- Lonza will manufacture drug substance for clinical supply of HaemaLogiX’s lead drug candidate for multiple myeloma, KappaMab, at its new state-of-the-art facility in Canton (NC)
- HaemaLogiX will leverage Lonza’s regulatory expertise, global manufacturing footprint and extensive experience in monoclonal antibody manufacturing
BASEL, Switzerland and SYDNEYJan. 272022 /PRNewswire/ — 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 pharmaceutical, biotechnology and nutritional 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 that binds to a cell surface target called kappa myeloma antigen (KMA) which is only found on myeloma cancer cells and not on normal plasma cells. The specific binding of KappaMab to the myeloma cell allows 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 cancer cells are depleted and normal healthy plasma cells are spared from attack by the patient’s immune system.
To date, KappaMab has been tested in three clinical trials where it has shown a good safety profile without any dose-limiting toxicity after single and multiple doses,,. In a recent phase 2b clinical trial, KappaMab in synergy with the immune modulator drug (IMiD) lenalidomide in combination with dexamethasone to produce more disease responses and better quality of response compared to paired lenalidomide plus dexamethasone alone in patients with relapsed multiple myeloma and refractory.
Bryce CarmineChief Executive Officer, HaemaLogiX, said: “Multiple myeloma is the second most common blood cancer worldwide, with approximately 32,000 new cases and more than 12,500 deaths per year in the United States alone (2019), and a roughly equivalent European incidence. The incurable nature of multiple myeloma makes it necessary to expand the treatment options available to patients. We look forward to bringing KappaMab back into the clinic alongside the standard of care, and this agreement from Lonza is an important step towards supplying the drug product for our next trial.
Under the terms of the agreement, Lonza will manufacture KappaMab’s drug substance for clinical supply at Lonza’s new state-of-the-art cGMP mammalian manufacturing facility in Canton (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 monoclonal antibody manufacturing.
Jeetendra Vaghjiani, Executive Director, Clinical Development and Strategic Marketing, Lonza, commented: “We look 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 industry-leading expertise in monoclonal antibody manufacturing at our Canton (CN).”
The target completion date for the drug product is Q4 2022. The drug product will then be used in Australia-based clinical trials, which are currently scheduled to begin in late 2022.
Lonza is the preferred global partner for the pharmaceutical, biotechnology and nutrition markets. We work to enable a healthier world by helping our customers deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled range of offerings enable our customers to commercialize their healthcare discoveries and innovations.
Founded in 1897 in the Swiss Alps, Lonza today operates on five continents. With approximately 15,000 full-time employees, we are made up of high-performing teams and individual talents who make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 2.5 billion with a CORE EBITDA of 847 million francs in H1 2021. Learn more about www.lonza.com.
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About HaemaLogiX Ltd – www.haemologix.com:
Founded in 2014, HaemaLogiX is an unlisted, public biotech company researching antibody therapies for multiple myeloma. Multiple myeloma is a hematological (blood) cancer of plasma cells (B cells) that can cause targeted damage to a patient’s bone marrow. Multiple myeloma is considered treatable but generally incurable. The HaemaLogiX team has extensive experience in antibody research, non-clinical and clinical development, manufacturing and commercialization. Members of the Scientific Advisory Board (SAB) are internationally recognized experts in monoclonal antibody therapies and hematology. Our current research and clinical trial partners are world leaders in the treatment of multiple myeloma and AL amyloidosis. HaemaLogiX is located at Sydney, Australia.
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 Spencer A, Walker P, Asvadi P, et al. A preliminary study of the anti-κ myeloma antigen KappaMab (MDX-1097) monoclonal antibody in treatment-experienced patients with κ-restricted multiple myeloma. Blood cancer J. 2019; 9(8):58.
 Kalff A, Shortt J, Yuen F, et al. A sequential cohort study comparing kappamab alone with kappamab, lenalidomide, and low-dose dexamethasone in refractory relapsed kappa-restricted multiple myeloma (AMaRC 01-16). Blood. 2019; 134(Supplement_1): 3144-3144.
 Spencer A, Augustson B, Mollee P, Copeman M, Asvadi P, Dunn R. Phase 2a, multiple-dose, open-label study of the anti-kappa monoclonal antibody, MDX-1097, in relapsed kappa-chain-restricted multiple myeloma with stable measurable disease. The European Hematology Association (EHA). Stockholm, Sweden; 2013.