#TGTX "announced its financial results for the third quarter endedSeptember 30, 2020and recent company developments.
Recent Developments and Highlights
ASH 2020 Presentations: • Four abstracts have been accepted for presentation at the upcoming 62nd American Society of Hematology (ASH) annual meeting, to be held virtually December 5 – 8, 2020, including: • Results from the UNITY-NHL Phase 2 marginal zone lymphoma (MZL) and follicular lymphoma (FL) umbralisib monotherapy cohorts • Results from the UNITY-CLL Phase 3 trial evaluating the combination of umbralisib and ublituximab (U2) in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia (CLL) • Two triple therapy presentations, one evaluating the combination of U2 plus venetoclax in CLL, and a another evaluating the combination of U2 plus TG-1701, our BTK inhibitor, in patients with B-cell malignancies • Abstracts were made available last week and a call was held with leading investigators from our trials to review the data included in these abstracts. A replay from this call is available on our corporate website at https://ir.tgtherapeutics.com/events.
UNITY-NHL: Umbralisib Monotherapy Marginal Zone Lymphoma & Follicular Lymphoma Cohorts • In July 2020, we announced the publication of preclinical data describing the unique immunomodulatory effects of umbralisib in Blood Advances, a Journal of the American Society of Hematology. • In August 2020, the U.S Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) for umbralisib as a treatment for patients with previously treated MZL and FL. The NDA was based primarily on data from the umbralisib monotherapy MZL and FL cohorts of the UNITY-NHL Phase 2b trial. The MZL indication, under Breakthrough Therapy Designation (BTD), has been accepted for Priority Review and has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021. The FL indication has been accepted for standard review with a PDUFA goal date of June 15, 2021.
UNITY-CLL: Ublituximab and Umbralisib (U2) in Chronic Lymphocytic Leukemia • In October, the FDA granted Fast Track Designation to the combination of ublituximab and umbralisib (U2) for the treatment of adult patients with CLL, which could potentially expedite the development and regulatory review of U2. The application for Fast Track was based on data from the UNITY-CLL Phase 3 Study.
Key Objectives for Remainder of 2020 and Early 2021
Report topline results from the Phase 3 ULTIMATE I & II trials in Multiple Sclerosis
Present full data from the UNITY-CLL Phase 3 trial and from the FL and MZL single agent umbralisib cohorts of the UNITY-NHL trial at ASH 2020 as well as data from our triple therapy combinations of U2 plus venetoclax and U2 plus 1701, our BTK inhibitor
Target an NDA/Biologics Licensing Application (BLA) submission of U2 for the treatment of patients with CLL (including both previously untreated and relapsed/refractory patients)
Complete enrollment in ULTRA-V Phase 2b trial
Continue to advance our early pipeline candidates including our anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), our covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, and our anti-CD47/CD19 bispecific antibody, TG-1801
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