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): June 3, 2017
TG Therapeutics, Inc.
(Exact Name of
Registrant as Specified in Charter)
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Delaware
(State or Other
Jurisdiction
of
Incorporation)
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001-32639
(Commission File
Number)
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36-3898269
(IRS Employer
Identification No.)
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2 Gansevoort Street, 9th
Floor
New York, New York 10014
(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:
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☐
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Written communications pursuant to Rule 425
under the Securities Act.
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☐
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Soliciting material pursuant to Rule 14a-12
under the Exchange Act.
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☐
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Pre-commencement communications pursuant to Rule
14d-2b under the Exchange Act.
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☐
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Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act.
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Indicate by check
mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (17 CFR
§230.405) or Rule 12b-2 of the Securities Exchange Act of 1934
(17 CFR §240.12b-2). Emerging growth company
☐
If an emerging
growth company, indicate by check mark if the registrant has
elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01. Other Events.
On June 3, 2017, TG
Therapeutics, Inc. (the “Company”) issued a press
release announcing positive results from its Phase 3 GENUINE trial
of TG-1101 (ublituximab) plus ibrutinib in patients with previously
treated high risk Chronic Lymphocytic Leukemia (CLL) presented in
an oral session during the 53rd American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago, IL. On June 5, 2017, the
Company announced updated clinical data from its ongoing Phase I/Ib
trial of TG-1101 (ublituximab) in combination with TGR-1202
(umbralisib) in patients with CLL and Non-Hodgkin’s Lymphoma
(NHL) presented during the 53rd ASCO Annual Meeting. Copies of the
press releases are being filed as Exhibits 99.1 and 99.2 and
incorporated in this Item by reference.
Item 9.01 Financial Statements And
Exhibits.
(d)
Exhibits.
99.1 Press
Release, dated June 3, 2017.
99.2 Press
Release, dated June 5, 2017.
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.
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TG Therapeutics, Inc.
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(Registrant)
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Date: June 5,
2017
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By: /s/
Sean A.
Power
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Sean A.
Power
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Chief Financial
Officer
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INDEX
TO EXHIBITS
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Exhibit
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Number
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Description
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99.1
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Press Release,
dated June 3, 2017.
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99.2
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Press Release, dated June 5,
2017.
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TG Therapeutics Announces Positive
Data from Phase 3 GENUINE Trial of TG-1101 in Combination with
Ibrutinib in Patients with High Risk Chronic Lymphocytic Leukemia
at the 53rd Annual Meeting of the American Society of
Clinical Oncology
Study met its primary endpoint with TG-1101 (ublituximab) plus
ibrutinib increasing Overall Response Rate (ORR) by >70% over
ibrutinib alone
TG-1101 plus ibrutinib achieved 78% ORR, with 7% Complete Responses
(CR), compared to 45% ORR with 0% CR’s for Ibrutinib Alone,
p<0.001 (median follow-up 11.4 months), with all responses now
confirmed as per iwCLL 2008 criteria
Combination of TG-1101 and ibrutinib resulted in 19% Minimal
Residual Disease (MRD) negativity compared to 2% for Ibrutinib
Alone, p<0.01
A trend in improvement of PFS was observed with the combination of
TG-1101 plus ibrutinib compared to ibrutinib alone (Hazard
Ratio=0.559; p=NS)
The combination was well tolerated and TG-1101 did not appear to
alter the safety profile of ibrutinib monotherapy, apart from
infusion related reactions associated with TG-1101 which were
primarily Grade 1/2
New York, NY, June 3, 2017 – TG Therapeutics
(NASDAQ: TGTX) today announced positive results from its Phase 3
GENUINE trial of TG-1101 (ublituximab) plus ibrutinib in patients
with previously treated high risk Chronic Lymphocytic Leukemia
(CLL). Data from this trial was presented today
by Dr.
Jeff Sharman, Medical Director, Hematology Research, US Oncology in
an oral session during the 53rd
American Society of Clinical Oncology
(ASCO) Annual Meeting in Chicago, IL.
Michael S. Weiss, Executive Chairman and Chief Executive Officer of
TG Therapeutics stated, “Patients with high-risk CLL have the
poorest outcomes on ibrutinib and are in need of a more efficacious
treatment. We believe the data presented today demonstrate that the
addition of TG-1101 to ibrutinib improves patient outcomes across
multiple measures.” Mr. Weiss continued, “In addition
to increasing the overall number of patients that responded to
treatment with ibrutinib, adding TG-1101 to ibrutinib increased the
number of patients with bone marrow confirmed CR’s, MRD
negativity in peripheral blood, deepened nodal responses, and
resulted in fewer patients progressing on therapy. Collectively, we
see the consistent pattern of enhanced benefit as providing a
compelling case for combining TG-1101 with ibrutinib in these hard
to treat patients with high-risk CLL. We look forward to sharing
these data with the FDA later this year to discuss filing for
accelerated approval. We would like to thank our investigators and
their patients for their participation in this important clinical
trial.”
