LIXTE Biotechnology Provides Update On Recent Activities and Developments
LIXTE Biotechnology Holdings, Inc. (LIXT) has announced several significant developments:
1. A new collaboration with The Netherlands Cancer Institute, supported by Roche, for a clinical trial in metastatic colorectal cancer using LB-100 and atezolizumab.
2. Appointment of Dr. Jan Schellens as Chief Medical Officer, bringing extensive oncology and drug development experience.
3. Publication of preclinical data in EMBO Reports showing LB-100's potential to enhance immunotherapy benefits.
4. Ongoing clinical trials, including a GSK-funded study of LB-100 with dostarlimab-gxly in ovarian clear cell cancer and a soft tissue sarcomas trial with expected data in early 2025.
5. Upcoming presentations at two investor conferences in August and September 2024.
LIXTE Biotechnology Holdings, Inc. (LIXT) ha annunciato diversi sviluppi significativi:
1. Una nuova collaborazione con il Netherlands Cancer Institute, supportata da Roche, per un trial clinico sul cancro colorettale metastatico utilizzando LB-100 e atezolizumab.
2. Nomina del Dr. Jan Schellens come Chief Medical Officer, che porta una vasta esperienza in oncologia e sviluppo di farmaci.
3. Pubblicazione di dati preclinici su EMBO Reports che dimostrano il potenziale di LB-100 di migliorare i benefici dell'immunoterapia.
4. Studio clinico in corso, incluso uno sponsorizzato da GSK che testa LB-100 con dostarlimab-gxly nel carcinoma ovarico a cellule chiare e un trial sui sarcomi dei tessuti molli con dati previsti per inizio 2025.
5. Prossime presentazioni a due conferenze per investitori ad agosto e settembre 2024.
LIXTE Biotechnology Holdings, Inc. (LIXT) ha anunciado varios desarrollos significativos:
1. Una nueva colaboración con el Netherlands Cancer Institute, respaldada por Roche, para un ensayo clínico en cáncer colorrectal metastásico utilizando LB-100 y atezolizumab.
2. Nombramiento del Dr. Jan Schellens como Chief Medical Officer, aporta una gran experiencia en oncología y desarrollo de medicamentos.
3. Publicación de datos preclínicos en EMBO Reports que muestran el potencial de LB-100 para mejorar los beneficios de la inmunoterapia.
4. Ensayos clínicos en curso, incluyendo un estudio financiado por GSK de LB-100 con dostarlimab-gxly en cáncer de ovario de células claras y un ensayo sobre sarcomas de tejidos blandos con datos esperados a principios de 2025.
5. Próximas presentaciones en dos conferencias para inversionistas en agosto y septiembre de 2024.
LIXTE Biotechnology Holdings, Inc. (LIXT)는 여러 중요한 개발 사항을 발표했습니다:
1. 네덜란드 암 연구소와의 새로운 협력으로, 로슈의 지원을 받아 LB-100과 아테졸리주맙을 사용한 전이성 대장암 임상시험을 진행합니다.
2. Dr. Jan Schellens를 최고 의료 책임자로 임명하였으며, 그는 종양학 및 약물 개발 분야에서 폭넓은 경험을 보유하고 있습니다.
3. LB-100이 면역 요법의 이점을 향상시킬 가능성을 보여주는 전임상 데이터가 EMBO Reports에 발표되었습니다.
4. 진행 중인 임상시험에는 GSK가 자금을 지원하는 LB-100과 도스타림맙-gxly를 사용한 난소 투명 세포암 연구와 2025년 초에 데이터가 예상되는 연부 조직 육종 시험이 포함됩니다.
5. 2024년 8월과 9월에 열리는 두 개의 투자자 회의에서 발표가 예정되어 있습니다.
LIXTE Biotechnology Holdings, Inc. (LIXT) a annoncé plusieurs développements significatifs :
1. Une nouvelle collaboration avec le Netherlands Cancer Institute, soutenue par Roche, pour un essai clinique sur le cancer colorectal métastatique utilisant LB-100 et atezolizumab.
