Full Press Release Details
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
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
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.
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.
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
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."
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
LIXTE Biotechnology Holdings, Inc.
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.
Statement Disclaimer
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
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compliance with Nasdaq's continued listing requirements, are all forward-looking statements. These statements are generally accompanied
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"continue," "forecast," "predict," "plan," "may," "will," "could,"
"would," "should," "expect" or the negative of such terms or other comparable terminology.
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
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.
more information about LIXTE, Contact: info@lixte.com
Phone: (631) 830-7092; Investor Phone: (888) 289-5533
Inc. Investor Relations
Pondel: (310) 279-5965; Laurie Berman: (310) 279-5962