LIXTE Biotechnology Provides Update On Progress with Proprietary Compound, LB-100, to Treat Ovarian and Colorectal Cancer
LIXTE Biotechnology (LIXT) has announced significant progress in its cancer treatment development programs. The company has initiated two new clinical trials for its lead compound LB-100: a Phase 1b/2 trial combining LB-100 with GSK's dostarlimab-gxly for ovarian clear cell carcinoma, and a trial with the Netherlands Cancer Institute and Roche for unresponsive metastatic colorectal cancer.
Key developments include successful patient dosing in both trials, receipt of a USPTO Notice of Allowance for combining LB-100 with cancer immunotherapies, and completion of a $1,050,000 registered direct offering. Two breakthrough studies were published: one in Cancer Discovery showing LB-100's ability to force cancer cells to relinquish malignant properties, and another in EMBO demonstrating how LB-100 makes cancer cells more vulnerable to immunotherapy.
LIXTE Biotechnology (LIXT) ha annunciato progressi significativi nei suoi programmi di sviluppo per il trattamento del cancro. L'azienda ha avviato due nuovi studi clinici per il suo composto principale LB-100: uno studio di fase 1b/2 che combina LB-100 con il dostarlimab-gxly di GSK per il carcinoma a cellule chiare dell'ovaio, e uno studio con l'Istituto Nazionale dei Tumori dei Paesi Bassi e Roche per il carcinoma colorettale metastatico non responsivo.
I principali sviluppi includono il dosaggio riuscito dei pazienti in entrambi gli studi, la ricezione di un Avviso di Concessione USPTO per la combinazione di LB-100 con le immunoterapie contro il cancro, e il completamento di un'offerta diretta registrata di 1.050.000 dollari. Sono stati pubblicati due studi rivoluzionari: uno su Cancer Discovery che mostra la capacità di LB-100 di costringere le cellule tumorali a rinunciare alle proprietà maligne, e un altro su EMBO che dimostra come LB-100 renda le cellule tumorali più vulnerabili all'immunoterapia.
LIXTE Biotechnology (LIXT) ha anunciado avances significativos en sus programas de desarrollo de tratamientos contra el cáncer. La empresa ha iniciado dos nuevos ensayos clínicos para su compuesto líder LB-100: un ensayo de fase 1b/2 que combina LB-100 con el dostarlimab-gxly de GSK para el carcinoma de células claras de ovario, y un ensayo con el Instituto del Cáncer de los Países Bajos y Roche para el cáncer colorrectal metastásico no respondido.
Los desarrollos clave incluyen la dosificación exitosa de pacientes en ambos ensayos, la recepción de un Aviso de Concesión de la USPTO para combinar LB-100 con inmunoterapias contra el cáncer, y la finalización de una oferta directa registrada de 1.050.000 dólares. Se publicaron dos estudios innovadores: uno en Cancer Discovery que muestra la capacidad de LB-100 para forzar a las células cancerosas a renunciar a propiedades malignas, y otro en EMBO que demuestra cómo LB-100 hace que las células cancerosas sean más vulnerables a la inmunoterapia.
LIXTE Biotechnology (LIXT)는 암 치료 개발 프로그램에서 중요한 진전을 발표했습니다. 이 회사는 주요 화합물 LB-100에 대해 두 개의 새로운 임상 시험을 시작했습니다: GSK의 dostarlimab-gxly와 LB-100을 결합한 난소 투명 세포 암을 위한 1b/2상 시험과, 네덜란드 암 연구소 및 로슈와 협력하여 비반응성 전이성 대장암을 위한 시험입니다.
주요 개발 사항으로는 두 시험 모두에서 환자 투여의 성공, 암 면역 치료제와 LB-100의 결합에 대한 USPTO 허가 통지 수령, 1,050,000달러의 등록 직접 제안 완료가 포함됩니다. 두 가지 혁신적인 연구가 발표되었습니다: 하나는 Cancer Discovery에 게재되어 LB-100이 암 세포가 악성 특성을 포기하도록 강요하는 능력을 보여주었고, 다른 하나는 EMBO에서 LB-100이 암 세포를 면역 치료에 더 취약하게 만드는 방법을 입증했습니다.
