UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Item 1.01 | Entry Into a Material Agreement. |
Effective June 10, 2024, Lixte Biotechnology Holdings, Inc. (the “Company”) entered into a Clinical Trial Agreement (the “Agreement”) with the Netherlands Cancer Institute (“NKI”) to conduct a Phase 1b/2 clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined with atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F. Hoffman-La Roche Ltd. (“Roche”), for patients with metastatic colon cancer. Under the Agreement, the Company will provide its lead compound, LB-100, and under a separate agreement between NKI and Roche, Roche will provide atezolizumab and financial support for the clinical trial. The Company has no obligation to, and will not provide any reimbursement of clinical trial costs. Pursuant to the Agreement and the protocol set forth in the Agreement, the clinical trial will be conducted by NKI at NKI’s site in Amsterdam by principal investigator Neeltje Steeghs, MD, PhD, and NKI will be responsible for the recruitment of patients. The Agreement provides for the protection of the respective intellectual property rights of each of the Company, NKI and Roche.
This Phase 1b clinical trial will evaluate the side effects and optimal dose of LB-100 combined with atezolizumab for the treatment of patients with metastatic microsatellite stable colorectal cancer. Immunotherapy using monoclonal antibodies like atezolizumab can enhance the body’s immune response against cancer and hinder tumor growth and spread. LB-100 has been found to improve the effectiveness of anticancer drugs in killing cancer cells by inhibiting a protein called PP2A on cell surfaces. Blocking PP2A increases stress signals in tumor cells expressing the PP2A protein. Accordingly, combining atezolizumab with LB-100 may enhance treatment efficacy for metastatic colorectal cancer, as cancer cells with heightened stress signals are more vulnerable to immunotherapy.
This study comprises a dose escalation phase and a dose expansion phase. The objective of the dose escalation phase is to determine the recommended Phase 2 dose (RP2D) of LB-100 when combined with the standard dosage of atezolizumab. The dose expansion phase will further investigate the clinical activity, safety, tolerability, and pharmacokinetics/dynamics of the LB-100 and atezolizumab combination. The clinical trial is scheduled to open by June 30, 2024. Patient accrual is expected to take up to 24 months, with a maximum of 37 patients with advanced colorectal cancer to be enrolled in this study.
Additional information on the clinical trial is available on the clinicaltrials.gov website at https://clinicaltrials.gov/study/NCT06012734.
The foregoing description of the terms of the Agreement does not purport to be complete and is subject to and qualified in its entirety by reference to the Agreement, a copy of which is filed with this Form 8-K and incorporated by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) The Exhibits listed on the accompanying Index to Exhibits are incorporated herein by reference.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: June 14, 2024 | LIXTE BIOTECHNOLOGY HOLDINGS, INC. (Registrant) | |
| By: | /s/ BASTIAAN VAN DER BAAN | |
| Bastiaan van der Baan | ||
| Chief Executive Officer | ||
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INDEX TO EXHIBITS
| Exhibit No. | Description | |
| 10.1 | Clinical Trial Agreement dated as of June 10, 2024 between the Company and the Netherlands Cancer Institute. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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