Samsung Biologics and TG Therapeutics expand collaboration on ublituximab
South Korean contract development and manufacturing organization Samsung Biologics (KRX: 207940.KS) and US biotech TG Therapeutics (Nasdaq: TGTX) have 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, whose shares closed up nearly 5% at $44.43 yesterday on the news, has completed a rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration requesting approval of ublituximab, in combination with Ukoniq (umbralisib), TG Therapeutics’ oral once-daily inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL), based primarily on the positive results from the UNITY-CLL Phase III trial. Ublituximab was also the subject of two successful Phase III trials in patients with relapsing forms of multiple sclerosis (RMS) and a BLA is currently being prepared for this indication.
Financial terms of the accord
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