HaemaLogiX Ltd (HaemaLogiX), the clinical-stage biotechnology company developing novel monoclonal antibody therapies for multiple myeloma, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, 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[1],[2],[3]. 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[2].
Bryce Carmine, Chairman and CEO, HaemaLogiX, commented: “Multiple myeloma is the second most common haematological cancer worldwide, with an estimated 32,000 new cases and over 12,500 deaths annually in the US alone (2019), and a European incidence roughly equivalent. The incurable nature of multiple myeloma makes it necessary to expand treatment options available to patients. We look forward to taking KappaMab back into the clinic alongside standard of care, and this Lonza agreement is an important step toward providing the drug product for our upcoming trial.”
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.
Jeetendra Vaghjiani, Executive Director, Clinical Development & Strategic Marketing, Lonza, commented: “We are looking forward to building a collaboration with HaemaLogiX to help advance their multiple myeloma candidate towards commercial launch. We will leverage our unique flexible offering and state-of-the-art expertise in manufacturing monoclonal antibodies at our site in Guangzhou (CN).”
The target completion date for the drug product is Q4 2022. The drug product will then be used in Australian-based clinical trials, currently scheduled to begin in late 2022.