First Patient Dosed with LIXTE’s LB-100 in New Clinical Trial to Treat Colorectal Cancer, Collaborating with NKI, Supported by Major Pharma Company
LIXTE Biotechnology Holdings (Nasdaq: LIXT) has announced the dosing of the first patient in a new clinical trial for treating unresponsive metastatic colorectal cancer. The trial is a collaboration with the Netherlands Cancer Institute (NKI) and is supported by Roche. LIXTE is providing its lead compound, LB-100, while Roche is supplying atezolizumab (Tecentriq®), a PDL1 inhibitor. The trial aims to make immunotherapy an effective treatment option for approximately 85% of colorectal cancer patients who have not responded to traditional protocols. This marks the second recent clinical trial combining LB-100 with immunotherapy funded by a major pharmaceutical company, following an earlier trial with GSK for clear cell ovarian cancer treatment.
LIXTE Biotechnology Holdings (Nasdaq: LIXT) ha annunciato la somministrazione del primo paziente in un nuovo studio clinico per il trattamento del cancro colorettale metastatico non responsivo. Lo studio è una collaborazione con il Netherlands Cancer Institute (NKI) ed è supportato da Roche. LIXTE fornisce il suo composto principale, LB-100, mentre Roche fornisce atezolizumab (Tecentriq®), un inibitore di PDL1. L'obiettivo dello studio è rendere l'immunoterapia un'opzione di trattamento efficace per circa il 85% dei pazienti con cancro colorettale che non hanno risposto ai protocolli tradizionali. Questo segna il secondo recente studio clinico che combina LB-100 con immunoterapia finanziato da una grande compagnia farmaceutica, dopo un precedente studio con GSK per il trattamento del cancro ovarico a cellule chiare.
LIXTE Biotechnology Holdings (Nasdaq: LIXT) ha anunciado la dosificación del primer paciente en un nuevo ensayo clínico para tratar cáncer colorrectal metastásico no responsivo. El ensayo es una colaboración con el Netherlands Cancer Institute (NKI) y cuenta con el apoyo de Roche. LIXTE está proporcionando su compuesto líder, LB-100, mientras que Roche suministra atezolizumab (Tecentriq®), un inhibidor de PDL1. El ensayo tiene como objetivo hacer de la inmunoterapia una opción de tratamiento efectiva para aproximadamente el 85% de los pacientes con cáncer colorrectal que no han respondido a los protocolos tradicionales. Este es el segundo ensayo clínico reciente que combina LB-100 con inmunoterapia financiado por una importante compañía farmacéutica, después de un ensayo anterior con GSK para el tratamiento del cáncer de ovario de células claras.
LIXTE Biotechnology Holdings (Nasdaq: LIXT)는 반응하지 않는 전이성 대장암 치료를 위한 새로운 임상 시험에서 첫 환자에 대한 약물 투여를 발표했습니다. 이 시험은 네덜란드 암 연구소(NKI)와의 협력으로 진행되며 로슈의 지원을 받고 있습니다. LIXTE는 자사의 주력 화합물인 LB-100을 제공하고, 로슈는 PDL1 억제제인 아테졸리주맙(Tecentriq®)을 공급합니다. 이 시험의 목적은 전통적인 프로토콜에 반응하지 않은 약 85%의 대장암 환자에게 면역 요법을 효과적인 치료 옵션으로 만드는 것입니다. 이번이 주요 제약 회사가 자금을 지원하는 LB-100과 면역 요법을 결합한 두 번째 최근 임상 시험으로, GSK와 함께한 맑은 세포 난소암 치료를 위한 이전 시험에 이어 진행됩니다.
LIXTE Biotechnology Holdings (Nasdaq: LIXT) a annoncé la dose du premier patient dans un nouvel essai clinique pour traiter le cancer colorectal métastatique réfractaire. Cet essai est une collaboration avec le Netherlands Cancer Institute (NKI) et est soutenu par Roche. LIXTE fournit son principal composé, LB-100, tandis que Roche fournit atezolizumab (Tecentriq®), un inhibiteur de PDL1. L'objectif de l'essai est de faire de l'immunothérapie une option de traitement efficace pour environ 85% des patients atteints de cancer colorectal qui n'ont pas répondu aux protocoles traditionnels. Cela marque le deuxième essai clinique récent combinant LB-100 et immunothérapie financé par une grande entreprise pharmaceutique, après un essai antérieur avec GSK pour le traitement du cancer de l'ovaire à cellules claires.
