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Professor René Bernards to Present New Pre-Clinical Data on LIXTE’s LB-100 at Joint Conference of European and American Associations for Cancer Research

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LIXTE Biotechnology Holdings, Inc. presents new pre-clinical data on their lead compound LB-100 at a cancer research conference in Dublin. The data shows how LB-100 drives cancer cells to evolve into less aggressive behavior, positioning it as a promising cancer therapy. LIXTE also enters into a Patent License Agreement with NIH and initiates a clinical trial to assess LB-100's effectiveness in combination with immunotherapy for ovarian clear cell carcinoma.
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The recent pre-clinical findings related to LIXTE’s PP2A inhibitor, LB-100, present a novel approach to cancer treatment. Unlike traditional therapies that inhibit oncogenic signaling, LB-100 appears to overload these signals, potentially leading to a reversion of cancer cells to less aggressive states. This mechanism, which may induce cancer cells to downregulate malignancy markers, could signify a shift in oncological paradigms. However, it's imperative to view these results with cautious optimism until further clinical trials validate the efficacy and safety of LB-100 in patients.

Moreover, the synergy of LB-100 with checkpoint immunotherapy could represent a significant advancement in cancer therapy. The combination may enhance the immune system's ability to recognize and attack cancer cells, especially given the current interest in immunotherapy as a treatment modality. The ongoing Phase 1b/2 clinical trial combining LB-100 with dostarlimab-gxly in ovarian clear cell carcinoma will be critical in determining the clinical relevance of these pre-clinical findings.

The exclusive Patent License Agreement with the National Institute of Neurological Disorders and Stroke and the National Cancer Institute underscores the potential that LIXTE's technology holds. Intellectual property rights are crucial in the biotechnology industry, offering a competitive edge and a pathway to commercialization. The initiation of a clinical trial at a prestigious institution like MD Anderson Cancer Center further validates the scientific community's interest in LB-100.

Investors should monitor the progress of the clinical trials closely, as positive outcomes could lead to significant value creation, while any setbacks could pose risks. The impact on LIXTE's stock will depend on trial results, regulatory approvals and potential market size for LB-100 if it's proven to be effective and safe.

From a market perspective, the development of new cancer therapies like LB-100 could disrupt existing treatment protocols and create new market segments. The current focus on immunotherapies and their combinations has shown promise in treating various cancers, which suggests a growing market for innovative treatments like LB-100. The strategic patent licensing and the alignment with current oncological research trends could position LIXTE favorably in the market.

Understanding the competitive landscape and how LB-100 fits within it is essential. If LB-100 proves to be effective, it could capture a significant share of the cancer treatment market, particularly in indications where current treatments are limited or ineffective. However, the path to market is long and filled with regulatory hurdles and the company's financial health and ability to continue funding research and trials will be crucial for its long-term success.

Conference In Dublin, Ireland on February 27 - 29, 2024
Focuses on How to Bring Basic Science Discoveries to the Clinic

PASADENA, CA, Feb. 27, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) (“LIXTE” or the “Company”), a clinical stage biotechnology company developing a novel class of cancer therapy called PP2A inhibitors, today announced that René Bernards, PhD, professor of molecular carcinogenesis at Utrecht University in Amsterdam and head of molecular carcinogenesis at the Netherlands Cancer Institute, will present new pre-clinical data on LIXTE’s lead compound, LB-100, at the Joint Conference of European and American Associations for Cancer Research this week in Dublin, Ireland. Dr. Bernards is also a member of LIXTE’s Board of Directors.

In his presentation, “Unexpected, but Highly Synergistic Combinations for Cancer Therapy,” Dr. Bernards will present data on how stress imposed onto colon cancer cells by LB-100 drives cancer cells to evolve to less cancerous behavior.

“The findings underscore the unique and what we believe to be exciting features and mechanism of action of LIXTE’s PP2A inhibitor, LB-100,” said Dr. James Miser, LIXTE’s Chief Medical Officer. “While conventional cancer drugs aim to inhibit oncogenic signaling, which tends to drive cancer cells into more aggressive behavior, LB-100 does exactly the opposite, overloading oncogenic signaling, and thereby forcing cells to downregulate the signals that are characteristic for cancer cells. As a consequence, cancer cells are forced to evolve to a less aggressive behavior.”

“This new data greatly helps to position LB-100 clinically to the benefit of patients and is in addition to the well-established effects of LB-100 on enhancing the efficacy of checkpoint immunotherapy,” added Bas van der Baan, LIXTE’s President and CEO.

LIXTE yesterday announced it has entered into an exclusive Patent License Agreement with the National Institute of Neurological Disorders and Stroke and the National Cancer Institute, both units of the National Institute of Health. The Company also recently announced dosing of the first patient in a Phase 1b/2 clinical trial at MD Anderson Cancer Center to assess whether adding LIXTE’s LB-100 to GSK’s programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (OCCC).

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 demonstrated 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. 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


FAQ

What is the lead compound being presented by LIXTE at the cancer research conference in Dublin?

LIXTE is presenting new pre-clinical data on their lead compound LB-100 at the conference.

Who will present the new data on LB-100 at the conference?

Dr. René Bernards, a professor at Utrecht University and a member of LIXTE's Board of Directors, will present the new data.

What is the focus of Dr. Bernards' presentation at the conference?

Dr. Bernards will focus on how stress imposed by LB-100 drives cancer cells to evolve into less aggressive behavior.

What recent agreement has LIXTE entered into with the National Institute of Health?

LIXTE has entered into an exclusive Patent License Agreement with the National Institute of Neurological Disorders and Stroke and the National Cancer Institute.

What clinical trial has LIXTE initiated recently?

LIXTE has initiated a Phase 1b/2 clinical trial at MD Anderson Cancer Center to assess LB-100's effectiveness in combination with immunotherapy for ovarian clear cell carcinoma.

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