“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,” Michael S. Weiss, executive chairman and CEO of TG Therapeutics, said in a press release.
Ublituximab is an antibody designed to prevent B-cells from triggering the inflammation that causes nerve cell damage in MS. It does so by targeting a protein called CD20 that’s found on the B-cell surface.
The therapy, administered directly into the bloodstream (intravenously), has shown the ability to reduce relapse rates and improve disability scores in people with relapsing forms of MS and active disease enrolled in the ULTIMATE 1 (NCT03277261) and 2 (NCT03277248) twin Phase 3 trials.
Based on the results of those clinical trials, TG Therapeutics is preparing a biologics license application, or BLA, to send to the U.S. Food and Drug Administration in the third quarter of this year, or by the end of September. That application will request ublituximab’s approval for this MS population.
“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,” Weiss said, adding that the expanded contract “is an important next step in our long-standing relationship with Samsung.”
In particular, the treatment reduced the risk of relapse by 50–60% compared with Aubagio, and lowered the number of T1 and new or enlarging T2 lesions by more than 90%. T1 lesions are areas of active inflammation, while T2 lesions are areas of brain damage regardless of inflammation.
More than 40% of participants in both trials showed no evidence of disease activity over approximately two years, translating to a 198% improvement over Aubagio in ULTIMATE I and a 277% relative improvement in ULTIMATE II.
Finally, while rates of disability progression were similar for ublituximab and Aubagio, the proportion of patients with a confirmed improvement in disability scores — meaning they had less disability — was much higher for ublituximab.
The new manufacturing deal will enable TG Therapeutics to expand its production capacity for ublituximab, should the medication gain regulatory approval. Samsung is building its fourth and largest biomanufacturing facility to date, in Incheon, South Korea, with a planned 620,000 liters of biomanufacturing capacity.
Samsung expects to complete the plant in 2023.
“We are very glad to be able to flexibly accommodate our client’s expanded needs through our facilities,” said John Rim, CEO of Samsung Biologics.
“By supporting TG Therapeutics in this partnership, we are contributing to bringing needed treatments to patients around the world,” he added.
Ublituximab also is being developed as a non-chemotherapy medicine for cancer patients with B-cell malignancies.
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