Wednesday, January 11, 2012

Microtest to make ImmusanT celiac vaccine for trials

By Rodney H. Brown

ImmusanT Inc. has picked Agawam’s Microtest Laboratories to manufacture the Cambridge biotech’s Nexvax2 immunotherapeutic vaccine for its expected upcoming clinical trial as a treatment for celiac disease.

Contract manufacturer Microtest will also provide pharmaceutical testing services in support of the upcoming clinical trial, according to a release from Microtest. That support will include such things as method transfer activities, complete final product release testing, storage and stability.

According to the release. ImmusanT’s $20 million fundraise last month was in support for moving Nexvax2 forward into clinical trials. Safety, tolerability and bioactivity of Nexvax2 have already been established in a Phase 1 clinical study, officials said. The $20 million Series A round of funding that ImmusanT landed in December came from Vatera Healthcare Partners LLC of New York. 

The Nexvax2 vaccine triggers an immune response that is intended to allow celiac disease to be treated like a simple allergy with regular injections. Celiac disease is an autoimmune condition in which the body cannot tolerate gluten, the main protein in wheat, rye and barley. ImmusanT co-founder and Chief Scientific Officer Bob Anderson identified the three peptides, which make gluten toxic to people with celiac disease.

ImmusanT was founded with an unspecified amount of seed funding, President and CEO Leslie Williams said in a previous interview, from “high net worth individuals.” The company, founded in 2010, officially launched earlier this year. The Nexvax2 vaccine has already gone through a Phase 1 clinical trail to test for safety, tolerability and bioactivity, the company said in a release.