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LIXTE Biotechnology Holdings to Collaborate with Roche and Netherlands Cancer Institute in New Colon Cancer Clinical Trial

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Rhea-AI Summary

LIXTE Biotechnology Holdings has announced a collaboration with Roche and the Netherlands Cancer Institute (NKI) for a new clinical trial targeting MSI Low metastatic colon cancer. The trial, registered as NCT06012734, will test LIXTE's lead compound LB-100 in combination with Roche's PD-L1 inhibitor, atezolizumab. NKI's Dr. Neeltje Steeghs will lead the trial, aiming to improve immunotherapy efficacy for the 85% of colon cancers unresponsive to current treatments. This collaboration follows another recent trial funded by GSK for clear cell ovarian cancer, highlighting the pharmaceutical industry's support for LB-100's potential. This trial could significantly impact colon cancer treatment by making immunotherapy viable for a larger patient group.

Positive
  • Collaboration with Roche and NKI increases credibility and resources.
  • Trial targets 85% of colon cancer cases unresponsive to current therapies.
  • LB-100 has shown potential to enhance immunotherapy efficacy.
  • Roche provides financial support, alleviating cost burdens for LIXTE.
  • Second recent trial involving LB-100 fully funded by a major pharmaceutical company.
  • NKI, a world-leading cancer center, adds further legitimacy to the trial.
Negative
  • The success of the trial is uncertain and may not yield positive results.
  • Dependence on external funding could pose financial risks if partnerships dissolve.
  • High competition in the pharmaceutical industry for effective cancer treatments.
  • Previous success in pre-clinical data does not guarantee clinical trial success.

Insights

The collaboration between LIXTE Biotechnology Holdings, Roche and the Netherlands Cancer Institute to test LB-100 in metastatic colon cancer represents a potentially significant advance in oncology. The focus on MSI Low cancers, which are generally unresponsive to immunotherapy, could redefine treatment paradigms if successful. Current treatments for MSI Low colon cancer have limited efficacy, making this trial particularly promising.

LB-100's ability to increase immune system recognition of cancer cells is intriguing because it addresses a critical challenge in cancer therapy: turning 'cold' tumors 'hot'. This could enhance the effectiveness of existing immunotherapies like atezolizumab. Given that 85% of colon cancers are MSI Low and unresponsive to current immunotherapies, a positive outcome from this trial could vastly expand the population of patients who benefit from immunotherapy, improving survival rates.

Additionally, the involvement of Roche, a leader in cancer immunotherapy, lends credibility and resources to the trial. This collaboration also underscores the urgent need for innovation in treating resistant cancer types.

From a financial perspective, the collaboration is quite promising for LIXTE Biotechnology Holdings. The financial backing from Roche significantly reduces the financial burden on LIXTE, enabling the company to allocate resources more efficiently. Roche's involvement also suggests confidence in LB-100's potential, which could attract further investments and partnerships. The fact that this is the second major collaboration within a year highlights growing interest and validation from big pharmaceutical companies.

Investors should note that successful clinical trials could lead to substantial increases in the company's stock value due to the expansion of their market potential. However, it’s important to remain cautious as clinical trials come with inherent risks. The trial's outcome will be pivotal in determining the long-term financial viability and market penetration of LB-100.

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 (a PD-L1 inhibitor) and financial support.

“This is an exciting new clinical trial,” said Neeltje Steeghs, M.D., Ph.D., medical oncologist from the Netherlands Cancer Institute, who is serving as principal investigator of the trial. “Only about 15% of colon cancers are responsive to immunotherapy, the so-called MSI High cancers. However, approximately 85% of colon cancers are MSI Low where immunotherapy has no activity at all. If we are able to sensitize these tumors to immunotherapy with LB-100, we could bring immunotherapy as an effective treatment option to a large group of colon cancer patients.”

Bas van der Baan, LIXTE’s Chief Executive Officer, said, “The continuing interest of the pharmaceutical industry to collaborate with us and fund our clinical trials 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 fully funded 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.

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 new clinical trial involving LIXTE's LB-100?

The new clinical trial, registered as NCT06012734, will test LIXTE's LB-100 in combination with Roche's PD-L1 inhibitor atezolizumab for MSI Low metastatic colon cancer.

When was the collaboration between LIXTE, Roche, and NKI announced?

The collaboration was announced on June 14, 2024.

What percentage of colon cancers are targeted in the new LIXTE trial?

The trial targets approximately 85% of colon cancers that are MSI Low and currently unresponsive to immunotherapy.

Who is the principal investigator for the LIXTE, Roche, and NKI clinical trial?

Dr. Neeltje Steeghs from the Netherlands Cancer Institute is the principal investigator.

What potential impact could the LIXTE and Roche collaboration have on colon cancer treatment?

The collaboration aims to make immunotherapy effective for a larger group of colon cancer patients, potentially transforming treatment options for those with MSI Low metastatic colon cancer.

Lixte Biotechnology Holdings, Inc.

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