UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_____________
FORM 8-K
_____________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): December 6, 2015
TG Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
|
Delaware (State or Other Jurisdiction of Incorporation) |
001-32639 (Commission File Number)
|
36-3898269 (IRS Employer Identification No.) |
3 Columbus Circle, 15th Floor
New York, New York 10019
(Address of Principal Executive Offices)
(212) 554-4484
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act. |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act. |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act. |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. |
Item 8.01. Other Events.
On December 6, and December 7, 2015, TG Therapeutics, Inc. issued press releases announcing certain data regarding its clinical studies of TG-1101 in combination with TGR-1202, TGR-1202 in combination with obinutuzumab, TGR-1202 as a single agent, and a pre-clinical data presentation on the combination of TGR-1202 and proteasome inhibitors, respectively. Copies of the press releases are being filed as Exhibits 99.1, 99.2 and 99.3 and incorporated in this Item by reference.
Item 9.01 Financial Statements And Exhibits.
| (d) | Exhibits. |
| 99.1 | Press Release, dated December 6, 2015. |
| 99.2 | Press Release, dated December 7, 2015. |
| 99.3 | Press Release, dated December 7, 2015. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
TG Therapeutics, Inc.
(Registrant)
Date: December 7, 2015
By: /s/ Sean A. Power__________
Sean A. Power
Chief Financial Officer
INDEX TO EXHIBITS
| Exhibit | |
| Number | Description |
| 99.1 | Press Release, dated December 6, 2015. |
| 99.2 | Press Release, dated December 7, 2015. |
| 99.3 | Press Release, dated December 7, 2015. |
Exhibit 99.1
TG Therapeutics, Inc. Announces Data Presentations at the 57th American Society of Hematology Annual Meeting From Ongoing Clinical Studies in Patients with Non-Hodgkins Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
Combination of TG-1101 plus TGR-1202 (“TG-1303”) continues to demonstrate a favorable safety profile, with only 8% of patients discontinuing due to an adverse event and no cases of colitis reported to date
80% (8 of 10) ORR in patients with relapsed refractory CLL/SLL treated in the higher dose cohort of TG-1303, including 1 CR and 7 PR’s and the remaining 2 patients with stable disease, one still on study with significant reduction in tumor burden (CLL evaluated per iwCLL 2008 criteria)
71% (12 of 17) ORR, including 24% CRs, in patients with heavily pretreated relapsed/refractory Follicular Lymphoma (FL) & Marginal Zone Lymphoma (MZL) treated in the higher dose cohort of TG-1303
35% (6 of 17) ORR in patients with relapsed/refractory DLBCL and Richter’s transformation (large cell lymphoma) treated in the higher dose cohort of TG-1303
TGR-1202 based combination therapy with the glycoengineered
anti-CD20 mAb, obinutuzumab, plus chlorambucil achieved 100% (15 of 15) ORR in treatment naïve CLL patients, with 33% of patients
achieving a CR, and 47% of patients achieving MRD negativity
ORLANDO, FL, December 6, 2015-- TG Therapeutics, Inc. (Nasdaq:TGTX), today announced updated clinical results from its ongoing Phase I proprietary combination study of TG-1101 (ublituximab), the Company’s novel, glycoengineered monoclonal antibody and TGR-1202, the Company's oral, once-daily, PI3K delta inhibitor as well as data from the Phase I study of TGR-1202 in combination with obinutuzumab plus chlorambucil. Data from these Phase I studies were presented this weekend at poster sessions during the 57th American Society of Hematology (ASH) Annual Meeting and Exposition being held at the Orange County Convention Center in Orlando, FL.
Michael S. Weiss, the Company’s Executive Chairman and Interim CEO commented on the data, “We and our clinical investigators continue to be impressed with the activity and safety profile of our proprietary TG-1303 regimen with almost all CLL patients responding and over 70% of heavily pre-treated patients with indolent lymphoma responding to 1303. We are also very excited by the data in patients with large cell lymphoma where we are seeing 35% response rates in heavily pre-treated patients. Collectively, we believe these data support advanced clinical studies for TG-1303 across CLL and NHL and, accordingly, we plan to expand our UNITY clinical program into NHL in 2016. Finally, we are excited to see the high level of activity of a TGR-1202 based regimen in front-line CLL. We believe the safety and efficacy profile observed in those front-line patients sets the stage for what we should expect to see from TG-1303 in front-line patients included in our UNITY-CLL Phase 3 trial, which should open for enrollment in the coming weeks.” Mr. Weiss continued, “We appreciate the strong support of our clinical investigators and thank them and their patients for participating in these important clinical trials.”
