Just a week after announcing a 30 percent reduction in its workforce, Gaithersburg biotech GenVec reported a new $3.5 million agreement with the Naval Medical Research Center to support its malaria vaccine development.
GenVec is to produce clinical supplies of the vaccine, based on its proprietary technology. The research center plans to test the safety and efficacy of the vaccine. GenVec will retain rights to commercialize the technology, according to a company statement. The delivery system can generate strong immune responses while avoiding the problems of vector-specific immunity that has hampered other vectored vaccines.
Data presented in 2010 show that the vaccine was safe and well-tolerated when given to healthy subjects.
“We appreciate the U.S. military’s continued commitment to the worldwide problem of malaria and its support of malaria vaccine development,” Joseph Bruder, director of research and head of GenVec’s malaria program, said in the statement. “Work under this agreement will build upon the encouraging clinical results previously demonstrated in malaria with our vaccines.”
Malaria kills about 863,000 people annually.
GenVec also reported that promising data on its respiratory syncytial virus vaccine program were presented at a symposium in Santa Fe, N.M., last week.
Tested in cotton rats and mice, the vaccine candidate was “highly immunogenic” and produced “durable and broad protection from a single intramuscular administration,” according to a company statement.
There is no approved vaccine for the disease, which infects nearly all U.S. children younger than 2, causing 130,000 hospitalizations annually. The disease kills about 15,000 institutionalized elderly people a year.
In other Maryland bioscience industry news:
Aeras has landed a $299,525 grant from the Food and Drug Administration to help it research biological and immunological biomarkers for tuberculosis vaccines.
The Rockville nonprofit said it is developing an assay designed to “drastically reduce the time and cost of developing new vaccines against tuberculosis.”
“Next to new vaccines, no tool is more important to the TB vaccine field than the identification of an assay that can reproducibly predict whether a vaccine will work in human populations,” Mike Brennan, senior adviser of global affairs at Aeras, said in a statement. “The FDA has recognized this and through its innovative Critical Path Program has provided significant support to make the development of this new tool a reality.”
Aeras already has received $553,425 from the FDA during the past two years for this project, which it is conducting with researchers at St. Louis University, the University of Oxford (U.K.), the Albert Einstein College of Medicine and the South African Tuberculosis Vaccine Initiative.
Akonni Biosystems reported winning a $280,784 grant from the National Institutes of Health to develop an automated sample preparation workstation for isolating nucleic acids from lysis-resistant targets, such as staphylococci, including methicillin-resistant Staphylococcus aureus, streptococci and tuberculosis.
At first, the system will be used for research, with clinical applications expected later.
“This will bring a new level of automation efficiency and cost savings for sample preparation to research labs and eventually clinical laboratories around the world,” Christopher Cooney, principal investigator of the project and director of engineering at the Frederick company, said in a statement. “This new platform will be compatible with a simple-to-use consumable kit and will be capable of purifying nucleic acid from 12 samples in less than 20 minutes, making it valuable to a broad range of molecular and hospital laboratories, including those operating in global health settings.”
The market for the test could be significant. About 5 percent the nation’s 40 million hospital visits are complicated by a hospital-acquired such as MRSA or tuberculosis, Akonni said, citing a Kalorama Information 2012 report, “Hospital Acquired Infections: Testing Markets.”
ChiRhoClin of Burtonsville reported that it has received federal regulatory approval to again market ChiRhoStim, its orphan drug product that helps diagnose pancreatic cancer and pancreatic exocrine dysfunction.
The Food and Drug Administration is permitting the company to market the product until its new manufacturing facility is operational in the beginning of 2013, the company said in a statement.
“One of ChiRhoClin’s main goals is to generate grants to help fund pancreatic research for the medical community,” Skip Purich, vice president of marketing and operations, said in the statement. “With the release of ChiRhoStim, researchers studying the pancreas now have a tool that can facilitate their research.”
Sigma-Tau Pharmaceuticals reported winning FDA approval for its treatment to treat corneal cystine crystal accumulation as a result of cystinosis.
The Gaithersburg company worked with the National Institutes of Health to develop the topical ophthalmic therapeutic, called Cystaran, which is designated an orphan drug in the U.S., with seven years of market exclusivity.
“This new medicine will offer physicians the only FDA-approved treatment for patients with corneal cystine crystal accumulation, many of whom are children and whose lives are seriously impacted by this debilitating chronic condition,” COO Dave Lemus said in a statement.
Cystinosis affects about 300 children and young adults in the U.S. and 2,000 worldwide, according to Sigma-Tau. It’s a rare, genetic lysosomal storage disease, with abnormal accumulation of the amino acid cystine. It causes cystine crystals to build up in various parts of the body, including corneas, kidneys, liver, pancreas, muscles, brain and white blood cells. In corneas, it can lead to complications such as squinting, foreign body sensations, changes in visual acuity, corneal haziness and sensitivity to light.
Osiris Therapeutics of Columbia has wrapped up its collaborative agreement with Genzyme, with all global rights to its Prochymal and Chondrogen stem cell products reverting to Osiris.
Osiris now can commercialize or make new agreements with other companies without limitation, according to a company statement.
Prochymal is approved in Canada and New Zealand to treat acute graft-vs.-host disease in children who have marrow transplants. Seven other nations, including the U.S., make it available under an expanded access program for treatments for which there is no approved therapy.
Osiris also reported that Swiss authorities have put approval of Prochymal on the fast track in that nation.
The treatment also is in a phase 3 trial for refractory Crohn’s disease and trials to treat heart attacks and type 1 diabetes.
Chondrogen is in clinical trials to treat osteoarthritis in the knee.
Tendyne Holdings of Baltimore raised $8.97 million of a $23 million equity offering from 20 investors, it said in a regulatory filing.
The startup develops medical devices for structural heart disease.
BioElectronics has a new distribution agreement with Zephyrus to market its electronic pain-relief and healing patches in Albania, Bosnia and Herzegnovina, Croatia, Kosovo, Macedonia, Montenegro, Serbia and Slovenia.
“This is a growing part of the world that is beginning to prosper,” Ben Fichter, marketing manager for the Frederick company, said in a statement. “We believe the populations of these countries will embrace a safe, drug free, inexpensive product that provides more effective pain relief than any drug therapy.”
BioElectronics also signed deals with companies to distribute the patches in Costa Rica and Ecuador.