Biolex Inc. has closed a $24.4 million fourth round, almost $10 million over the amount it said it was looking for earlier this year.

Biolex, which uses the green aquatic plant Lemna to express human proteins for therapeutic drug use, assembled a stellar group of new, current, and corporate investors in closing the round.

Jan Turek, chief executive officer of Biolex tells Local Tech Wire, “Clearly the round was over-subscribed. The last couple of years has been a difficult time to raise money. But due to the strong technical and business milestones the company achieved in the last year or so, we put together a prestigious syndicate that includes international investors like Mitsui and corporate investment arms of major pharmaceutical companies.”

Quaker BioVentures, Philadelphia, PA and Intersouth Partners, Durham, led the round, which also include five new investors and all of its existing investors. New investors are Johnson & Johnson Development Corp., Mitsui & Co. Venture Partners, The Dow Chemical Co., Dogwood Equity, and Trelys Venture Partners. Existing investors are The Wakefield Group, Kitty Hawk Capital, Franklin Street Partners, Tall Oaks Capital and Academy Centennial Fund.

Turek says the financing will enable the company to “put Good Practice Manufacturing (GPM) facilities in place and advance its lead drug into human clinical trials within the next two years.” Biolex already has Good Laboratory Practice facilities in a little more than 20,000 square feet of its 38,000 square foot labs and offices in Pittsboro.

“Now as we advance our own compounds and those of our collaborators to the clinic, we’ll need the GMP facilities in place, so we’ll build out the rest,” Turek says. The U.S. Food and Drug Administration requires drug makers to adhere to rigorous guidelines in developing lab and manufacturing facilities.

Hiring Ten
Turek says 35-employee Biolex will hire about 10 additional staff members in research and bioprocessing. “We’re almost a poster child for the state’s new initiative to become a leader in bioprocessing,” he adds.

Turek says the Biolex lead development candidate is alpha interferon, which has multiple uses in fighting cancer, Hepatitis C, and other diseases. Biolex plans to submit an Investigative New Drug Application to the FDA for alpha interferon in the next 12 months. “We’re currently deciding which indication to do that for,” Turek says.

Biolex will also focus on turning its collaborations into long-term development agreements, he says.

Biolex has active collaborations underway with four biopharmaceutical companies, including Bayer, Centocor and Debiopharm.

“We believe that Biolex is uniquely poised to transform protein drug development and production economics and capabilities across the industry,” said P. Sherrill Neff, Managing Partner of Quaker BioVentures. “Biolex technology is robust and efficient across a wide range of hard-to-make protein types, including large proteins, smaller peptides, and antibodies.”

Quaker BioVentures is a dedicated life science venture capital firm, focused on companies in the Mid-Atlantic region, from New York to North Carolina. It leads investments in companies at all stages of development and across the life science industry.

The Biolex Lex System combines desirable natural characteristics of the Lemna plant with advanced genetic engineering and protein recovery methods. The company says this provides the most desired qualities of cell cultures made from animal sources, the current gold standard, and also characteristics sought in the next generation systems for protein expression.

Lemna Advantages
Lemna grows so fast it speeds up producing human proteins for early evaluation. It also easily scales up to make larger quantities of proteins for clinical testing and finally production. It has high protein content and replicates clonally. It needs much less complex facilities than other ways of making proteins in a contained and controlled environment. The company says it substantially reduces capital requirements and operating costs for producing human therapeutic proteins.

“Intersouth has been impressed with the significant progress that Biolex has made since its inception. We are excited to be working with Biolex and its world class management team to accelerate the availability of innovative drugs to the market,” commented Mitch Mumma, General Partner of Intersouth Partners.

Turek says, “We are now well positioned to maximize the benefits of the LEX System for the expression of human therapeutic proteins. We have a strong patent position, a FDA-agreed production approach and have put in place a top-level management team with extensive industry experience in therapeutic proteins. Our mission at Biolex is to become the premier plant-based therapeutic protein company.”

Biolex raised a total of $33.5 million in venture funding with this round. The company’s technology is based on research by its founder and chief scientific officer, Anne-Marie Stomp, Ph.D, at North Carolina State University. Biolex licenses the Lemna System technology from NCSU.

“We expect this to be our last venture financing,” says Turek. “We believe with the proceeds from this one we can put assets in place to bring in revenue and make us attractive for another key financing event.”