Dr. Matthew Lunning, Assistant Professor, Division of Hematology at the University of Nebraska Medical Center and lead author for the poster presentation stated, “The principal goal for any novel-novel combination study is to establish safety and combinability of two agents. With the combination of ublituximab and TGR-1202, patients were not only able to achieve high response rates and durable remissions, but most importantly, were able to stay on treatment with limited discontinuations due to adverse events, which has been commonly seen with other novel targeted agents in this class. Many of the patients enrolled onto this study have been heavily pre-treated with limited treatment options, especially patients with DLBCL, and the ability to offer patients a novel-novel combination which has the potential to extend and improve patient lives is of great excitement.”
The following summarizes the posters presented this weekend:
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)
This poster was presented yesterday, Saturday December 5th during the ASH Annual Meeting and included data from patients with relapsed and refractory NHL and high-risk CLL treated with the combination of TG-1101 (ublituximab) and TGR-1202. The combination has been well tolerated in the 71 patients evaluable for safety at all dose levels up through 1200mg micronized. This was a heavily pretreated population with high-risk features, including 58% refractory to last treatment with multiple previous lines of rituximab based therapy. Efficacy data was presented on patients treated at the higher doses of TGR-1202 (1200mg of the original formulation and 600mg or greater of the micronized formulation).
Highlights from this poster include:
| · | 80% (8 of 10) ORR in patients with CLL/SLL, including 1 CR and 7 PRs |
| o | Remaining 2 patients had stable disease, one of which remains on study and the other, an ibrutinib refractory patient, progressed after 2 cycles |
| o | 75% of CLL patients had high-risk cytogenetics (17p and/or 11q del) |
| o | Data supports the current Phase 3 UNITY-CLL Study of TG-1101 + TGR-1202 in CLL |
| · | 71% (12 of 17) ORR in heavily pretreated patients with indolent NHL (FL & MZL), including 4 CRs (24%) and 8 PRs, with 4 of the remaining 5 patients achieving stable disease |
| · | 35% (6 of 17) ORR in patients with DLBCL and Richter’s Transformation, 3 of which achieved a CR, with 2 additional patients achieving stable disease |
| o | 94% of DLBCL patients were refractory to prior therapy with 69% of patients rituximab refractory, including one patient with triple hit lymphoma |
| o | Of the 16 DLBCL patients, 9 were GCB subtype, 3 were ABC subtype, and 4 patients’ subtype was unknown, with notable activity (ORR and PFS) observed in patients with confirmed GCB subtype |
| · | Combination of 1303 was well tolerated, with only 8% of patients discontinuing due to an adverse event: |
| o | Notably, the only Grade 3/4 adverse event occurring in >5% of patients was neutropenia. Of the 71 patients available for safety, only 6 patients (8%) discontinued due to a TGR-1202 related event |
| o | Twenty-six patients have been on the combination of TG-1101 plus TGR-1202 for 6+ months, with no events of colitis reported to date |
| o | Safety profile supports multi-drug regimens |
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)
The poster was presented today, Sunday December 6th during the ASH Annual Meeting and includes data from patients with treatment naïve and previously treated CLL treated with TGR-1202 in combination with the glycoengineered anti-CD20 mAb, obinutuzumab, and chlorambucil. The study design evaluated escalating doses of TGR-1202 which was dosed orally once-daily starting at Day 1 of Cycle 1. Obinutuzumab and chlorambucil were administered according to their FDA labeled dosing regimen. The combination was dosed in 18 patients, of which 15 were treatment naïve and 3 were previously treated. All patients were evaluable for safety and efficacy.
Highlights from this poster include:
| · | 100% (15 of 15) ORR in treatment naïve CLL patients, with 33% of patients achieving a CR, and 47% of patients achieving MRD negativity |
| · | 95% (17 of 18) ORR in treatment naïve and relapsed/refractory CLL patients, with 28% of patients achieving a CR |
| o | Remaining patient achieved a 45% nodal reduction and remains on study, progression-free |
| o | Notably, all previously treated CLL patients were refractory to a prior BTK inhibitor and had at least one high-risk cytogenetic abnormality |
| · | The combination demonstrated acceptable tolerability, which notably differed from that observed when TGR-1202 was combined with TG-1101 in patients with relapsed or refractory CLL, specifically regarding neutropenia (78% vs. 30%), thrombocytopenia (78% vs. <10%), and transaminase elevations (39% vs. 8%) |
| · | The median PFS has not been reached, with the longest patient on study now 20+ months on TGR-1202 daily maintenance at 800mg |
POSTER Presentation details
A copy of the poster presentations are available on the Company’s website at www.tgtherapeutics.com, located on the Publications Page, within the Pipeline section.