LIXTE Biotechnology (LIXT) a annoncé des progrès significatifs dans ses programmes de développement de traitements contre le cancer. L'entreprise a lancé deux nouveaux essais cliniques pour son composé phare LB-100 : un essai de phase 1b/2 combinant LB-100 avec le dostarlimab-gxly de GSK pour le carcinome à cellules claires de l'ovaire, et un essai avec l'Institut néerlandais du cancer et Roche pour le cancer colorectal métastatique non réactif.
Les développements clés incluent la réussite du dosage des patients dans les deux essais, la réception d'un Avis de Concession de l'USPTO pour la combinaison de LB-100 avec des immunothérapies contre le cancer, et l'achèvement d'une offre directe enregistrée de 1 050 000 dollars. Deux études révolutionnaires ont été publiées : l'une dans Cancer Discovery montrant la capacité de LB-100 à contraindre les cellules cancéreuses à renoncer à leurs propriétés malignes, et l'autre dans EMBO démontrant comment LB-100 rend les cellules cancéreuses plus vulnérables à l'immunothérapie.
LIXTE Biotechnology (LIXT) hat bedeutende Fortschritte in seinen Entwicklungsprogrammen für Krebsbehandlungen bekannt gegeben. Das Unternehmen hat zwei neue klinische Studien für seinen Hauptbestandteil LB-100 initiiert: eine Phase 1b/2-Studie, die LB-100 mit dem Dostarlimab-gxly von GSK für das Ovarialkarzinom mit klaren Zellen kombiniert, und eine Studie mit dem Niederländischen Krebsinstitut und Roche für unempfindliches metastatisches kolorektales Karzinom.
Zu den wichtigsten Entwicklungen gehören die erfolgreiche Dosierung von Patienten in beiden Studien, der Erhalt einer USPTO-Zulassungsmitteilung für die Kombination von LB-100 mit Krebsimmuntherapien und der Abschluss eines registrierten Direktangebots über 1.050.000 US-Dollar. Zwei bahnbrechende Studien wurden veröffentlicht: eine in Cancer Discovery, die zeigt, dass LB-100 in der Lage ist, Krebszellen dazu zu bringen, bösartige Eigenschaften aufzugeben, und eine andere in EMBO, die demonstriert, wie LB-100 Krebszellen anfälliger für Immuntherapien macht.
- Initiated two new clinical trials with major partners GSK and Roche
- Received USPTO patent allowance for LB-100 immunotherapy combinations
- Secured $1.05M in new funding through direct offering
- Published positive results in two prestigious medical journals
- Additional funding needed as indicated by new $1.05M offering
- Early-stage clinical trials indicate long path to potential commercialization
Insights
LIXTE's clinical progress with LB-100 represents a compelling approach to addressing treatment-resistant cancers. The mechanism of forcing cancer cells to create neo-antigens and relinquish malignant properties offers a distinct therapeutic strategy with significant potential in immunotherapy enhancement. This approach tackles a major challenge in oncology – tumors that evade immune recognition.
The collaboration with MD Anderson and Northwestern University for ovarian cancer trials, supported by GSK's dostarlimab-gxly (a PD-1 inhibitor), targets clear cell ovarian carcinoma – a notoriously difficult-to-treat subtype with therapeutic options. Similarly, partnering with the Netherlands Cancer Institute and Roche to address microsatellite stable (MSI Low) metastatic colorectal cancer addresses another significant unmet need, as these tumors typically respond poorly to immunotherapy alone.
The publications in Cancer Discovery and EMBO provide critical scientific validation. These peer-reviewed journals represent top-tier platforms in cancer research, suggesting that LB-100's mechanism has garnered serious scientific interest. The ability to modulate immune response through oxabicycloheptanes (now patent-protected) may offer a platform technology applicable across multiple immunotherapy combinations.
While these developments represent early-stage clinical work, the multi-institutional approach and pharmaceutical partnerships suggest a well-designed development strategy for targeting challenging cancer subtypes with a novel mechanism of action.