Highlight’s from this presentation include the
following:
Oral Presentation: Ublituximab and ibrutinib for previously treated
genetically high-risk chronic lymphocytic leukemia: Results of the
GENUINE Phase 3 study
This
presentation includes data from the GENUINE Phase 3 trial, a
multicenter, randomized trial (NCT02301156), which assessed the
efficacy and safety of TG-1101 plus ibrutinib versus ibrutinib
alone in patients with high risk CLL. For the trial, high-risk was defined as having any
one or more of the following centrally confirmed features: 17p
deletion, 11q deletion or p53 mutation. The GENUINE study
was designed to demonstrate the value of adding TG-1101, a potent
next generation glycoengineered anti-CD20 monoclonal antibody to
ibrutinib monotherapy in high-risk CLL, and was powered to show a
statistically significant improvement in ORR of 30%, with a minimal
absolute detectable difference between the two arms of
approximately 20%.
The
trial met its primary endpoint, demonstrating a statistically
significant improvement in Overall Response Rate (ORR), as assessed
by blinded independent central radiology and hematology review
by iwCLL (Hallek 2008) criteria, compared to ibrutinib alone in
both the Intent to Treat (ITT) population (p=0.001) and Treated
population (p<0.001). Per iwCLL guidelines, all responders
required confirmation of response for a minimum duration of 2
months. The ITT population includes all 126 randomized patients (64
in the TG-1101 plus ibrutinib arm and 62 in the ibrutinib alone
arm) while the Treated population includes all ITT patients that
received at least one dose of either study drug (59 in the TG-1101
plus ibrutinib arm and 58 in the ibrutinib alone arm).
Patient Demographics
One
hundred and twenty-six (126) patients were randomized on the
GENUINE Phase 3 trial. 100% of patients were high-risk and had
either 17p deletion, 11q deletion, or p53 mutation. Sixty-four
percent (64%) of patients in the TG-1101 plus ibrutinib arm and 66%
of patients in the Ibrutinib alone arm had 17p deletion and/or a
p53 mutation while 36% and 34% of patients in the TG-1101 plus
ibrutinib and ibrutinib alone arms, respectively, had an 11q
deletion only. The median age of patients on either arm was 67
years and the median number of prior lines of therapy for either
arm was 3.
Safety & Tolerability
One hundred and seventeen (117) patients were evaluable for safety
(59 patients in the TG-1101 plus ibrutinib arm, and 58 patients in
the ibrutinib alone arm). The combination was well tolerated and,
apart from infusion related reactions, the addition of TG-1101 did
not appear to alter the safety profile of ibrutinib monotherapy.
Neutropenia, occurring in 9% of patients, was the most commonly
reported Grade 3/4 Adverse Event (AE) in the combination arm,
followed by infusion related reactions and anemia, each reported in
5% of patients. Notably, the majority of infusion related reactions
(IRR) were Grade 1 or 2 in severity, with only 5% Grade 3/4 IRR
observed. Median follow-up for this study was approximately 11.4
months.
Clinical Activity
Response Rates
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TG-1101
plus Ibrutinib
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Ibrutinib
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P-value
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Treated
Population (n)
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n=59
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n=58
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Overall
Response Rate (ORR)
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78%
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45%
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P<0.001
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Complete
Response (CR)
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7%
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0%
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NS
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MRD-Negative
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19%
(n=53) *
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2%
(n=53) *
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P<0.01
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*Patients evaluable for MRD included those enrolled >4 months
prior to data cutoff date of February 15, 2017. MRD analyzed by
central lab, 7-color flow cytometry
In
addition to the improvements in ORR, CR and MRD-negativity, a trend
in improvement of Progression Free Survival (PFS) was observed in
the combination arm of TG-1101 plus ibrutinib as compared to
ibrutinib alone (Hazard Ratio = 0.559; p=NS).
ABOUT THE PHASE 3 GENUINE STUDY
The Phase 3 GENUINE study is a randomized, open label, multicenter
clinical trial to evaluate the safety and efficacy of TG-1101
(ublituximab) plus ibrutinib compared to ibrutinib alone in adult
patients with high-risk Chronic Lymphocytic Leukemia (CLL) who
received at least one prior therapy for their disease.
The study was conducted at 160 clinical trial sites in the US and
Israel and randomized 126 patients. Patients received ibrutinib
orally at 420 mg once daily in both arms and in the combination arm
those patients also received intravenous infusions of TG-1101 at
900 mg dosed on days 1, 8 and 15 of cycle 1 and day 1 of cycles
2-6. Patients in the combination arm who had not progressed
received quarterly infusions of TG-1101 maintenance at 900
mg.
