On November 2, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that four abstracts have been accepted for presentation at the upcoming 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition, to be held virtually December 5 – 8, 2020 (Press release, TG Therapeutics, NOV 2, 2020, View Source [SID1234569661]). Abstracts will be made publicly available online on November 5, 2020 at 9:00 AM ET via the ASH (Free ASH Whitepaper) meeting website at www.hematology.org. The Company will also host a zoom conference call with leading investigators from the UNITY-NHL and UNITY-CLL trials on Thursday, November 5, 2020, beginning at 8:45 AM ET. Details about the ASH (Free ASH Whitepaper) presentations and the conference call are outlined below.
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Michael S. Weiss, Executive Chairman and Chief Executive Officer, stated, "We are excited to have four abstracts accepted for presentation at the upcoming ASH (Free ASH Whitepaper) conference highlighting data from two registration directed trials, the UNITY-CLL Phase 3 trial of ublituximab in combination with umbralisib (U2) in CLL, and the UNITY-NHL MZL and FL/SLL umbralisib monotherapy cohorts. Our NDA for umbralisib monotherapy for previously treated MZL and FL is currently under review, and we are actively preparing a BLA/NDA submission for the U2 combination for CLL to be submitted in the coming months based on the results of the UNITY-CLL Phase 3 study. Demonstrating the potential to build upon these backbone regimens, there will also be two triple therapy datasets presented, one with U2 plus TG-1701, our BTK inhibitor; and one with U2 plus venetoclax in CLL. We look forward to the abstracts being released publicly on November 5 at 9 AM ET and to reviewing the exciting data on a conference call that morning."
ASH 2020 PRESENTATION DETAILS:
Oral Presentation Title: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study
° Publication Number: 543
° Oral Session: 642. CLL: Therapy, excluding Transplantation
° Session Date and Time: Monday, December 7, 2020; 7:00 AM – 8:30 AM (Pacific Time)
– Presentation Time: 7:15 AM (Pacific Time)
° Presenter: John G. Gribben, D.Sc., F.R.C.P., F.R.C.Path., F.Med.Sci., North East London Cancer Research Network Centre, Barts and the London Cancer Center, UK
Poster Presentation Title: Umbralisib, the Once Daily Dual Inhibitor of PI3Kδ and Casein Kinase-1ε Demonstrates Clinical Activity in Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: Results from the Phase 2 Global UNITY-NHL Trial
° Publication Number: 2934
° Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
° Date and Time: Monday, December 7, 2020; 7:00 AM – 3:30 PM (Pacific Time)
° Presenter: Pier Luigi Zinzani, MD, Institute of Hematology, "L. e A. Seràgnoli", University of Bologna, Italy
Poster Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax (U2-Ven) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) ° Publication Number: 3137
° Session: 642. CLL: Therapy, excluding Transplantation: Poster III
° Date and Time: Monday, December 7, 2020; 7:00 AM – 3:30 PM (Pacific Time)
° Presenter: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, NY
Poster Presentation Title: Clinical Activity of TG-1701, As Monotherapy and in Combination with Ublituximab and Umbralisib (U2), in Patients with B-Cell Malignancies
° Publication Number: 1130
° Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I
° Date and Time: Saturday, December 5, 2020; 7:00 AM – 3:30 PM (Pacific Time)
° Presenter: Chan Cheah, MD, Sir Charles Gairdner Hospital, Hollywood Private Hospital, University of Western Australia, Blood Cancer Research Western Australia
Abstracts will be made publicly available online on November 5, 2020 at 9:00 AM ET via the ASH (Free ASH Whitepaper) meeting website at www.hematology.org and will also be accessible via the publications page of TG corporate website at View Source Following each presentation during ASH (Free ASH Whitepaper), the data presented will also be available on TG’s website.
ZOOM CONFERENCE CALL INFORMATION
The Company will host a zoom conference call November 5, 2020, at 8:45 AM ET.
In order to participate in the call, please join via the zoom webinar link: https://bit.ly/37XZai1, which will also be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source Attendees may also join via phone by dialing 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics ASH (Free ASH Whitepaper) Abstract Review Call. A recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.