TG THERAPEUTICS INVESTOR & ANALYST EVENT DETAILS
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 in the Bayhill 17/18 Room. This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review. This event will also be broadcast via conference call. In order to access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics 2015 Investor & Analyst Event.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the Company is developing two therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. The Company also has a pre-clinical program to develop IRAK4 inhibitors, as well as an antibody research program to develop anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
TGTX-G
| CONTACT: | Jenna Bosco |
| Director- Investor Relations | |
| TG Therapeutics, Inc. | |
| Telephone: 212.554.4351 | |
| Email: ir@tgtxinc.com |
Exhibit 99.2
TG Therapeutics, Inc. Announces Data Presentations for TGR-1202 and TG-1101 in Combination with Ibrutinib at the 57th American Society of Hematology Annual Meeting
Single agent TGR-1202 continues to demonstrate a favorable safety profile, differentiated from other PI3K delta inhibitors, with only 7% of patients discontinuing due to an adverse event
Collectively, aggregated from all data presentations at ASH 2015, over 80 patients have been on TGR-1202 for greater than 6 months and 42 patients have been on TGR-1202 for over 1 year, with no cases of colitis being reported
94% (16 of 17) of CLL patients treated with TGR-1202 single agent achieved a nodal PR, with the remaining patient still on study pending further evaluation
75% (12 of 16) of Follicular Lymphoma (FL) patients demonstrated tumor reductions, with a preliminary ORR of 38% (6 of 16), with 2 additional patients achieving 49% reductions in tumor burden and continuing on study
Combination of TG-1101 and ibrutinib resulted in an 87% (13 of 15) ORR in patients with relapsed or refractory Mantle Cell Lymphoma (MCL), including a 33% CR rate
ORLANDO, FL, December 7, 2015-- TG Therapeutics, Inc. (Nasdaq:TGTX), today announced the presentation of updated clinical results from its ongoing Phase I single agent study of TGR-1202, the Company’s next generation PI3K delta inhibitor, as well as its Phase II combination study of TG-1101 (ublituximab), the Company’s novel, glycoengineered monoclonal antibody plus ibrutinib, the oral BTK inhibitor. Data from these studies are being presented today, Monday December 7, 2015 at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition being held at the Orange County Convention Center in Orlando, FL.
Michael S. Weiss, the Company’s Executive Chairman and Interim CEO commented on the data, “We are extremely pleased that the activity and safety profile of TGR-1202 continues to exhibit best in class attributes. As a once daily PI3K delta inhibitor, we believe the added convenience along with a low occurrence of hepatic toxicity, will make TGR-1202 a very appealing treatment option for physicians. More importantly, with over 80 patients having been exposed to TGR-1202 for over 6 months and another 42 on drug for more than a year, we believe the data supports that colitis associated with other PI3K deltas is not likely to be a major concern for TGR-1202. We are also excited about the final data from our 1101 plus ibrutinib study in patients with advanced Mantle Cell Lymphoma. More and more, physicians are recognizing the need to deepen ibrutinib responses to avoid relapse and the data demonstrating a doubling of CRs in patients with MCL compared to historical data of single agent ibrutinib seems very encouraging, although in a small number of patients. The deepening of responses in MCL, primarily a nodal disease, is further confirmation of the ability of TG-1101 to penetrate the nodes and improve responses. This is consistent with the deepening of responses seen with the combination in CLL, where we reported 25% CR and/or MRD negativity in rel/ref CLL, which compares favorably to the ibrutinib label. We believe this is further confirmation of the benefit we expect to see in our GENUINE Phase 3 trial.”
Dr. Owen A. O’Connor, Professor of Medicine and the Director of the Center for Lymphoid Malignancies, at the Columbia University Medical Center and lead author for the TGR-1202 single agent poster presentation stated, “With many patients on daily TGR-1202 now for well over a year, and upwards of 2.5 years, we are very impressed with the continued tolerability and long term safety profile of TGR-1202, which we believe is truly differentiated from other PI3K delta inhibitors. Discontinuations due to adverse events have been particularly rare, translating into prolonged progression-free survival in relapsed and refractory CLL and indolent NHL patients of two years or more. We are excited at the potential to bring forward this important and needed treatment option for patients with advanced hematologic malignancies.”
