Lixte Biotechnology Holdings, Inc. (NASDAQ:LIXT) has announced an amendment to its Development Collaboration Agreement with the Netherlands Cancer Institute (NKI) and Oncode Institute, Utrecht, initially established on October 8, 2021. The collaboration focuses on identifying potential drugs for combination therapies with LB-100 and its analogues to treat various cancers, while also elucidating the underlying molecular mechanisms of these combinations.
Details of Amendment 3
Amendment 3 introduces a temporary suspension of ongoing study activities and associated payments until the commencement of a Phase 1b clinical trial. This trial will evaluate the combination of LB-100 with a WEE1 inhibitor in patients with metastatic colorectal cancer. The collaboration is slated to resume once the first patient is dosed in this trial, with the agreement's termination date extended to one year from the date of first dosing.
Budget and Data Analysis
The amendment also outlines a reduced annual budget of €100,000, invoiced quarterly, for the year following the effective date, a decrease from the initial budget of €250,000. Furthermore, the amendment enables the parties to analyze translational data derived from patient samples in clinical trials conducted at NKI. This is intended to provide deeper insights into the drug's mechanism of action and potential biomarkers for response.
LB-100 Clinical Development
LB-100, Lixte's lead product candidate, is currently undergoing Phase 1b clinical trials in combination with Atezolizumab for patients with microsatellite stable metastatic colon cancer. The drug is a protein phosphatase 2A (PP2A) activator, a novel mechanism of action that differentiates it from many traditional cancer therapies.
Financial Position and Nasdaq Compliance
Lixte Biotechnology also reported that its Common Stock (LIXT) and Warrant to Purchase Common Stock (LIXTW) are registered on The Nasdaq Stock Market LLC. The company recently received an extension from Nasdaq to meet the minimum stockholders’ equity requirement, now having until February 18, 2025, to raise its equity to at least $2,500,000. Lixte plans to regain compliance through registered equity offerings, aiming to raise up to $4 million.
Strategic Implications
This amendment reflects Lixte Biotechnology’s ongoing commitment to advancing its collaborative research efforts in oncology. By focusing on combination therapies and understanding the molecular mechanisms of LB-100, Lixte aims to improve treatment outcomes for cancer patients. The collaboration with NKI and Oncode Institute provides access to valuable expertise and resources, enhancing the potential for successful drug development.
