preserve or even enhance breathing capacity for the patients,” said Eva Feldman, director of the A. Alfred Taubman Medical Research Institute, director of research of the ALS Clinic at the University of Michigan Health System and an unpaid company consultant, in a statement.

"Successfully intervening in the cervical region entails enhanced risk, but also the possibility of dramatically enhanced benefit to the patients,” Karl Johe, the company’s chairman and chief scientific officer, said in the statement.

The phase 1 trial began in January 2010 at Emory University and is designed to enroll up to 18 patients.

Lentigen is working with University Hospitals Case Medical Center and Case Western Reserve University School of Medicine in Cleveland to launch a phase 1 clinical trial of a treatment to help brain cancer patients deal with the toxic effects of chemotherapy.

The privately-held Gaithersburg biotech is developing a gene therapy, LG631, designed to protect stem cells from the dose-limiting toxicity of chemotherapy with Temodar. If it works, it would improve the tolerance and efficacy of the chemotherapy, according to a Lentigen statement.

Only about 2 percent of the about 17,000 Americans diagnosed annually with glioblastoma survive longer than five years, according to Lentigen. Treatment typically involves surgery, then radiation therapy and chemotherapy to destroy remaining cancer cells. Merck’s Temodar is a standard treatment.

The phase 1 trial will evaluate the safety of LG631 its potential to enhance current treatments.

"The initiation of this [National Cancer Institute]-supported study represents an important milestone in the development of Lentigen's pipeline," CEO Tim Ravenscroft said in the statement. "It is the first of several products which we expect to enter the clinic in the next 12 months.”

RegeneRx Biopharmaceuticals reported two cardiac-related patents will be allowed in Australia and Mexico.

The Australian patent is for treating or preventing damage because of heart failure and will expire in July 2026, according to a statement from the Rockville biotech, while the Mexican patent is for treating or preventing damage caused by increased blood flow in the myocardium and will expire in January 2026.

RegeneRx has similar patents pending in other countries, including in the U.S., Asia and Europe.

Profectus BioSciences of Baltimore reported it has won more funding from the PATH Malaria Vaccine Initiative to support studies in non-human primates with its technologies designed to help develop a prophylactic malaria vaccine.

“We believe our vaccine technology can be successfully applied to a wide range of pathogens, including malaria, which has proven to be a very challenging target for vaccine development,” John Eldridge, chief scientific officer, said in a statement.

Researchers from the J. Craig Venter Institute of Rockville and University of Minnesota have sequenced and published a draft genome of the model legume, aka "barrel medic." The results were published in the online edition of the journal Nature.

The team reconstructed 375 million base pairs, capturing nearly 94 percent of the genes, according to an institute statement.

The study might lead to improvements in other legumes, such as alfalfa, whose roots have nitrogen-fixing qualities.

BioFactura won a U.S. patent covering the core technologies of its proprietary StableFast Biomanufacturing Platform, which the Rockville company is marketing to companies developing biopharmaceuticals including novel compounds and biosimilars with a focus on therapeutic monoclonal antibodies.

“This patent represents years of innovation and development by the BioFactura team that includes the Company's original founders,” CEO Darryl Sampey said in a statement.

Nuvilex is hailing the results of new testing confirming live cell encapsulation technology can overcome two major obstacles facing applications of live stem cells.

SG Austria, working with the Silver Spring company, is conducting studies of encapsulated stem cells in its laboratories in Singapore, according to a Nuvilex statement.

The main challenges are producing sufficient quantities of live, pure, “virgin” stem cells that can change into any cell type and preventing their migration from the site of insertion — and encapsulation addresses both challenges, Nuvilex said.

“As a result, large pharmaceutical and biotechnology companies have approached us, studying the technology for potential use with their existing products,” according to the statement. “Nuvilex believes it is important shareholders realize how monumental a discovery this is.”

“Nuvilex is very excited by these latest laboratory advances,” CEO Robert Ryan said in the statement. “This work makes major contributions to solving some problems and hurdles stem cell therapies face before being implemented into clinical use. We believe the value and potential to handle stem cells through this technology will help in efforts to partner with other biotechnology and pharmaceutical companies as they expand their stem cell products."

Intrexon’s human therapeutics division in Germantown is collaborating with Adeona Pharmaceuticals of Ann Arbor, Mich., in which Adeona will develop and commercialize a DNA-based therapeutic using Intrexon's technologies to treat pulmonary arterial hypertension.

Intrexon will be responsible for technology discovery efforts and managing the patent estate, plus certain aspects of manufacturing, according to a joint statement. Adeona is to conduct preclinical and clinical development of candidates, and handle manufacturing and commercialization efforts.

Intrexon's synthetic biology technology is designed to create what it calls “Better DNA” at industrial scale, providing “speed, flexibility, consistency and precision to the design, production and testing of rationally designed complex transgenes and their encoded genetic circuits.”

“Current sales of approved therapies for [pulmonary arterial hypertension] are an estimated $3 billion per year,” Adeona CEO James S. Kuo said in the statement. “While current therapies may improve quality of life, they have for the most part shown only modest improvements in survival, if any. We believe that by having the ability to correct what is considered to be a critical pathophysiological defect … we may have the opportunity to fundamentally change the course” of the disease.

Pending regulatory approval, the deal calls for Adeona to issue to Intrexon 10 percent of its shares, plus 10 percent more when the first patient is dosed in a phase 2 clinical trial of its candidate using Intrexon technology. Adeona also is to pay Intrexon half of the cumulative net quarterly profits derived from the sale of products developed from the collaboration.

Intrexon’s headquarters are in Blacksburg, Va.

rrand@gazette.net