The following summarizes the posters presented today:
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)
This poster presentation includes data from patients with relapsed and refractory Chronic Lymphocytic Leukemia (CLL) and B-Cell lymphoma (NHL and Hodgkin’s) treated with TGR-1202 as a single agent. Eighty-one patients were evaluable for safety, and 63 patients evaluable for efficacy, which includes patients treated with 800 mg of the initial formulation or higher, and any micronized dose level. Patients in this study were heavily pretreated with 57% of patients having seen ≥ 3 prior therapies, and 49% of patients being refractory to their prior therapy.
Highlights from this poster include:
| · | 94% (16 of 17) of CLL patients achieved a nodal PR, with the remaining patient still on study pending further evaluation |
| · | 59% (10 of 17) of these CLL patients achieved a response per the iwCLL (Hallek 2008) criteria |
| · | Median progression free survival (PFS) in the CLL cohort was approximately 24 months |
| · | 75% (12 of 16) of follicular lymphoma patients demonstrated tumor reductions, with a preliminary ORR of 38% (6 of 16), with 2 additional patients achieving 49% reductions in tumor burden, each continuing on study pending further efficacy assessments |
| · | Median PFS for the indolent NHL cohort was 27.3 months |
| · | TGR-1202 continues to demonstrate a favorable safety profile, differentiated from the other PI3K deltas inhibitors, with only 7% of patients discontinuing due to an adverse event |
| · | Limited grade 3/4 adverse events were reported with anemia and neutropenia (each 9%) being the only grade 3/4 adverse events reported in greater than 5% of patients |
| · | Long-term safety has been well characterized with 47% (38 of 81) of patients on study more than 6 months, 27% (22 of 81) of patients on study more than 12 months, and the longest exposed to drug for more than 2.5 years |
| · | No events of colitis have been reported, and grade 3/4 AST/ALT elevations have been seen in 2% of patients (4% all grades) |
| · | Safety and efficacy profile supports combination therapy with other novel targeted agents |
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)
This poster presentation includes data from 15 patients with previously treated mantle cell lymphoma (MCL) treated with 900mg of TG-1101, in combination with ibrutinib at an oral daily dose of 560mg. There was no limit on prior type or number of therapies and patients previously treated with prior with a BTK inhibitor and/or a PI3K delta inhibitor were permitted. The combination appeared well tolerated in all patients treated, with neutropenia being the only reported grade 3/4 adverse event occurring in greater than 7% of patients and no infusion related reactions being reported for TG-1101.
Highlights from this poster include:
| · | 87% (13 of 15) investigator assessed ORR, including a 33% Complete Response rate which compares favorably to historical single agent ibrutinib data (66% investigator assessed ORR and 17% CR) |
| · | 93% (14 of 15) of patients achieved some reduction in tumor burden on study, with the remaining patient having been refractory to prior anti-CD20 therapy and refractory to prior ibrutinib therapy progressing in Cycle 3 |
| · | Greater depth of response was achieved over time, with a 62% median reduction in tumor burden at week 8 which increased to a 76% median reduction by week 20 |
| · | No dose reductions were needed for TG-1101, however 20% (3 of 15) of patients had their ibrutinib dose reduced. |
POSTER Presentation details
A copy of the poster presentations are available on the Company’s website at www.tgtherapeutics.com, located on the Publications Page, within the Pipeline section.
TG THERAPEUTICS INVESTOR & ANALYST EVENT DETAILS
TG Therapeutics will also host a reception this evening, 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 in the Bayhill 17/18 Room. This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review. This event will also be broadcast via conference call. In order to access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics 2015 Investor & Analyst Event.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the Company is developing two therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-lymphocytes. Both TG-1101 and TGR-1202, alone and in combination with each other (when combined referred to as “TG-1303”), are in clinical development for patients with hematologic malignancies. The Company also has a pre-clinical program to develop IRAK4 inhibitors, as well as an antibody research program to develop anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and possible success of those trials and business prospects for TG-1101, TGR-1202, TG-1303, the IRAK4 inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101, TGR-1202, TG-1303, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, TG-1303, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 and TG-1303 will not continue, the risk that TGR-1202 or TG-1303 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 studies; the risk that the combination of TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
TGTX-G
| CONTACT: | Jenna Bosco |
| Director- Investor Relations | |
| TG Therapeutics, Inc. | |
| Telephone: 212.554.4351 | |
| Email: ir@tgtxinc.com |
Exhibit 99.3
TG Therapeutics, Inc. Announces Oral Presentation of Novel Pre-Clinical Combinations with TGR-1202 by Investigators at Columbia University at the 57th American Society of Hematology Annual Meeting
TGR-1202 combinations uniquely able to modulate c-Myc activity, with significant potential in the treatment of Diffuse-Large B-Cell Lymphoma and other malignancies
ORLANDO, FL, December 7, 2015-- TG Therapeutics, Inc. (Nasdaq:TGTX), today announced the presentation of pre-clinical data describing the synergy of the Company’s next generation PI3K-delta inhibitor, TGR-1202, with proteasome inhibitors in various hematologic cell lines and patient donor cells. The oral presentation was delivered by Changchun Deng, MD, PhD, Assistant Professor, Center of Lymphoid Malignancies, Columbia University Medical Center at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition being held at the Orange County Convention Center in Orlando, FL.