LIXTE's clinical progress demonstrates strategic execution on multiple fronts for its lead compound. The company has successfully launched key clinical trials, secured additional intellectual property protection, and raised modest funding while establishing significant pharmaceutical partnerships.
The collaborations with GSK and Roche represent particularly valuable external validation. Major pharmaceutical companies typically conduct extensive due diligence before supporting early-stage compounds, suggesting LB-100's mechanism has generated serious interest. These partnerships can potentially reduce development costs while providing expertise in regulatory navigation and eventual commercialization pathways.
The USPTO Notice of Allowance strengthens LIXTE's competitive position by protecting LB-100's combination with various immunotherapies - crucial for a platform-type technology. This patent protection enhances potential partnership and licensing opportunities.
The
The scientific publications in prestigious journals add considerable credibility to LB-100's mechanism of action. For micro-cap biotechs, this third-party validation helps differentiate serious scientific approaches from more speculative ventures.
While still early-stage with inherent development risks, LIXTE has assembled the essential components for clinical advancement: institutional partnerships, scientific validation, intellectual property protection, and pharmaceutical company support - creating multiple potential value inflection points as these trials progress.
-Started Two New Clinical Trials, Collaborating with MD Anderson and The Netherlands Cancer Institute for Treatment of Ovarian and Colorectal Cancer-
-Received Exclusive Patent License Agreement with the NIH
on LB-100's Potential in Enhancing Cancer Immunotherapies-
-Two Breakthrough Publications in Medical Journals, EMBO and Cancer Discovery,
Supporting LIXTE’s Clinical Trial Program-
PASADENA, Calif, March 27, 2025 (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 its recent activities.
“Continued progress has been made in collaborative clinical studies with two global pharmaceutical companies for our lead proprietary compound, LB-100, to treat ovarian and colorectal cancer,” said Bas van der Baan, LIXTE’s President and Chief Executive Officer. “We are encouraged that LB-100 has been found to be well tolerated in clear cell ovarian cancer patients at doses with anti-cancer activity, underscoring our mission and commitment to deliver effective solutions to patients battling cancer.
“LIXTE trials are underway for ovarian cancer at the M.D. Anderson Cancer Center and at Northwestern University, supported by GSK. Our colorectal trial, supported by F. Hoffmann-La Roche, is being conducted at the Netherlands Cancer Institute,” Mr. van der Baan added.
Recent LIXTE Highlights Include:
- The first patient dosing in a Phase 1b/2 trial combining LIXTE's LB-100 with GSK's immunotherapy, dostarlimab-gxly, targeting ovarian clear cell carcinoma.
- 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.
- Further bolstering of LIXTE’s intellectual property portfolio, with receipt of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent application number 16/467,721, titled, "Oxabicycloheptanes for Modulation of Immune Response,” for combining the Company’s LB-100 compound with various innovative cancer immunotherapies.
- Completion of a registered direct offering, raising aggregate gross proceeds of approximately
$1,050,000 t o be used for working capital and other general corporate purposes.
- Study published in Cancer Discovery, revealing that LB-100 can force cancer cells to relinquish their malignant properties, suggesting a novel therapeutic approach.
- Study published in EMBO, highlighting how LB-100 forces cancer cells to create neo antigens and make them more vulnerable for 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, LB-100 has the potential to significantly improve outcomes for patients undergoing various chemotherapies or immunotherapies. LIXTE's new approach has no known competitors and is covered by a comprehensive patent portfolio. Proof-of-concept clinical trials are in progress. 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. Additional information about LIXTE can be found at www.lixte.com and in the Company’s Annual Report on Form 10-K for year ended December 31, 2024, which has been filed with the U.S. Securities and Exchange Commission at www.sec.gov.
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 are the two new clinical trials LIXT has started for LB-100?
How much funding did LIXT raise in its recent direct offering?
What did the recent Cancer Discovery study reveal about LIXT's LB-100?
What new patent allowance did LIXT receive for LB-100?
