Two Maryland biotechs have won federal Small Business Innovation Research grants to battle malaria, a deadly scourge in the developing world.
Protein Potential of Rockville won a $300,000 phase 1 grant from the National Institutes of Health to work with Aduro BioTech of Berkeley, Calif., to develop two novel malaria vaccines to be administered sequentially.
It's the third innovation grant that Protein Potential has won from NIH this year involving malaria research. The company also has won others previously.
Both the experimental vaccines stimulate immune responses that target the circumsporozoite protein antigen of Plasmodium falciparum, the parasite that causes malaria deaths, mostly in Africa, according to B. Kim Lee Sim, the company's president. The novel regimen is designed to induce the spectrum of immune responses that scientists think is essential for long-lasting protection.
Protein Potential, which Sim founded in 2003, also has a phase 2 innovation grant from NIH to develop a vaccine for another strain of malaria parasite called plasmodium vivax, which is more prevalent in Asia, especially India, Sim said.
The company also has a "big project" in the works targeting bioterrorism threats, she said. The company is working on a technology that uses salmonella as a carrier, or vehicle, to develop oral vaccines targeting typhoid fever and anthrax.
Besides its research work, the company also develops target molecules, mainly proteins, for clients that use them, from discovery research to clinical trials, said Sim, who worked at Rockville biotech EntreMed for 10 years before launching Protein Potential. The company has no backers, she said, relying instead on research grants and contracts.
The company is closely tied to Sanaria of Rockville — which also develops products targeting malaria — in more ways than one. Not only do the companies share office space and Sanaria's 40-plus employees, but Sim is married to Stephen Hoffman, who is CEO of Sanaria and chairman of Protein Potential. And Sim is vice president of process development and manufacturing for Sanaria.
Meanwhile, Fyodor Biotechnologies of Baltimore won a $476,000 innovation grant from the National Science Foundation to develop a test to detect the two main strains of malaria parasites in urine. Current diagnostics use blood and require laboratories for analysis.
"We believe that when fully developed, this broad-based ... dipstick test will drive current global effort towards home-based diagnosis of malaria within 24 hours in all cases of fever," Eddy Agbo, CEO of Fyodor, said in a statement. "Attaining this target is currently impossible with the diagnostic tools available today.”
Most malaria deaths occur within 48 hours of the onset of symptoms, according to information from the 4-year-old biotech, and fast diagnosis will mean more prompt treatment.
There are about 216 million cases of malaria globally each year, with more than 655,000 deaths in 2010. More than 80 percent of the fatal cases are in children younger than 5, mostly in Africa, according to the World Health Organization.
In other Maryland bioscience industry news:
MacroGenics will receive $20 million — and up to $1 billion — under a new development and commercialization deal with a French pharmaceutical company.
Servier of Suresnes will work with MacroGenics on the Rockville biotech's Dual-Affinity Re-Targeting products designed to redirect the body's immune system to attack tumor cells. The technology involves a single recombinant molecule that can target two different antigens.
"We are delighted to enter into our second collaboration with Servier and our third major pharmaceutical partnership around our DART platform," CEO Scott Koenig said in a statement. "Servier has been an extraordinary partner with significant global capabilities in developing and delivering novel cancer treatments to patients."
MacroGenics will retain all development and commercialization rights to the three pre-clinical programs in the U.S., Canada, Mexico, Japan, Korea and India, while Servier has the option to obtain an exclusive license covering the rest of the world for each of the programs. Meanwhile, both privately held companies will fund and conduct research and development activities.
All told, MacroGenics could receive more than $1 billion in clinical, regulatory and commercialization milestone payments for the three programs. MacroGenics also might receive tiered, double-digit percentage royalties on net sales.
A Bethesda company reported winning a two-year, $2.7 million contract from the Army to develop a hand-held device to quickly diagnose traumatic brain injury in the field.
The contract will help BrainScope merge the technologies in its system with current smartphone technology, the company said in a statement.
The technology records brain electrical activity with a handheld, non-invasive, non-radiation emitting medical device, and utilizes advanced algorithms that quantify and characterize features of brain electrical activity associated with traumatic brain injuries, including concussions, according to the company. The system is intended for use as an adjunct to standard clinical practice.
"We are honored to receive this award from the U.S. Army to create a more miniaturized version of our handheld device on a ubiquitous computing platform," CEO Michael Singer said in the statement. “We understand the significant need for a rapidly-applied assessment capability with results displayed in minutes so that first responders can make vital triage decisions."
The new deal follows a $7.5 million Pentagon contract in December to study BrainScope's technology in emergency room settings.
Northwest Biotherapeutics reported that it plans to proceed with a phase 1-2 clinical trial of its DCVax-Direct treatment for all solid tumor cancers. The Food and Drug Administration has approved the trial.
The Bethesda company is in late-stage discussions with medical centers in the U.S. and Europe that would work with it on the trial, which will treat 36 patients.
The experimental treatment is for tumors that are considered inoperable, including tumors in the lungs, colon, pancreatic, liver, ovarian, head and neck. The treatment is injected directly into the tumor.
The new treatment is similar to the company's other cancer vaccines. One, to treat brain cancer, is in a phase 3 trial; another, to treat prostate cancer, has received FDA clearance to begin.
In pre-clinical animal trials, the new treatment shrank not only the injected tumor, but others in the body, indicating a systemic immune response, Northwest said in a statement. When the treated animals were re-injected with cancer cells, they did not develop cancer again.
"Based upon the pre-clinical studies showing regression of existing tumors, DCVax-Direct may offer a much needed new treatment option for patients suffering with inoperable tumors today," CEO Linda Powers said in a statement.
United Therapeutics signed a new deal with Ascendis Pharma to apply its proprietary TransCon technology platform to United Therapeutics' treprostinil molecule, the active ingredient in its Remodulin injection for pulmonary arterial hypertension.
The Silver Spring drug-maker said in a statement that the Ascendis technology may enable a controlled, long-acting release of a novel, carrier-linked product, which would give patients the option of injecting themselves, rather than receive the drug through a continuous infusion pump.
"Pre-clinical studies in multiple animal models with a lead compound of TransCon-linked treprostinil have already produced encouraging results, demonstrating a sustained release profile supportive of once-daily injection," Roger Jeffs, COO and president of United Therapeutics, said in the statement.
"The application of TransCon technology to treprostinil may also minimize injection site pain and reactions that frequently occur with continuously infused subcutaneous Remodulin," Jeffs said.
United Therapeutics also will have exclusive rights to develop prostacyclin, prostacyclin analog and prostacyclin-related products for treatment of pulmonary arterial hypertension using the TransCon technology, and will hold worldwide commercial rights to products resulting from the collaboration. Ascendis has its U.S. headquarters in Palo Alto, Calif.
Neuralstem, the Rockville biotech developing a stem cell treatment for amyotrophic lateral sclerosis and other conditions, reported raising $7 million in a sale of common stock.
The infusion of new cash comes on the heels of a new study showing that the company's stem cell treatment could help paralyzed rats with severed spinal cords regain motor function.
RegeneRx Biopharmaceuticals received a patent in Mexico for the use of its thymosin beta 4 compound to treat dry eye syndrome, glaucoma and other indications.
The patent is projected to expire in July 2026, according to a statement from the Rockville biotech.