Combination data was generated using TGR-1202, the PI3k-delta inhibitor idelalisib, and the proteasome inhibitors carfilzomib and bortezomib. Data revealed that the combination of TGR-1202 and carfilzomib was uniquely synergistic as compared to any other combination of a PI3K-delta inhibitor and proteasome inhibitor, including the combination of idelalisib and cafilzomib and idelalisib and bortezomib. These data were generated as part of a large pre-clinical research collaboration with the Center for Lymphoid Malignancies, whereby the activity and mechanism of action of TGR-1202 is being studied in a variety of in-vitro and in-vivo models.
Presently there are no agents approved that specifically target c-Myc, an oncogene often found constitutively active in a variety of cancers, including Diffuse Large B-Cell Lymphoma, and has recently been the target of a class of drugs knows as BET (bromodomain and extraterminal domain family) inhibitors. The combination of TGR-1202 and carfilzomib was found to potently inhibit cap dependent translation of c-Myc in all cell lines tested, including DLBCL, mantle cell lymphoma, multiple myeloma, T-cell lymphoma, and CLL cells. In these cell lines, inhibition of c-Myc expression resulted in increased caspase 3/7 activity and complete cleavage of PARP, both mechanisms of apoptosis. Importantly, the combination was not found to be cytotoxic when evaluated on healthy patient lymphocytes indicating the specificity towards malignant cells. As a result of these data, the combination of TGR-1202 and carfilzomib is intended to be studied in a Phase I/II clinical trial to be led by investigators at Columbia University Medical Center.
Commenting on the data, Owen A. O’Connor, MD, PhD, Professor of Medicine and Experimental Therapeutics, and Director of the Center for Lymphoid Malignancies at Columbia University Medical Center stated, “The development of agents that have the ability to inhibit the expression or activity of c-Myc, a key driver in a large variety of hematologic and solid-tumor malignancies, has long been an area of focused research which to date has yielded modest results. The potential for this unique combination is far reaching, and begins to explain the differentiated pharmacologic profile demonstrated by TGR-1202 in patients. We look forward to continuing to elucidate the mechanisms for TGR-1202’s unique tolerability and efficacy, as well as evaluating this combination in patients in our upcoming Phase I/II study.”
Michael S. Weiss, the Company’s Executive Chairman and Interim CEO stated, “TGR-1202 has demonstrated strong activity with a differentiated safety and tolerability profile in patients across a variety of clinical trials, and we are eager to explore and understand the mechanisms that contribute to TGR-1202’s potential best-in-class attributes. We thank the investigators at Columbia University, especially Dr. Deng and Dr. O’Connor, for all their efforts on this important research program.”
Presentation details
A copy of the slides used for the oral presentation is available on the Company’s website at www.tgtherapeutics.com, located on the Publications Page, within the Pipeline section.
TG THERAPEUTICS INVESTOR & ANALYST EVENT DETAILS
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 in the Bayhill 17/18 Room. This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review. This event will also be broadcast via conference call. In order to access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics 2015 Investor & Analyst Event.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the Company is developing two therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-lymphocytes. Both TG-1101 and TGR-1202, alone and in combination with each other (when combined referred to as “TG-1303”), are in clinical development for patients with hematologic malignancies. The Company also has a pre-clinical program to develop IRAK4 inhibitors, as well as an antibody research program to develop anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and possible success of those trials and business prospects for TG-1101, TGR-1202, TG-1303, the IRAK4 inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101, TGR-1202, TG-1303, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical and clinical results particularly pre-clinical combinations with TGR-1202 that supported our decision to move forward with TG-1101, TGR-1202, TG-1303, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 and TG-1303 will not continue, the risk that TGR-1202 or TG-1303 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 studies; the risk that the combination of TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
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| CONTACT: | Jenna Bosco |
| Director- Investor Relations | |
| TG Therapeutics, Inc. | |
| Telephone: 212.554.4351 | |
| Email: ir@tgtxinc.com |