XBiotech is developing a first-in-class monoclonal antibody (MABp1) to inhibit chronic inflammation. Chronic (sterile) inflammatory responses are involved in the progression of many serious and common diseases. Thus commercialization of MABp1 represents a unique blockbuster-potential impact to medicine and industry.
The MABp1 product candidate had its historic launch at MD Anderson Cancer Center in February 2010, where it has since been used to treat various forms of cancer, including lung, colorectal, endocrine, sarcoma and lymphoma. Based on these results, the Company has received Fast Track designation by the FDA and has launched a Pivotal Phase III study for the treatment of advanced colorectal cancer.
XBiotech has also received FDA Fast Track designation regarding its development program for MABp1 for the treatment of restenosis after revascularization procedures. XBiotech has completed clinical proof of concept studies using MABp1 in other important areas of medicine, including Type 2 Diabetes, Psoriasis and Acne.
MABp1 is a True Human™ antibody cloned from a natural human immune response. XBiotech expects True Human™ monoclonal antibodies to exhibit the best potential tolerability and safety for therapeutic antibodies. Clinical results to date with MABp1 support this thinking. The Company has a proprietary discovery platform for True Human™ antibodies.
XBiotech has established a manufacturing process for its antibody therapy that uses disposable technology to reduce infrastructure and go-forward operating costs. This technology also minimizes lead times and maximizes flexibility compared to existing manufacturing operations that rely on stainless steel bioreactor systems.
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