The two companies first initiated collaboration back in February 2018.
This expanded contract is worth US$50.3m to Samsung, a near US$30m increase on the original US$22.4m CMO deal, a spokesperson for the Korean CDMO told BioPharma-Reporter.
Michael S Weiss, CEO of TG Therapeutics, said the partnership with Samsung will ensure stable supply of ublituximab as it looks to the potential commercialization of the drug.
“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.”
TG Therapeutics has completed a rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) requesting approval of ublituximab, in combination with UKONIQ (umbralisib), its oral once-daily inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL), one of the most common types of adult leukemia.
The BLA is 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.
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, explained the developer. 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, it said. “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.”.
Samsung Biologics provides contract manufacturing, development, and testing services from a single location, offering end-to-end services for its clients. To meet growing demand for such services it has been building its fourth and largest bio-manufacturing facility in Incheon, west of Seoul.
Currently the CDMO runs three plants there capable of producing 362,000 liters, which is the world's largest production volume.
Upon completion of the new facility in 2023, Samsung will be able to produce 620,000 liters, making it the largest CMO facility at a single location. The new site will also provide a full range of CDO, CMO, and CRO processes including early-stage development capabilities and large-scale commercial manufacturing with integrated aseptic fill/finish capabilities and a full QC lab for testing services. The production volume from its four plants will account for about 25% percent of the global CMO market.
In 2020, Samsung signed US$1.7bn in CMO contracts – a record-breaking figure – and opened the company’s first overseas CDO R&D center in San Francisco.