Samsung Biologics, the world’s leading contract development and manufacturing organization and TG Therapeutics, announced an expansion of a large-scale contract manufacturing deal for the supply of TG Therapeutics’ ublituximab, an investigational anti-CD20 monoclonal antibody.
TG Therapeutics has completed a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, in combination with UKONIQTM (umbralisib), TG Therapeutics’ oral once-daily inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with CLL, based primarily on the positive results from the UNITY-CLL Phase 3 trial. Ublituximab was also the subject of two successful Phase 3 trials in patients with relapsing forms of multiple sclerosis (RMS) and a BLA is currently being prepared for this indication.
“We are very glad to be able to flexibly accommodate our client’s expanded needs through our facilities,” John Rim, CEO of Samsung Biologics, commented. Rim added, “By supporting TG Therapeutics in this partnership, we are contributing to bringing needed treatments to patients around the world, and getting a step closer to our vision of bringing about a better life for humanity.”
Michael S. Weiss, Executive Chairman and CEO of TG Therapeutics, stated, “Samsung is the global leader in biologics manufacturing and we are happy to have them as our partner as we look forward to the potential commercialization of ublituximab across both oncology and autoimmune indications. With the recent positive ULTIMATE I and II MS Phase 3 studies, we re-evaluated our supply needs and were very pleased we were able to secure the long-term capacity we believe we will need to meet the potential global demand for ublituximab. This is an important next step in our [long-standing] relationship with Samsung.”
In order to support all its current and potential clients around the world, Samsung Biologics is currently building its fourth and largest biomanufacturing facility in Incheon, Korea. Upon completion of the said plant in 2023, Samsung Biologics will hold 620,000 liters of biomanufacturing capacity, or approximately a quarter of the entire bio-CMO capacity globally. The company provides contract manufacturing, contract development, and testing services all from a single location, offering end-to-end services for its clients.
ABOUT UBLITUXIMAB
Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell. Additionally, ublituximab is uniquely designed, to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of B-cell malignancies and autoimmune disorders, both diseases driven by the abnormal growth or function of B-cells.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, TG has received accelerated approval from the U.S. FDA for UKONIQ™ (umbralisib), for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has two programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development.
ABOUT SAMSUNG BIOLOGICS CO., LTD.
Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.