LIXTE Biotechnology Holdings (Nasdaq: LIXT) hat die Dosierung des ersten Patienten in einer neuen klinischen Studie zur Behandlung von nicht ansprechendem metastasiertem Kolorektalkrebs bekannt gegeben. Die Studie erfolgt in Zusammenarbeit mit dem Netherlands Cancer Institute (NKI) und wird von Roche unterstützt. LIXTE stellt seinen Hauptbestandteil, LB-100, zur Verfügung, während Roche atezolizumab (Tecentriq®), einen PDL1-Inhibitor, bereitstellt. Ziel der Studie ist es, die Immuntherapie zu einer effektiven Behandlungsoption für etwa 85% der Kolorektalkrebspatienten zu machen, die nicht auf traditionelle Protokolle angesprochen haben. Dies markiert die zweite kürzliche klinische Studie, die LB-100 mit Immuntherapie kombiniert und von einem bedeutenden Pharmaunternehmen finanziert wird, nach einer früheren Studie mit GSK zur Behandlung von klarzelligem Ovarialkarzinom.
- Collaboration with Netherlands Cancer Institute and support from major pharma company Roche
- Potential to expand immunotherapy treatment to 85% of colorectal cancer patients
- Second recent clinical trial combining LB-100 with immunotherapy funded by a major pharmaceutical company
- None.
Insights
The initiation of this clinical trial marks a significant milestone in the quest to expand immunotherapy's efficacy in colorectal cancer treatment. Currently, only about 15% of colorectal cancer patients, those with high microsatellite instability (MSI-High), respond well to immunotherapy. This trial aims to address the unmet need for the remaining 85% of patients with MSI-Low tumors.
The combination of LIXTE's LB-100 with Roche's atezolizumab is a novel approach. LB-100, a protein phosphatase 2A (PP2A) inhibitor, may enhance the immune system's ability to recognize and attack cancer cells when combined with immunotherapy. This could potentially overcome the resistance mechanisms in MSI-Low tumors.
The involvement of the Netherlands Cancer Institute and support from Roche through the imCORE Network adds credibility and resources to this study. If successful, this trial could significantly expand the patient population benefiting from immunotherapy in colorectal cancer treatment.
This clinical trial initiation is a positive development for LIXTE Biotechnology. The collaboration with a prestigious institution like NKI and support from a pharmaceutical giant like Roche significantly enhances LIXTE's credibility and reduces its financial burden. This is the second major pharma-supported trial for LB-100 in combination with immunotherapy, following the GSK-supported ovarian cancer trial.
For a small biotech company, having two major pharmaceutical companies interested in your lead compound is a strong validation of its potential. This could lead to future partnerships or licensing deals if the trials show promising results. However, investors should note that clinical trials, especially in early stages, carry significant risks and uncertainties.
The potential market for this treatment is substantial, given that colorectal cancer is the third most common cancer globally. If successful, this therapy could address a large unmet medical need, potentially translating into significant revenue for LIXTE in the long term.
PASADENA, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) (“LIXTE” or the “Company”), today announced the dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer Institute (NKI) and supported by F. Hoffmann-La Roche Ltd. (“Roche”) for treatment of unresponsive (MSI Low) metastatic colorectal cancer.
As part of the clinical trial (NCT06012734, clinicaltrials.gov), LIXTE is providing its lead compound, LB-100, and Roche is providing atezolizumab (Tecentriq ®, a PDL1 inhibitor) through the imCORE Network, a global academic-industry partnership that aims to accelerate cancer immunotherapy research through institution-sponsored studies.
“Our objective with this trial is to bring immunotherapy as an effective treatment option to approximately 85 percent of all colorectal cancer patients, who thus far have not been responsive to traditional protocols,” said Neeltje Steeghs, M.D., Ph.D., medical oncologist at NKI.
Bas van der Baan, LIXTE’s Chief Executive Officer, said, “We are pleased to begin this important trial, which is being funded by Roche. This is the second recent clinical trial combining LB-100 with immunotherapy that is funded by a major pharmaceutical company, following the start of a clinical trial earlier this year with GSK for treatment of clear cell ovarian cancer.”
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 colorectal, ovarian 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
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