Lixte Biotechnology Holdings Inc. (LIXT)

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Lixte Biotechnology’s LB-100 Reported to Convert Immunologically Unresponsive (“Cold”) Tumors to Immunologically Responsive (“Hot”) Tumors

Source: GlobeNewswire Inc.

Lixte Biotechnology Holdings, Inc. (Nasdaq: LIXT), a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, announced today that in preclinical studies its lead clinical compound, LB-100, a protein phosphatase (PP2A) inhibitor, was found to increase the responsiveness of diverse cancers to immunotherapy. In Nature Communications (15 Dec 2021), lead author Yu-Ting Yen and colleagues at the China Medical University and Hospital, Taichung, Taiwan reported that treatment with LB-100 is associated with new antigen production, tumor infiltration of cytotoxic T cells, and enhanced responsiveness to immune checkpoint blockade in mouse models of colorectal, triple-negative breast, and pancreatic cancer. The authors state that “these data indicate that PP2A inhibition can be used to change the intrinsic and extrinsic factors of tumors to improve the success rate of anti-cancer immunotherapy.”
Lixte’s founder and CEO, John S. Kovach M.D, commented that “recent advances in therapy with immune checkpoint inhibitors have been a true breakthrough in the development of more effective and less toxic treatment for many cancers. Unfortunately, most cancer patients do not respond to immunotherapy. There are widespread efforts to find pharmacologic and/or immunologic ways to turn unresponsive (‘cold’) tumors into responsive (‘hot’) tumors. Cancers with a molecular abnormality termed microsatellite-instability (MSI) stemming from a defect in a DNA repair enzyme are generally ‘hot’ tumors, that is, tumors responsive to immunotherapy. Yen and colleagues now report that pharmacologic inhibition of PP2A by LB-100 modifies two distinct molecular pathways resulting in conversion of microsatellite stable (MSS) tumors into MSI tumors sensitive immune checkpoint blockade therapy.”

Dr. Kovach concluded: “The results of Yen et al. raise the possibility that the addition of LB-100 to immunotherapy may be a simple way to convert ‘cold’ into ‘hot’ tumors, thereby increasing the percentage of patients responsive to immunotherapy. Lixte recently initiated a clinical trial in patients with previously untreated extensive stage small cell lung cancer in which LB-100 is first added to chemotherapy and an immune checkpoint blocker and then administered with the immune blocker alone in the maintenance phase of treatment (NCT04560972). Lixte is interested in collaborative studies designed to determine whether LB-100 broadly enhances the benefit of immunotherapy. Immune checkpoint blockers are now approved for treatment of at least 20 cancer types.”

About Lixte Biotechnology Holdings, Inc.

Lixte Biotechnology Holdings, Inc. (Nasdaq: LIXT) is a clinical-stage pharmaceutical company dedicated to discovering drugs for more effective treatments for many forms of cancer and other serious common diseases. A major driver of cancer is defects in the switches that turn the biochemical pathways in cells on and off. Most cancer research over the past 30 years has focused on the “on” switches because the “off” switches, especially the master “off” switch protein phosphatase (PP2A), were believed to cause intolerable toxicity in patients. Lixte has achieved a breakthrough with its novel, first-in-class lead clinical compound and PP2A inhibitor, LB-100, by demonstrating that this compound is readily tolerated in cancer patients at doses associated with anti-cancer activity. This innovative approach encourages cancer cells damaged by chemo or other cancer therapies to continue to replicate before repairing the damage, leading to more efficient killing of those cells. LB-100 is being tested in three clinical cancer treatment studies with others in planning. www.lixte.com

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 position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future product demand, supply, manufacturing, costs, marketing and pricing factors 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, research results, competition from other similar businesses, and market and general economic factors. This discussion should be read in conjunction with the Company's filings with the United States Securities and Exchange Commission at sec.gov/edgar.shtml.

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