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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): September 20, 2023
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
delaware |
|
001-39717 |
|
20-2903526 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(I.R.S.
Employer
Identification
Number) |
680
East Colorado Boulevard, Suite 180
Pasadena
California 91101
(Address
of principal executive offices)
(631)
830-7092
(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 (See General Instruction A.2. below):
☐ | Written
communications pursuant to Rule 425 under the Securities Act of 1933 (17 CFR 230.425) |
| |
☐ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
☐ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
☐ | Pre-commencement
communications pursuant to Rule 13e-4(e) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.0001 per share |
|
LIXT |
|
The
NASDAQ Stock Market, LLC |
Warrants
to Purchase Common Stock, par value $0.0001 per share |
|
LIXTW |
|
The
NASDAQ Stock Market, LLC |
On
September 20, 2023, the Company issued a press release regarding a Phase 1b collaborative trial to be conducted at the University of
Texas MD Anderson Cancer Center to assess whether adding LB-100, the Company’s lead compound, to GSK’s Dostarlimab
enhances the effectiveness in the treatment of ovarian clear cell carcinoma.
Item
9.01. | Financial
Statements and Exhibits. |
(d)
There is filed as part of this report the exhibit listed on the accompanying Index to Exhibits, which exhibit is incorporated herein
by reference.
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.
Date:
September 20, 2023 |
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
|
|
|
|
|
By: |
/s/
JOHN S. KOVACH |
|
|
John S. Kovach, Chief Executive Officer
|
INDEX
TO EXHIBITS
EXHIBIT
99.1
LIXTE
Biotechnology Announces a Supported Collaborative Trial to Study LIXTE’s First-in-Class PP2A Inhibitor, LB-100, Plus GSK’s
Immunotherapy, Dostarlimab, in Clear-Cell Ovarian Cancer
The
Phase 1b Clinical Trial Focuses on Assessing the Safety and Efficacy of the Two-Drug Combination in a Cancer Associated with Longer Survival
to Immunotherapy When Genetically Deficient in PP2A
PASADENA,
CA, September 20, 2023 — LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) (“LIXTE”), today announced
a Phase 1b collaborative clinical trial to assess whether adding Lixte’s LB-100 to GSK’s programmed death receptor-1 (PD-1)-blocking
monoclonal antibody, dostarlimab, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (OCCC).
The clinical trial is sponsored by The University of Texas MD Anderson Cancer Center and will be conducted at MD Anderson and will
also be open at Northwestern University’s Robert H. Lurie Comprehensive Cancer Center. LIXTE will provide LB-100; GSK will provide
dostarlimab and financial support for the clinical trial.
The
clinical trial is based on the observation of longer survival of patients with OCCC treated with immunotherapy whose cancer cells have
an acquired gene mutation resulting in a reduction in PP2A. This finding was reported by the lead clinical investigators of this new
trial1: Amir Jazaeri MD, Professor of Gynecologic Oncology at MD Anderson, and Emily Hinchcliff, MD, MPH, Assistant Professor
of Obstetrics and Gynecology at Northwestern University Feinberg School of Medicine. The observation by Drs. Jazaeri and Hinchcliff,
that a genetically acquired reduction in PP2A enhances sensitivity to immunotherapy, raises the possibility that reducing PP2A pharmacologically
with LB-100 will enhance the anti-tumor effect of the PD-1 blocking monoclonal antibody dostarlimab in patients with OCCC lacking the
genetic reduction in PP2A.
John
S. Kovach, M.D., LIXTE’s founder and Chief Executive Officer, said, “Preclinical data supports the idea that LB-100 enhances
the efficacy of PD-1 therapy.1 Clinical data also supports this idea, in that patients with ovarian clear cell carcinoma
with dysfunctional PP2A due to somatic mutations in PPP2R1A have shown dramatically longer survival after treatment with immune checkpoint
blockers”.
Dr.
Hinchcliff, said, “OCCC is a comparatively chemotherapy resistant disease and therefore has very limited options for treatment.
This clinical trial is an exciting alternative approach that leverages the potential synergy between these two agents and is aiming to
improve the impact immunotherapy may have for these patients.”
1
Hinchcliff EM, Patel A, Fellman B, Westin SN, Sood A, Soliman P, Shafer A, Meyer L, Fleming N, Bathala Y, Ganeshan D, Hwu
P, Lu K, Jazaeri A. Loss-of-function mutations in PPP2R1A Correlate with Exceptional Survival in Ovarian Clear Cell Carcinomas
Treated with Immune Checkpoint Inhibitors. National oral presentation at SGO Annual Meeting, March 2022
About
LIXTE Biotechnology Holdings, Inc.
LIXTE
Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on new targets for cancer drug development and developing
and commercializing cancer therapies. LIXTE has achieved a breakthrough demonstrating that its first-in-class lead clinical PP2A inhibitor,
LB-100, is well-tolerated in cancer patients at doses associated with anti-cancer activity. Based on extensive published preclinical
data (see www.lixte.com), LB-100 has the potential to significantly improve outcomes for patients undergoing various chemotherapies
or immunotherapies. LIXTE’s new approach has no known competitors and is covered by a comprehensive patent portfolio. Initial proof-of-concept
clinical trials are in progress.
Forward-Looking
Statement Disclaimer
This
announcement contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section
21E of the Securities Exchange Act of 1934. For example, statements regarding the Company’s financial position, business strategy
and other plans and objectives for future operations, and assumptions and predictions about future activities, including the continuing
development of proprietary compounds, the planning, funding, coordination and potential results of clinical trials, the patent and legal
costs to protect and maintain the Company’s intellectual property worldwide, and the Company’s ability to obtain and maintain
compliance with Nasdaq’s continued listing requirements, are all forward-looking statements. These statements are generally accompanied
by words such as “intend,” anticipate,” “believe,” “estimate,” “potential(ly),”
“continue,” “forecast,” “predict,” “plan,” “may,” “will,” “could,”
“would,” “should,” “expect” or the negative of such terms or other comparable terminology.
The
Company believes that the assumptions and expectations reflected in such forward-looking statements are reasonable, based on information
available to it on the date hereof, but the Company cannot provide assurances that these assumptions and expectations will prove to have
been correct or that the Company will take any action that the Company may presently be planning. However, these forward-looking statements
are inherently subject to known and unknown risks and uncertainties. Actual results or experience may differ materially from those expected
or anticipated in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited
to, regulatory policies, available cash resources, research results, competition from other similar businesses, and market and general
economic factors.
Readers
are urged to read the risk factors set forth in the Company’s filings with the United States Securities and Exchange Commission
at https://www.sec.gov. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether
as a result of new information, future events or otherwise.
For
more information about LIXTE, Contact: info@lixte.com
General
Phone: (631) 830-7092; Investor Phone: (888) 289-5533
or
PondelWilkinson
Inc. Investor Relations
pwinvestor@pondel.com
Roger
Pondel: (310) 279-5965; Laurie Berman: (310) 279-5962
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