PRESENTATION DETAILS:
The
above referenced presentation isnow available on the Publications
page, located within the Pipeline section, of the Company’s
website at www.tgtherapeutics.com/publications.cfm.
TG THERAPEUTICS INVESTOR & ANALYST EVENT
TG
Therapeutics will host a reception on Monday, June 5, 2017
beginning at 7:00pm CT, with featured presentations beginning
promptly at 7:05pm CT. The event will take place at the Peninsula
Chicago Hotel in the Avenues Ballroom. 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. 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 June 2017
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 and autoimmune diseases. 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
(umbralisib), 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,
with TG-1101 also in clinical development for autoimmune disorders.
The Company also has pre-clinical programs to develop IRAK4
inhibitors, BET inhibitors, and 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 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. In addition to the risk
factors identified from time to time in our reports filed with
the Securities and Exchange Commission, factors that could
cause our actual results to differ materially are the following:
the risk that early clinical trial results, that may have supported
the acceptance of our data for presentation or influenced our
decision to proceed with additional clinical trials, will not be
reproduced in future studies;the risk that the FDA will not grant
us a pre-BLA meeting to discuss the results of the GENUINE study;
the risk that we will not file a BLA for TG-1101 based on the
GENUINE trial. 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
Vice President,
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com
TG Therapeutics, Inc. Announces
Follow-Up Data from the Chemo-Free Triple Combination of TG-1101,
TGR-1202, and Ibrutinib at the 53rd
Annual Meeting of the American Society
of Clinical Oncology
100% ORR (19 of 19) observed in patients with CLL/SLL, including
32% CR rate
100% ORR (6 of 6) observed in patients with MZL and MCL, with 50%
CR rate
80% ORR (4 of 5) observed in patients with FL, with 20% CR
rate
Favorable safety profile observed in patients treated with the
triple combination reinforcing that TG-1101 plus TGR-1202 is a
well-tolerated and efficacious backbone for multi-drug combination
regimens
CHICAGO, June 5, 2017-- TG Therapeutics, Inc. (NASDAQ: TGTX), today
announced updated clinical data from its ongoing Phase I/Ib trial
of TG-1101 (ublituximab), the Company’s novel glycoengineered
anti-CD20 monoclonal antibody in combination with TGR-1202
(umbralisib), the Company’s oral, next generation PI3K delta
inhibitor, and ibrutinib, a BTK inhibitor, in patients with Chronic
Lymphocytic Leukemia (CLL) and Non-Hodgkin’s Lymphoma (NHL).
Data from this trial was presented today during the 53rd American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
Additionally, a poster was presented describing the design of a
study evaluating TGR-1202 in CLL patients who are intolerant to
prior kinase inhibitor (KI) therapy, particularly ibrutinib and
idelalisib.
Michael S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “The triple data presented today
provides a compelling case for combining our doublet, referred to
as TG-1303, with ibrutinib across a number of b-cell malignancies
for which ibrutinib is now approved. Importantly, the high rates of
complete responses observed across these diseases with the triple
therapy may enable some patients to discontinue treatment prior to
becoming ibrutinib refractory, a population associated with very
poor outcomes.” Mr. Weiss continued, “Additionally, the
data shown today strengthens our belief that TG-1303 is a safe and
efficacious backbone upon which we can build triple and quad
therapies, as we continue to strive towards identifying
combinations that provide deeper remissions that can ideally avoid
lifetime treatment. We look forward to further exploring multi-drug
combination therapies both with currently approved agents as well
as with our in-house pipeline products.”
Highlights from today's presentations include the
following:
Poster
Presentation: Tolerability and
activity of chemo-free triplet combination of TGR-1202,
ublituximab, and ibrutinib in patients with advanced CLL and NHL
(Abstract #7511)
Poster Viewing
& Discussion Details: Monday, June 5, 2017 8:00 AM-11:30 AM CT (Poster
Viewing); 1:15 PM-2:30 PM CT (Poster
Discussion)
This poster presentation includes data from patients with Chronic
Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) and
Non-Hodgkin’s Lymphoma (NHL) treated with the triple
combination of TGR-1202, TG-1101 and ibrutinib. All patients were
relapsed or refractory to prior therapy, except 3 CLL patients who
were treatment naïve. Three cohorts for each CLL/SLL
and NHL were evaluated with TGR-1202 dose escalation
starting with doses of 400 mg (cohort 1), followed by 600 mg
(cohort 2) and 800 mg (cohort 3), in combination with TG-1101 at
900 mg and ibrutinib daily at 420 mg (CLL) and 560 mg
(NHL).
