First patient receives LB-100 from LIXTE in new clinical trial for the treatment of colon cancer in collaboration with NKI and with the support of a major pharmaceutical company

PASADENA, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) — LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) (“LIXTE” or the “Company”) today announced the dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer Institute (NKI) and supported by F. Hoffmann-La Roche Ltd. (“Roche”) for the treatment of unresponsive (MSI low), metastatic colorectal cancer.

As part of the clinical trial (NCT06012734, clinicaltrials.gov), LIXTE is providing its lead compound LB-100 and Roche is providing atezolizumab (Tecentriq ^®a PDL1 inhibitor) through the imCORE network, a global academic-industry partnership aimed at accelerating cancer immunotherapy research through institutionally sponsored trials.

“With this study, we want to offer an effective treatment option with immunotherapy to around 85 percent of all patients with colon cancer for whom conventional treatment protocols have not yet been effective,” said Dr. Neeltje Steeghs, medical oncologist at the NKI.

Bas van der Baan, Chief Executive Officer of LIXTE, said: “We are delighted to start this important study funded by Roche. This is the second clinical trial combining LB-100 with immunotherapy funded by a major pharmaceutical company. A clinical trial with GSK for the treatment of clear cell ovarian cancer was initiated earlier this year.”

About LIXTE Biotechnology Holdings, Inc.

LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on novel targets for cancer drug development and the development and commercialization of cancer therapies. LIXTE has demonstrated that its lead clinical PP2A inhibitor, LB-100, the first in its class, is well tolerated in cancer patients at doses associated with anticancer activity. Based on extensive published preclinical data (see www.lixte.com) LB-100 has the potential to significantly improve chemotherapy and immunotherapy and improve outcomes for cancer patients.

LIXTE's lead compound LB-100 is part of a pioneering effort in an entirely new area of ​​cancer biology – activation lethality – that is driving a new treatment paradigm. LIXTE's new approach is protected by a comprehensive patent portfolio, and proof-of-concept clinical trials are currently underway for colorectal, ovarian and sarcoma cancer. For more information about LIXTE, please visit www.lixte.com.

Disclaimer for forward-looking statements

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 condition, business strategy and other plans and objectives for future operations, and assumptions and projections regarding future activities, including the ongoing development of proprietary compounds, the planning, financing, coordination and potential results of clinical trials, patent and legal costs to protect and maintain the Company's intellectual property worldwide and the Company's ability to meet and maintain Nasdaq's requirements for a continuous listing are all forward-looking statements. These statements are generally accompanied by words such as “intend,” “anticipate,” “believe,” “estimate,” “potential,” “continue,” “project,” “forecast,” “plan,” “may,” “will,” “could,” “would,” “should,” “expect” or the negative of these terms or other comparable terminology.

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The Company believes that the assumptions and expectations reflected in such forward-looking statements are reasonable based on information available to it at the time of this release. However, the Company can give no assurance that these assumptions and expectations will prove to be correct or that the Company will take any action it currently contemplates. However, by their nature, these forward-looking statements involve known and unknown risks and uncertainties. Actual results or experience may differ materially from those anticipated or projected in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies, availability of cash, research results, competition from other similar companies, and market and general economic factors.

Readers are urged to read the risk factors set out in the Company’s filings with the Securities and Exchange Commission (SEC) at https://www.sec.govThe 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, please visit: [email protected]
General Telephone: (631) 830-7092; Investor Telephone: (888) 289-5533

or

PondelWilkinson Inc. Investor Relations [email protected]
Roger Pondel: (310) 279-5965; Laurie Berman: (310) 279-5962