Omeros, a clinical-stage biopharmaceutical company, has selected a clinical candidate for its MASP-2 antibody program based on successful preclinical studies and has initiated the cGMP manufacturing development process in preparation for clinical trials.
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Reportedly, preclinical studies have shown that Omeros’ proprietary, fully human, monoclonal MASP-2 antibodies shut down the lectin pathway of the complement system, which is part of the immune system.
The lectin pathway is involved in multiple inflammatory disorders and, in independent studies, patients who are genetically deficient in the pathway have been shown to have better clinical outcomes. MASP-2 inhibition has also demonstrated efficacy across a wide range of preclinical disease models.
MASP-2 (mannan-binding lectin-associated serine protease-2) is a novel pro-inflammatory protein target in the complement system. Omeros has generated several fully human, high-affinity antibodies that have the ability to block MASP-2. MASP-2 is a key protein involved in activation of the complement system, which is a critical component of the innate immune system.
Gregory Demopulos, chairman and CEO of Omeros, said: “MASP-2 is an exciting target and, with our recent licensing of Helion’s intellectual property, we have now consolidated within Omeros the worldwide exclusive rights to MASP-2 inhibition and the antibodies that target the protein.
“The preclinical data support our lead antibody’s potential for broad utility in both orphan and major-market diseases. In addition, the clinical utility and commercial value of complement inhibition has been validated by the first and, currently, the only complement antibody on the market.”
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