2. Nommer Dr. Jan Schellens en tant que Chief Medical Officer, apportant une vaste expérience en oncologie et en développement de médicaments.
3. Publication de données précliniques dans EMBO Reports montrant le potentiel de LB-100 à améliorer les bénéfices de l'immunothérapie.
4. Essais cliniques en cours, y compris une étude financée par GSK sur LB-100 avec dostarlimab-gxly dans le cancer ovarien à cellules claires et un essai sur les sarcomes des tissus mous dont les données sont attendues début 2025.
5. Prochaines présentations lors de deux conférences pour investisseurs en août et septembre 2024.
LIXTE Biotechnology Holdings, Inc. (LIXT) hat mehrere bedeutende Entwicklungen bekannt gegeben:
1. Eine neue Zusammenarbeit mit dem Niederländischen Krebsinstitut, unterstützt von Roche, für eine klinische Studie zu metastasierendem kolorektalen Krebs unter Verwendung von LB-100 und Atezolizumab.
2. Ernennung von Dr. Jan Schellens zum Chief Medical Officer, der umfangreiche Erfahrung in der Onkologie und der Arzneimittelentwicklung mitbringt.
3. Veröffentlichung von präklinischen Daten in EMBO Reports, die das Potenzial von LB-100 zur Verbesserung der Vorteile der Immuntherapie zeigen.
4. Laufende klinische Studien, einschließlich einer von GSK finanzierten Studie zu LB-100 mit Dostarlimab-gxly bei klarzelligem Ovarialkarzinom und einer Studie zu Weichgewebssarkomen mit erwarteten Daten Anfang 2025.
5. Kommende Präsentationen auf zwei Investorenkonferenzen im August und September 2024.
- New collaboration with The Netherlands Cancer Institute and Roche for a clinical trial in metastatic colorectal cancer
- Appointment of experienced oncologist Dr. Jan Schellens as Chief Medical Officer
- Preclinical data published in EMBO Reports shows LB-100's potential to enhance immunotherapy benefits
- Ongoing GSK-funded clinical trial of LB-100 plus dostarlimab-gxly in ovarian clear cell cancer
- Encouraging results in the first phase of soft tissue sarcomas clinical trial, with data expected in early 2025
- Termination of small cell lung cancer trial at City of Hope due to patient accrual
Insights
The collaboration between LIXTE, NKI and Roche for a new colorectal cancer trial is a significant development. The study (NCT06012734) will test LB-100's potential to enhance immune recognition of colorectal cancer cells, particularly in MSI Low patients who typically don't respond well to immunotherapy. This approach could potentially expand the patient population benefiting from immunotherapy.
The preclinical data published in EMBO Reports is particularly intriguing. LB-100's ability to create neoantigens by disrupting mRNA processing could be a game-changer for immunotherapy. This mechanism could potentially turn "cold" tumors "hot," making them more susceptible to immune checkpoint inhibitors. If translated to clinical settings, this could significantly improve the efficacy of existing immunotherapies across various cancer types.
The appointment of Dr. Jan Schellens as CMO is a strategic move for LIXTE. His extensive experience in drug development and clinical oncology will be invaluable in guiding LB-100 through clinical trials. His background suggests he'll bring a rigorous scientific approach to LIXTE's development programs.
The ongoing phase I trial in advanced soft tissue sarcomas, combining LB-100 with standard chemotherapy, is promising. Expected data in early 2025 will be important in determining the safety profile and potential efficacy of this combination. However, the termination of the small cell lung cancer trial at City of Hope due to low patient accrual is a setback. It highlights the challenges in patient recruitment for clinical trials, especially in competitive indications like lung cancer.
LIXTE's collaborations with major pharmaceutical companies like Roche and GSK are significant. These partnerships not only provide financial support for clinical trials but also validate the potential of LB-100. The funding of trials by these industry giants suggests a strong interest in LIXTE's technology, which could lead to future licensing deals or acquisitions.
