On November 05, 2015 TG Therapeutics, Inc. (Nasdaq:TGTX) reported that updated data for TG-1101 (ublituximab), the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, and TGR-1202, the Company’s next generation PI3K delta inhibitor, has been selected for presentation at the upcoming 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper), to be held December 5-8, 2015, at the Orange County Convention Center in Orlando, Florida (Press release, TG Therapeutics, NOV 5, 2015, View Source [SID:1234507999]).
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Michael S. Weiss, Executive Chairman and Interim Chief Executive Officer of TG Therapeutics, stated "We are very excited to be able to provide updates on our key Phase 1 and 2 clinical studies for TG-1101 and TGR-1202 at the upcoming ASH (Free ASH Whitepaper) conference. With patients now on once-daily TGR-1202 for durations of over 2.5 years, we and our investigators continue to believe that TGR-1202 has a differentiated safety profile in comparison to other PI3K delta inhibitors and continues to pair nicely with TG-1101 in our proprietary "TG-1303" regimen, which we believe exhibits best-in-class attributes that not only supports our recently announced Phase 3 UNITY-CLL study, but provides a safe and highly active backbone for building novel triple and potentially quad therapies. We are also excited to report data from the first triple therapy of TGR-1202 plus chemotherapy plus a glycoengineered anti-CD20 monoclonal antibody (obinutuzumab) which appeared to be well tolerated with a high level of activity in both front-line CLL patients and patients refractory to BTK inhibitors. We believe these data further support our UNITY-CLL study and also provide a nice comparison to TG-1303, especially from a safety standpoint. Finally, there will be one pre-clinical oral presentation that elucidates a very novel and exciting mechanism of TGR-1202, that is unique to TGR-1202 as opposed to other PI3K delta inhibitors and could have broad ranging implications for certain combinations in both liquid and solid tumors," stated Michael S. Weiss, the Company’s Executive Chairman and Interim CEO. He continued, "We are looking forward to sharing the full datasets for these presentations in a few weeks, which will contain more detailed data and additional patients than included in the abstracts."
Presentations on TG-1101 and TGR-1202 at the ASH (Free ASH Whitepaper) meeting include the following:
Clinical Posters:
Title: Ublituximab + TGR-1202 Demonstrates Activity and Favorable Safety Profile in Relapsed/Refractory B-Cell NHL and High-Risk CLL: Phase I Results
Abstract Number: 1538
Session: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster I
Date and Time: Saturday, December 5, 2015; 5:30 PM- 7:30 PM ET
Location: Orange County Convention Center, Hall A
Presenter: Matthew Lunning, DO
Title: A Phase I Trial of TGR-1202, a Next Generation Once Daily PI3K-Delta Inhibitor in Combination with Obinutuzumab Plus Chlorambucil, in Patients with Chronic Lymphocytic Leukemia
Abstract Number: 2942
Session: 642. CLL: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 6, 2015; 6:00 PM-8:00 PM ET
Location: Orange County Convention Center, Hall A
Presenter: Daruka Mahadevan, MD, PhD
Title: Ublituximab (TG-1101), A Novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Combination With Ibrutinib is Highly Active in Patients With Relapsed And/Or Refractory Mantle Cell Lymphoma; Results of a Phase II Trial
Abstract Number: 3980
Session: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster III
Date and Time: Monday, December 7, 2015; 6:00 PM- 8:00 PM ET
Location: Orange County Convention Center, Hall A
Presenter: Kathryn Kolibaba, MD
Title: TGR-1202, a Novel Once Daily PI3K-Delta Inhibitor, Demonstrates Clinical Activity with a Favorable Safety Profile in Patients with CLL and B-Cell Lymphoma
Abstract Number: 4154
Session: 642. CLL: Therapy, excluding Transplantation: Poster III
Date and Time: Monday, December 7, 2015; 6:00 PM- 8:00 PM ET
Location: Orange County Convention Center, Hall A
Presenter: Owen O’Connor, MD, PhD
Non-Clinical Oral Presentation:
Title: Disruption of the mTOR-eIF4F Axis By Selectively Targeting PI3Kdelta and Proteasome Potently Inhibits Cap Dependent Translation of c-Myc in Aggressive Lymphomas
Abstract Number: 593
Oral Session: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Novel Therapies and Targets in Lymphoma
Date and Time: Monday, December 7, 2015; 10:30 AM – 12:00 PM ET
Presentation Time: 11:30 AM ET
Location: Orange County Convention Center, Tangerine 1 (WF1)
Presenter: Changchun Deng, MD, PhD
A copy of the above referenced abstracts can be viewed online through the ASH (Free ASH Whitepaper) meeting website at www.hematology.org.
TG Therapeutics will also host a reception on Monday, December 7th, 2015 beginning at 7:45pm ET, with featured presentations beginning promptly at 8:00pm ET. The event will take place at the Hyatt Regency Orlando. This event will be webcast live and will be available on the Events page, under the Investors & Media tab, of the Company’s website at www.tgtherapeutics.com.