Based: Cambridge, MA
The Scoop: A rich partnership pact with GlaxoSmithKline last October kept Tolerx in the race to develop an anti-CD3 monoclonal antibody for autoimmune disease. That program is now headed into Phase III, and all the chips are on the table.
What makes it Fierce: Anyone looking to strike a partnership deal would do well coming even close to Tolerx. Within days of the news that MacroGenics had struck a billion-dollar deal with Eli Lilly for its program to develop a monoclonal antibody for immune disease, Tolerx struck back with a $760 million pact in the same space.
Tolerx is at a crucial stage of its development. An end-of-Phase-II meeting with the FDA went well, setting up a late-stage trial for otelixizumab--a monoclonal antibody that binds to CD3--in new-onset type 1 diabetes.
"In the meeting with the FDA March 20 we discussed not only the Phase I and II program, but also the requirements for a BLA filing," says CEO Douglas Ringler. "That all went extremely well and now we're actively enrolling in the U.S. We intend to get other European and Canadian sites up by the end of summer."
Tolerx has good cause to be working with a sense of urgency. Ringler knows only too well that the company has strong competition for its development program. The deal with GlaxoSmithKline also has a crucial co-promotion arrangement for the U.S. market. And the company is working to create a commercial infrastructure as it expands its pipeline and starts making post-BLA plans.
Tolerx also hit a key milestone in its development pact with Genentech when it announced in January that TRX1, an anti-CD4 monoclonal antibody, completed a Ib trial in subjects with refractory cutaneous lupus erythematosus. New MAbs are in preclinical development.
When FierceBiotech spoke with Ringler in early June, the company had 55 staffers. That figure should rise to 75 by the end of the year, including a new hire for a senior marketing executive.
What to look for: Late-stage data will mark a key turning point for Tolerx, which has enormous potential advancing a new diabetes drug. It's all about executing on the plan, says Ringler. So far, the company has attracted more than $118 million in financing from investors. A successful Phase III would offer a big reward.