LIXTE Biotechnology Holdings announces collaboration on a New Colon Cancer Clinical Trial
LIXTE Biotechnology Holdings announced a collaboration with Roche and the Netherlands Cancer Institute (NKI) to conduct a new clinical trial targeting immune therapy unresponsive (MSI Low) metastatic colon cancer. The trial, listed as NCT06012734, will investigate the efficacy of LIXTE's lead compound, LB-100, in combination with Roche's PD-L1 inhibitor, atezolizumab (Tecentriq®). Approximately 85% of colon cancers are MSI Low and non-responsive to immunotherapy. The aim is to enhance immunotherapy efficacy for these patients. The collaboration highlights the scientific potential of LB-100, which has shown promise in pre-clinical data and previous trials. This study is the second recent collaboration with a major pharmaceutical company, following a GSK-supported trial for clear cell ovarian cancer.
- Collaboration with Roche and NKI on a new clinical trial increases credibility.
- Focus on MSI Low metastatic colon cancer, which constitutes 85% of cases unresponsive to current immunotherapy.
- Potential to make immunotherapy viable for a larger group of colon cancer patients.
- Ongoing interest and support from major pharmaceutical companies, including Roche and GSK.
- LB-100 has shown strong synergy with checkpoint immunotherapy in pre-clinical data.
- Second recent clinical trial combining LB-100 with immunotherapy.
- No financial data or funding details for the new trial were provided.
- The success of the trial is still uncertain as it is in the clinical stage.
- Potential risks if LB-100 fails to sensitize MSI Low tumors to immunotherapy.
Insights
Financial Analyst Perspective: The collaboration with Roche and the Netherlands Cancer Institute (NKI) to conduct a new clinical trial involving LIXTE’s compound LB-100 is a significant development for LIXTE Biotechnology Holdings. This partnership underscores the scientific potential of LB-100 and could attract investor interest due to the involvement of industry titans like Roche. Financially, the backing and resources from Roche reduce the financial burden on LIXTE and de-risk the trial process, which could be particularly reassuring to current and potential investors.
Moreover, if the clinical trial successfully demonstrates that LB-100 can sensitize MSI Low colon cancer tumors to immunotherapy, it could substantially expand the market for LB-100, presenting a lucrative opportunity. However, investors should also be aware of the inherent risks and the usual high costs and long timelines associated with clinical trials. The market has already seen numerous instances where promising compounds fail in later stages of trials, which can lead to significant financial setbacks.
Oncology Doctor Perspective: The announcement of a clinical trial aiming to improve immunotherapy responsiveness in MSI Low metastatic colon cancer is clinically significant. Currently, only about 15% of colon cancers respond to immunotherapy due to their MSI High status. If LB-100 can indeed turn 'cold' tumors 'hot' as suggested by preclinical data, it represents a potentially groundbreaking shift in the treatment paradigm for a large subset of colon cancer patients.
From an oncology standpoint, this trial could offer new hope for patients who have limited treatment options. The use of a PD-L1 inhibitor like atezolizumab (Tecentriq®) in combination with LB-100 also aligns with current trends in personalized medicine, emphasizing tailored therapeutic approaches based on tumor biology. It is essential to monitor the trial results carefully, as they could validate LB-100's efficacy and safety in a real-world clinical setting.
Market Research Analyst Perspective: The collaboration between LIXTE, Roche and the Netherlands Cancer Institute signals a strong endorsement of LB-100’s potential. Roche’s involvement, in particular, lends considerable credibility and resources, which can expedite the clinical trial process. This partnership may enhance LIXTE’s market position, as positive trial outcomes could lead to partnerships or acquisitions by larger pharmaceutical companies, eager to expand their oncology portfolios.
The market potential for an effective treatment in MSI Low colon cancer is substantial, given the large percentage of patients who currently do not benefit from immunotherapy. However, investors should also consider competitive dynamics. Many companies are actively pursuing advancements in immunotherapy, which could impact market share and revenue potential. The key will be how LB-100 stands out in terms of efficacy, safety and cost-effectiveness compared to other emerging treatments.
Clinical trial to test recent findings that show LIXTE’s lead clinical compound,
LB-100, increases recognition of colon cancer cells by the immune system
PASADENA, CA, June 14, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced a collaboration with Roche and the Netherlands Cancer Institute (NKI) to conduct a new clinical trial in immune therapy unresponsive (MSI Low) metastatic colon cancer.
As part of the new clinical trial, listed as NCT06012734 at clinicaltrials.gov, LIXTE will provide its lead compound, LB-100, and Roche will provide atezolizumab (Tecentriq®, a PD-L1 inhibitor) through the imCORE Network, an academic-industry collaboration that aims to accelerate cancer immunotherapy research through institution-sponsored studies.
“This is an exciting new clinical trial,” said Neeltje Steeghs, M.D., Ph.D., medical oncologist from NKI and Antoni van Leeuwenhoek Hospital, who is serving as principal investigator of the trial. “Only about
Bas van der Baan, LIXTE’s Chief Executive Officer, said, “The ongoing interest in and support of this clinical trial underscores the strength of the scientific rationale and potential of our lead compound, LB-100. This is the second recent clinical trial combining LB-100 with immunotherapy that is supported by a major pharmaceutical company, following the start of a clinical trial earlier this year that is being funded by GSK for the treatment of clear cell ovarian cancer.”
NKI is one of the world’s leading comprehensive cancer centers. René Bernards, Ph.D., a leader in the field of molecular carcinogenesis and Senior Staff Scientist at the Netherlands Cancer Institute, is a member of LIXTE’s Board of Directors.
A recent publication of new pre-clinical data in the journal EMBO Reports showed that LIXTE’s lead compound, LB-100, can turn immunologically “cold” tumors “hot,” thereby potentially enhancing the response to immunotherapy. This publication builds on a large body of scientific and emerging clinical evidence that LB-100 has strong synergy with checkpoint immunotherapy.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
About LIXTE Biotechnology Holdings, Inc.
LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on new targets for cancer drug development and developing and commercializing cancer therapies. LIXTE has demonstrated that its first-in-class lead clinical PP2A inhibitor, LB-100, is well-tolerated in cancer patients at doses associated with anti-cancer activity. Based on extensive published preclinical data (see www.lixte.com), LB-100 has the potential to significantly enhance chemotherapies and immunotherapies and improve outcomes for patients with cancer.
LIXTE’s lead compound, LB-100, is part of a pioneering effort in an entirely new field of cancer biology – activation lethality – that is advancing a new treatment paradigm. LIXTE's new approach is covered by a comprehensive patent portfolio. Proof-of-concept clinical trials are currently in progress for colon, small cell lung and sarcoma cancers. 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: (310) 279-5965; Laurie Berman: (310) 279-5962
FAQ
What is the stock symbol for LIXTE Biotechnology Holdings?
What is the new clinical trial announced by LIXTE Biotechnology Holdings?
When was the collaboration for the new clinical trial announced?
What is the significance of MSI Low in colon cancer?
What is the clinical trial identifier for the new study by LIXTE Biotechnology Holdings?
Which companies are involved in the new clinical trial with LIXTE Biotechnology Holdings?
What is LB-100?
