HaemaLogiX Ltd. and Lonza have entered into an agreement to manufacture the next clinical batch (cGMP) of HaemaLogiX's lead multiple myeloma drug candidate, KappaMab. KappaMab is a monoclonal antibody which binds to a cell surface target called kappa myeloma antigen (KMA) that is only found on myeloma cancer cells and not on normal plasma cells. Specific binding of KappaMab to the myeloma cell enables the patient's immune system to recognize the cell as abnormal, triggering the natural response to attack and kill the myeloma cell.

As a result, only the cancer cells are depleted and normal healthy plasma cells are spared from the patient's immune system attack. To date, KappaMab has been tested in three clinical trials where it showed a good safety profile with no dose-limiting toxicities following single and multiple doses. In a recent phase 2b clinical trial, KappaMab synergized with the immune modulator drug (IMiD) lenalidomide in combination with dexamethasone to produce more disease responses and improved quality of response versus case-matched lenalidomide plus dexamethasone alone in patients with relapsed, refractory multiple myeloma. According to the terms of the agreement, Lonza will manufacture drug substance of KappaMab for clinical supply at Lonza's new state-of-the-art cGMP mammalian manufacturing facility in Guangzhou (CN), which houses two 1,000-liter and two 2,000-liter single-use bioreactors.

HaemaLogiX will leverage Lonza's regulatory expertise, global manufacturing footprint, and extensive experience in manufacturing monoclonal antibodies.