Seattle, US-based Omeros Corporation has developed OMS721 (narsoplimab), a human monoclonal antibody (mAb) targeting mannan-binding lectin-associated serine protease-2 (MASP-2), for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
The deal extends Lonza’s multi-year manufacturing agreement with Omeros, in which the former provides the clinical supply of narsoplimab.
The two companies have now decided to extend the partnership for the product’s commercial manufacture, ahead of anticipated regulatory approvals.
Omeros will submit a biologics license application (BLA) and a marketing authorization application (MAA) to the US Food and Drug Administration (FDA) and to the European Medicines Agency (EMA), respectively.
To date, there is no approved product for the treatment or prevention of HSCT-TMA, and narsoplimab is the only drug in development for the treatment of HSCT-TMA filed for FDA’s designation.
The company has reached an agreement with the FDA regarding the primary endpoint of the product’s trials, with the company suggesting it is ‘confident’ that its study and treatment will be able to meet.
According to the company, the primary endpoint requires the investigational drug to show both a beneficial effect on the underlying HSCT-TMA disease and a meaningful improvement in patients’ clinical status. It also includes laboratory measures and markers of organ function, as well as platelet and red blood cell transfusion burden.
The drug product is also currently being investigated by Omeros as a potential treatment for immunoglobulin A (IgA) nephropathy, atypical hemolytic uremic syndrome (aHUS), lupus nephritis and other renal diseases.
The company has previously commercialized Omidria (phenylephrine and ketorolac intraocular), which is indicated for the prevention of intraoperative floppy iris syndrome (IFIS),
While Lonza has been investing in its drug substance production, with its most recent announcement to be the expansion of its bioconjugation facility in Visp, Switzerland producing antibody-drug conjugates.
Regarding monoclonal antibody (mAb) manufacture, the contract development and manufacturing organisation (CDMO) has also recently agreed to provide manufacturing for Alector’s Phase I drug candidates for neurodegenerative diseases.