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LIXTE Provides Update on Progress with LB-100 as a PP2A Inhibitor to Enhance Chemotherapy and Immunotherapy Cancer Treatments

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LIXTE Biotechnology Holdings, Inc. provides an update on three ongoing clinical trials for treating ovarian, lung, and sarcoma cancers. The company is developing a new cancer therapy using LB-100 to enhance chemotherapy and immunotherapy. Significant developments include dosing the first patient in a Phase 1b/2 trial with GSK's dostarlimab-gxly for ovarian clear cell carcinoma, an exclusive patent license agreement with NIH, and new pre-clinical data presented by Dr. René Bernards on LB-100's unique mechanism of action.
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The initiation of clinical trials for LB-100 in treating various cancers represents a significant step in oncology, especially considering the involvement of renowned institutions like MD Anderson and City of Hope. The combination of LB-100 with immunotherapy and chemotherapy could potentially address the limitations of current treatments, offering a more robust approach to combat cancer's complexity. The focus on hard-to-treat cancers such as ovarian clear cell carcinoma, small cell lung cancer and advanced soft tissue sarcoma highlights an effort to target areas with high unmet medical needs. If LB-100 proves to be effective, it may lead to improved patient outcomes and could become a valuable addition to the oncology treatment arsenal.

The partnership between LIXTE and pharmaceutical giant GSK, along with the support from NIH, indicates a strong backing for LB-100's development. The licensing of NIH's intellectual property and the cooperative research agreement could accelerate the drug's development process. Moreover, the pre-clinical data presented by Dr. Bernards suggests that LB-100 may have a unique mechanism of action, potentially leading to a paradigm shift in how we understand and treat cancer. Investors should monitor the progress of these trials closely, as positive results could significantly impact LIXTE's valuation and attractiveness to potential partners or acquirers.

The filing of the Annual Report on Form 10-K provides transparency into LIXTE's financial health and operational performance. Investors should scrutinize this document for insights into the company's burn rate, capital structure and R&D expenses, particularly in light of the ongoing clinical trials. The outcomes of these trials could have substantial implications for the company's stock performance. A successful trial outcome may lead to an increase in stock value, while any setbacks could pose risks to investors. The strategic patent license agreement with NIH may also offer competitive advantages and could be a catalyst for future growth.

-- Three Clinical Trials Currently Underway for Treating Ovarian, Lung and Sarcoma Cancers --

PASADENA, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy, today provided an update on the Company’s progress with its proprietary compound, LB-100.

“Clinical trials are underway at leading cancer centers in the United States and Spain using LB-100 in combination with chemotherapy and immunotherapy that we are hopeful will provide new and effective treatment options for patients with lung, ovarian and sarcoma cancers,” said Bas van der Baan, LIXTE’s President and Chief Executive Officer.

Clinical trials are taking place at the University of Texas MD Anderson Cancer (ovarian clear cell carcinoma); City of Hope Cancer Center and the Sarah Cannon Research Institute (small cell lung cancer); and the Spanish Sarcoma Group (advanced soft tissue sarcoma).

Click here for a brief video overview by LIXTE’s Chief Executive Officer.

LIXTE recently announced the following significant developments:

  • The dosing of the first patient in a Phase 1b/2 clinical trial to assess whether adding LB-100 to GSK’s dostarlimab-gxly will enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (OCCC). The clinical trial was initiated by, and is being conducted at, the University of Texas MD Anderson Cancer Center. LIXTE is providing LB-100, and GSK is providing dostarlimab-gxly and financial support.
  • The signing of an exclusive patent license agreement with the National Institute of Neurological Disorders and Stroke and the National Cancer Institute, each an Institute of the National Institutes of Health (NIH). LIXTE has licensed NIH’s intellectual property rights under a Cooperative Research and Development Agreement that, focused on LB-100 promoting anti-cancer activity alone and in combination with immune checkpoint inhibitors.
  • On February 28, 2024, René Bernards, PhD, a leader in the field of molecular carcinogenesis and Senior Staff Scientist at the Netherlands Cancer Institute, presented new pre-clinical data at the Joint Conference of European and American Associations for Cancer Research in Dublin, Ireland on how stress imposed onto colon cancer cells by LB-100 drives cancer cells to evolve to less cancerous behavior, underscoring a unique mechanism of action of LB-100. Dr. Bernards is a member of the Board of Directors of LIXTE.

Filing of Annual Report on Form 10-K for the fiscal year ended December 31, 2023

Additional information with respect to LIXTE’s business, clinical trials and financial condition is contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which has been filed with the U.S. Securities and Exchange Commission at www.sec.gov.

About LIXTE Biotechnology Holdings, Inc. 

LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company developing a new class of cancer therapy, PP2A inhibitors. The Company’s novel approach enhances the efficacy of both chemotherapy and immunotherapy, potentially providing new treatment options for patients. At the core of the Company’s therapy is LB-100, LIXTE’s proprietary molecule that acts as an inhibitor of the PP2A phosphatase with a favorable toxicity profile. LB-100 promotes the production of neoantigens and cytokines, boosts T-cell proliferation, and disrupts the DNA repair mechanisms of cancer cells, potentially improving treatment outcomes. The Company is conducting multiple clinical trials for solid tumors with unmet medical needs. LIXTE’s unique approach has no known competitors and is covered by a comprehensive patent portfolio. 

Additional information about LIXTE can be found at www.lixte.com.

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 or Laurie Berman: (310) 279-5980

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FAQ

What type of cancers are the three ongoing clinical trials focused on by LIXTE?

The three ongoing clinical trials are focused on treating ovarian, lung, and sarcoma cancers.

What is the proprietary compound being used by LIXTE in these clinical trials?

LIXTE is using its proprietary compound, LB-100, to enhance chemotherapy and immunotherapy.

What significant development was announced regarding a Phase 1b/2 clinical trial for ovarian clear cell carcinoma?

The dosing of the first patient in a Phase 1b/2 clinical trial to assess the effectiveness of adding LB-100 to GSK's dostarlimab-gxly in treating ovarian clear cell carcinoma was announced.

Who presented new pre-clinical data on LB-100 at the Joint Conference of European and American Associations for Cancer Research?

Dr. René Bernards presented new pre-clinical data on LB-100 at the Joint Conference of European and American Associations for Cancer Research.

Where can additional information about LIXTE's business, clinical trials, and financial condition be found?

Additional information can be found in LIXTE's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission at www.sec.gov.

Lixte Biotechnology Holdings, Inc.

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