Over a decade of research may soon yield product

LOGICAL APPROACH: Yow-Pin Lim, foreground, founder of ProThera Biologics with ProThera lab scientists Andre Santoso, right, and Ryan Denckewicz. / PBN PHOTO/TRACY JENKINS
LOGICAL APPROACH: Yow-Pin Lim, foreground, founder of ProThera Biologics with ProThera lab scientists Andre Santoso, right, and Ryan Denckewicz. / PBN PHOTO/TRACY JENKINS

It’s been a dozen years since Brown University Warren Alpert Medical School professors Yow-Pin Lim and Douglas Hixson made the jump from scientists to entrepreneurs with the founding of ProThera Biologics LLC.
Now, backed by more than $8 million in state and federal research investments, ProThera can see a day when its work on life-threatening diseases will become a treatment.
The East Providence startup is encouraged by the results of an animal study funded by the National Institutes of Health into whether its technology is an effective protection against anthrax.
The company recently moved into a new office and laboratory space in the former FujiFilms building on Massasoit Avenue in the waterfront district, which will allow it to scale up production of trial materials.
And after being funded through government grants and Rhode Island’s Slater Technology Fund to this point, Lim said ProThera is now looking for investors. “When we started, we didn’t know what this molecule could do,” Lim said, “and now we know more clearly the potential. The approval we got in principle and in several animal models gives us more confidence, we are on the right track.”
ProThera’s first chance to implement its research could come next year with the conclusion of the animal study, which is expected to provide the data needed to market a treatment to the U.S. government as a bio-defense agent.
Like most biotech concerns, reaching a broader medical market will take still longer due to the demands of the Food and Drug Administration pharmaceutical approval process.
“Right now we are testing efficacy on anthrax, but it could be avian flu or swine flu or a number of biological agents – the problem now is it is one bug one drug, but potentially how many drugs can be bioweapons,” Lim said. “Biodefense is one thing, but our focus ultimately is sepsis, systemic inflammation. We can use this for a whole range of clinical diseases.”
The idea behind ProThera Biologics is actually a set of proteins produced by the liver, called inter-alpha inhibitors, whose properties were discovered accidentally in the labs of Rhode Island Hospital. Lim and Hixson were making monoclonal antibodies and accidentally discovered a tool for detecting these proteins. Then they discovered that patients with severe sepsis, a condition in which the body is overwhelmed by infection, happened to have unusually low levels of the proteins, around 20 percent of what they found in healthy people.
Through further research, Lim and Hixson came to believe that the inter-alpha inhibitors protected the body from the damaging inflammation that occurs during serious infections.
With many infectious diseases, Lim said, inflammation actually poses the greatest threat to patients, and if it can be reduced, antibiotics and anti-retroviral drugs can be given time to work.
Ultimately, Lim sees ProThera’s breakthrough leading to treatments of severe sepsis, systemic inflammation, acute respiratory distress syndrome and cancer.
And along with drugs, ProThera is working on a simple, fast way to test patient levels of inter-alpha inhibitors so clinicians can tell if someone they are treating is in danger.
From the initial discovery of a link between inter-alpha inhibitors and inflammation, ProThera was able to secure a $100,000 grant from the Slater Fund in 2001 and then a $2.8 million NIH grant in 2006.
That combination of Slater, Rhode Island’s public-venture capital fund, and the NIH have provided the financial resources to get ProThera to where it is. In total, Slater has invested $1.35 million in ProThera, with the most recent a $750,000 convertible loan last year.
Since the first grant in 2006, ProThera has secured $7.2 million from NIH to study biologic drugs using inter-alpha inhibitors.
The current round of study runs through next June and involves testing the effectiveness of ProThera’s treatments on rabbits and baboons. Unlike consumer drugs, which require extensive human trials, bio-defense agents need to be proven on two animals followed by a much more basic test for human safety. Because of federal rules for the use of biological agents, the rabbit tests are being conducted at Boston University’s National Emerging Infectious Diseases Laboratories, and the baboon tests are being done at labs in Oklahoma.
But to make the drugs necessary for the tests, ProThera needed to increase its production capacity in East Providence and that required a “clean room,” something the company’s former base on Warren Avenue didn’t have.
As other biotech companies have learned, ProThera did not have an easy time finding suitable laboratory space in Rhode Island.
Discussions about the problem with others in the industry helped form the Rhode Island Bioscience Leaders, a 1-year-old group designed to help life sciences entrepreneurs.
Eventually, connections at Slater pointed ProThera to the Fuji building, which had a clean room that the Japanese film company had vacated in favor of a new facility in North Kingstown.
The new labs are three times the size of ProThera’s old Warren Avenue space, plenty of room to accommodate the company’s seven employees.
“The original reason why we formed Rhode Island Bioscience Leaders was space – companies including ProThera were all looking for space,” said Edward G. Bozzi, assistant clinical professor in the University of Rhode Island’s biotechnology manufacturing program.
The lack of laboratory space for startups, who can rent bench space in other cities, has been a recurring issue in Rhode Island and spurred talks about a facility in Providence’s Knowledge District. That may be addressed in Brown’s South Street Power Station plans.
In the long term, if ProThera does turn its advances into an approved drug, Lim said it will probably be manufactured in a dedicated facility elsewhere, but he hopes to keep research in Rhode Island. •

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