However, investors should note that LIXTE is still in early clinical stages, with no products on the market. The company's
-Collaboration with NKI and Funding Support for New Colorectal Cancer Clinical Trial by Major Pharma Company-
-Distinguished Oncologist Jan Schellens Joins LIXTE as Chief Medical Officer-
-Preclinical Data Published in Journal EMBO Reports Shows LB-100 as Potentially Enhancing the Benefit of Immunotherapy-
-LIXTE to Present at Two Upcoming Investor Conferences-
PASADENA, CA, Aug. 19, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy, today provided an update on the Company’s recent activities.
“We are encouraged by the growing interest shown by major pharmaceutical companies in our proprietary compound, LB-100, as demonstrated by their support in clinical trial collaborations,” said Bas van der Baan, LIXTE’s President and Chief Executive Officer.
“Highlighting the Company’s recent progress is our new agreement with The Netherlands Cancer Institute, supported by F. Hoffmann- La Roche Ltd. (“Roche”), which is funding the clinical trial in metastatic colorectal cancer and providing atezolizumab (Tecentriq®, a PD-L1 inhibitor) through the imCORE network, an academic industry collaboration that aims at accelerating cancer immunotherapy research through institution sponsored studies. Already underway is a proof-of-concept trial, funded by GSK, of LB-100 plus GSK’s dostarlimab-gxly in ovarian clear cell cancer.
“We are seeing encouraging results in the first phase of our clinical trial to determine appropriate dosing and toxicity for treating advanced soft tissue sarcomas with a combination of LB-100 and standard-of-care chemotherapy and expect to see the data from this first phase early in 2025. We are exploring alternative sites, including international locations, for our small cell lung cancer trial, following termination of that clinical trial at City of Hope due to limited patient accrual,” Mr. van der Baan added.
Recent Company Highlights:
- Collaboration with the Netherlands Cancer Institute, supported by Roche, to conduct a new clinical trial (NCT06012734 in clinicaltrials.gov) in immune therapy for unresponsive (MSI Low) metastatic colorectal cancer. LIXTE is providing its lead compound, LB-100, and Roche will provide atezolizumab (Tecentriq®,a PD-L1 inhibitor). The clinical trial will test recent findings that indicate that LB-100 increases recognition of colorectal cancer cells by the immune system.
- Jan Schellens, M.D., Ph.D., joined LIXTE as Chief Medical Officer effective August 1, 2024. Dr. Schellens brings to the Company more than 25 years of clinical experience as a medical oncologist, pharmacologist and clinical pharmacologist, including more than two decades developing and bringing new drugs to market. Co-author of more 900 publications in peer-reviewed scientific journals, Dr. Schellens has held leadership positions at the Netherlands Cancer Institute in Amsterdam and the Dr. Daniel den Hoed Clinic-Erasmus University in Rotterdam. He was professor of clinical pharmacology at Utrecht University in the Netherlands, where he earned his M.D. degree, and he served as a board member and Chief Medical Officer of Byondis B.V. in Nijmegen, Netherlands. Dr. Schellens also earned a Ph.D. degree in Pharmaceutical Sciences from Leiden University in Leiden, Netherlands.
- New pre-clinical data in the journal EMBO Reports shows that LIXTE’s lead compound, LB-100, can turn immunologically “cold” tumors “hot,” potentially enhancing the benefit of immunotherapy. In a paper titled, “The Phosphatase Inhibitor LB-100 Creates Neoantigens in Colon Cancer Cells through Perturbation of mRNA Splicing,” the article reported that LIXTE’s collaborators from the Netherlands Cancer Institute have demonstrated that treatment of cancer cells with LB-100 disrupts the normal processing of the mRNA that encodes proteins, thereby generating neo-antigens that are presented to the host immune system. This new mechanism adds to several previous discoveries showing that LB-100 sensitizes cancer cells to immune checkpoint blockade.
- LIXTE will present at two upcoming investor conferences: the 2004 Summit Summer 2024 Virtual Conference, August 20, 2024, and the H.C. Wainwright 26th Annual Global Investor Conference, September 9-11, 2024. Both conferences will be virtual presentations.
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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