Safety & Tolerability
Thirty-eight (38) patients were evaluable for safety (20 CLL/SLL
patients, and 18 NHL patients). The triple combination appeared to
be well tolerated in all patients, with neutropenia (32% all
grades, 18% Grade 3/4) and pneumonia (18% all grades, 11% Grade
3/4), being the only Grade 3/4 AEs in >10% of patients. Of the
38 patients treated to date, only two AEs (sepsis and pneumonia)
led to treatment discontinuation. Median time on study was 11.1
months (range 0.4 – 30+ months) with 81% of patients on study
>6 months.
Clinical Activity
Clinical activity was observed at all dose levels with 36 of 38
patients evaluable for efficacy (19 CLL/SLL patients, and 17 NHL
patients), with 2 patients having discontinued prior to first
efficacy assessment (1 pneumonia, and 1 investigator
discretion).
CLL/SLL Efficacy highlights include:
●
100%
(19 of 19) Overall Response Rate (ORR), including a 32% Complete
Response (CR) rate observed in patients with CLL/SLL (4 of 6
CR’s pending bone marrow confirmation)
●
50%
of the CLL patients had a 17p and/or 11q deletion
●
3 CLL patients had
prior BTK and/or PI3Kd inhibitor therapy, including one patient refractory
to both idelalisib and ibrutinib who attained a complete response
(ongoing for 1.5+ years)
NHL Efficacy highlights include:
●
Response
Rates observed in patients with NHL:
o
100%
(2 of 2) ORR, including one CR in patients with Marginal Zone
Lymphoma (MZL)
o
100%
(4 of 4) ORR, including 50% CR rate in patients with Mantle Cell
Lymphoma (MCL)
o
80%
(4 of 5) ORR, including 20% CR rate in patients with Follicular
Lymphoma (FL)
o
17%
(1 of 6) ORR in patients with Diffuse Large B-cell Lymphoma
(DLBCL)
●
FL
patients were heavily pretreated including 2 with prior Autologous
Stem Cell Transplant (ASCT), 1 refractory to prior ibrutinib, and 1
with 5 prior lines of rituximab based therapy
●
DLBCL
patients had a median of 4 prior therapies, and 4 of 6 were of
non-GCB subtype
Poster
Presentation: KI
intolerance study: A phase 2 study to assess the safety and
efficacy of TGR-1202 in pts with chronic lymphocytic leukemia (CLL)
who are intolerant to prior BTK or PI3K-delta inhibitor therapy
(Abstract: TPS7569)
This
poster details the study design for an ongoing Phase II,
multicenter, single-arm trial of TGR-1202 (umbralisib) in CLL
patients requiring therapy who are intolerant to prior Kinase
Inhibitor (KI) therapy. The study will enroll approximately 50
patients who have discontinued prior therapy with a BTK or PI3K
delta inhibitor due to intolerance and not disease progression. The
primary objective of the study is to determine the progression free
survival (PFS) of TGR-1202 in this patient population. Key
secondary objectives such as overall response rate, duration of
response, time to treatment failure and safety of TGR-1202 as
compared to the prior KI therapy will also be
evaluated.
PRESENTATION DETAILS:
The
above referenced presentations are now available on the
Publications page, located within the Pipeline section, of the
Company’s website at
www.tgtherapeutics.com/publications.cfm.
TG THERAPEUTICS INVESTOR & ANALYST EVENT
TG
Therapeutics will host a reception tonight, Monday, June 5, 2017
beginning at 7:00pm CT, with featured presentations beginning
promptly at 7:05pm CT. The event will take place at the Peninsula
Chicago Hotel in the Avenues Ballroom. 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. 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 June 2017
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 and autoimmune diseases. 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 (umbralisib), 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, with TG-1101 also in clinical development for
autoimmune disorders. The Company also has pre-clinical programs to
develop IRAK4 inhibitors, BET inhibitors, and 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 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. In addition
to the risk factors identified from time to time in our reports
filed with the Securities and Exchange Commission, factors
that could cause our actual results to differ materially are the
following: our ability to successfully and cost effectively
complete preclinical and clinical trials; the risk that early
clinical trial results, that may have supported the acceptance of
our data for presentation or influenced our decision to proceed
with additional clinical trials, will not be reproduced in future
studies; the risk that the combination of TG-1101 and TGR-1202,
referred to as TG-1303 and being studied in the chemo-free triple
combination of TG-1101 plus TGR-1202 plus ibrutinib and in the
UNITY clinical trials and other combination trials, will not prove
to be safe and efficacious for any indication or as a backbone for
current or future triple and/or quad therapies; the risk that even
if the company is successful in developing its drugs through FDA
approval and on to the market, that the cost efficiencies
anticipated through proprietary combinations may not be realized in
the marketplace. 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
Vice President,
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com