By the end of this year, the people at Tolerx Inc. will have a good sense of what they have created with $150 million of investment over the past decade. If the Cambridge company has played its cards right, it should have positive results from a pivotal clinical trial of a drug with an unorthodox approach for fighting Type 1 diabetes. Tolerx said in January that it completed enrollment of all 240 patients in a clinical trial of the drug.
“This is a new therapeutic paradigm. It represents opportunities and challenges,’’ says Doug Ringler, the company’s cofounder and chief executive. “This isn’t a cure, but the data we have so far suggest it’s the closest thing to a cure we have.’’
Tolerx, which has about 70 employees and was founded in 2000, has raised cash from HealthCare Ventures, Skyline Ventures, and Sprout Group and secured support from the Juvenile Diabetes Research Foundation. Pharmaceutical giant GlaxoSmithKline signed on to codevelop Tolerx’s lead drug candidate, otelixizumab, in October 2007, in a deal that could eventually be worth as much as $760 million.
From the start, the company hoped it create drugs to treat autoimmune diseases by training the immune system to “tolerate’’ the healthy tissues that it attacks in such ailments, which include Type 1 diabetes, rheumatoid arthritis, and psoriasis. Tolerx is pursuing its vision initially in patients newly diagnosed with Type 1 diabetes. It could eventually offer an eight-day course of daily intravenous infusions of otelixizumab that could help preserve patients’ natural ability to produce insulin for years, reducing the amount of insulin they need to inject on a daily basis to control their blood sugar. If the drug proves its mettle in the current trial, it could be a big step for about 30,000 patients diagnosed with Type 1 diabetes in the United States each year, and for a similar number in Europe.
The Tolerx drug is designed to alter the balance between two key classes of immune system cells: the T effector cells that attack viruses and bacteria and the T regulatory cells, or “T regs,’’ that normally keep the T-effectors in check. One theory with Type 1 diabetes is that this balance tilts too heavily toward T effectors, which attack the insulin-producing cells of the pancreas, known as beta cells. So Tolerx’s plan was to design an antibody to hit CD3, a marker on T effector cells.
The belief was that the single eight-day course of the drug could suppress the overactive T effector cells and essentially give the T regs a chance to recover their normal state of balance and hold the T-effectors in check over time, Ringler said.
LUKE TIMMERMAN
Isis Biopolymer, a Providence developer of drug-delivery devices, has raised $3 million in equity financing, according to a document filed with the Securities and Exchange Commission. It does not list the investors; chief executive Emma Durand was not immediately available for comment. The company has developed a patch that uses embedded computer chips, thin-film batteries, and other technology to deliver drugs through the skin.
Stemgent Inc., a provider of biological materials for life-sciences research, with offices in Cambridge and San Diego, will invest $4.5 million over the next three years in Ubiquigent. The Dundee, Scotland, biotechnology company is producing products developed by the Scottish Institute for Cell Signalling at the University of Dundee. Stemgent is handling initial marketing of the fledgling Scottish biotech’s products in the United States.
TransMedics Inc., an Andover developer of systems for transporting organs for transplant, has pulled in $35.4 million in an equity offering that includes about $9 million from convertible debt. Partners Flagship Ventures, Foundation Capital, and Kleiner Perkins Caufield & Byers are listed as directors in documents filed with the government. In 2008, TransMedics withdrew its plans for an initial public offering worth up to $86 million, due to market conditions.
Cambridge start-up Zafgen Inc., which is focused on developing obesity treatments, has raised $8.1 million in a funding round, a spokeswoman confirmed. Zafgen has now raised $30 million. It received the fresh capital from previous backers Third Rock Ventures in Boston and Atlas Venture in Waltham. Chief executive Tom Hughes this year said the company isn’t exactly sure how its drugs work, after a study showed that its earlier hypothesis that its molecules cut off the blood supply to fat tissues turned out be wrong.
This report was compiled by the editors of Xconomy, an online news website focused on the business of technology and innovation. For more New England coverage, visit www.Xconomy.com/boston. 
