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Tevogen Bio Provides Additional Guidance on Introduction of T Cell Therapy for Oncology and Specialty Care Therapeutic Areas

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Tevogen Bio (Nasdaq: TVGN) has provided additional guidance on TVGN 489, the first clinical product of their ExacTcell™ technology. The therapy is designed to treat SARS-CoV-2 infections in immunocompromised oncology patients and certain PASC patients. The company plans market entry by end of 2026. The pipeline includes treatments for various cancers (TVGN 920 for cervical cancer prevention, TVGN 930 for EBV-associated lymphomas, TVGN 960 for mouth and throat cancer) and multiple sclerosis (TVGN 601). TVGN 489's development was achieved at lower costs compared to industry standards, and positive clinical trial results have been reported.

Tevogen Bio (Nasdaq: TVGN) ha fornito ulteriori indicazioni su TVGN 489, il primo prodotto clinico della loro tecnologia ExacTcell™. La terapia è progettata per trattare le infezioni da SARS-CoV-2 in pazienti oncologici immunocompromessi e in alcuni pazienti con PASC. L'azienda prevede di entrare nel mercato entro la fine del 2026. Il portafoglio include trattamenti per varie forme di cancro (TVGN 920 per la prevenzione del cancro cervicale, TVGN 930 per linfomi associati a EBV, TVGN 960 per il cancro della bocca e della gola) e per sclerosi multipla (TVGN 601). Lo sviluppo di TVGN 489 è stato realizzato a costi inferiori rispetto agli standard del settore, e sono stati riportati risultati positivi nei trial clinici.

Tevogen Bio (Nasdaq: TVGN) ha proporcionado orientaciones adicionales sobre TVGN 489, el primer producto clínico de su tecnología ExacTcell™. La terapia está diseñada para tratar infecciones por SARS-CoV-2 en pacientes oncológicos inmunocomprometidos y en ciertos pacientes con PASC. La empresa planea ingresar al mercado a finales de 2026. La cartera incluye tratamientos para varios tipos de cáncer (TVGN 920 para la prevención del cáncer de cuello uterino, TVGN 930 para linfomas asociados a EBV, TVGN 960 para cáncer de boca y garganta) y esclerosis múltiple (TVGN 601). El desarrollo de TVGN 489 se logró a costos más bajos en comparación con los estándares de la industria, y se han reportado resultados positivos en los ensayos clínicos.

Tevogen Bio (Nasdaq: TVGN)는 그들의 ExacTcell™ 기술의 첫 번째 임상 제품인 TVGN 489에 대한 추가 지침을 제공했습니다. 이 요법은 면역이 저하된 종양학 환자와 특정 PASC 환자의 SARS-CoV-2 감염 치료를 위해 설계되었습니다. 회사는 2026년 말까지 시장에 진입할 계획입니다. 파이프라인에는 여러 종류의 암에 대한 치료제(TVGN 920은 자궁경부암 예방, TVGN 930은 EBV 관련 림프종, TVGN 960은 구강 및 인두암에 대한 치료제)와 다발성 경화증(TVGN 601)가 포함되어 있습니다. TVGN 489의 개발은 업계 표준에 비해 낮은 비용으로 이루어졌으며, 긍정적인 임상 시험 결과가 보고되었습니다.

Tevogen Bio (Nasdaq: TVGN) a fourni des indications supplémentaires sur TVGN 489, le premier produit clinique de leur technologie ExacTcell™. Ce traitement est conçu pour traiter les infections par SARS-CoV-2 chez des patients en oncologie immunodéprimés et chez certains patients atteints de PASC. L'entreprise prévoit une entrée sur le marché d'ici fin 2026. Le pipeline comprend des traitements pour divers cancers (TVGN 920 pour la prévention du cancer du col de l'utérus, TVGN 930 pour les lymphomes associés à EBV, TVGN 960 pour le cancer de la bouche et de la gorge) et pour la sclérose en plaques (TVGN 601). Le développement de TVGN 489 a été réalisé à des coûts inférieurs à ceux des normes de l'industrie, et des résultats positifs des essais cliniques ont été rapportés.

Tevogen Bio (Nasdaq: TVGN) hat weitere Hinweise zu TVGN 489, dem ersten klinischen Produkt ihrer ExacTcell™-Technologie, gegeben. Die Therapie ist darauf ausgelegt, SARS-CoV-2-Infektionen bei immunokompromittierten Krebspatienten und bestimmten PASC-Patienten zu behandeln. Das Unternehmen plant den Markteintritt bis Ende 2026. Die Pipeline umfasst Behandlungen für verschiedene Krebsarten (TVGN 920 zur Prävention von Gebärmutterhalskrebs, TVGN 930 für EBV-assoziierte Lymphome, TVGN 960 für Mund- und Rachenkrebs) und multiple Sklerose (TVGN 601). Die Entwicklung von TVGN 489 wurde zu niedrigeren Kosten im Vergleich zu den Branchenstandards erreicht, und es wurden positive Ergebnisse aus klinischen Studien berichtet.

Positive
  • Positive clinical trial results for TVGN 489
  • Cost-effective development achieved below industry norms
  • Clear market entry timeline set for end of 2026
  • Diverse pipeline covering multiple therapeutic areas
Negative
  • None.

Insights

This pipeline update from Tevogen Bio reveals strategic positioning in T cell therapeutics, focusing on TVGN 489 for immunocompromised patients. The planned 2026 market entry timeline and expanded pipeline targeting multiple indications show promising development trajectory. However, several critical elements are missing from this announcement:

  • No specific clinical trial data or efficacy metrics provided
  • Absence of financial details or development costs
  • No concrete regulatory milestones or FDA submission timeline
  • Lack of market size estimates for target indications

The company's claim of cost-effective development "at a fraction of industry norms" requires substantiation with actual figures. While the pipeline diversity across oncology and autoimmune conditions is noteworthy, investors should await more concrete data and regulatory progress before drawing conclusions about commercial viability.

WARREN, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio (“Tevogen” or “Tevogen Bio Holdings Inc.”) (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech developing off-the-shelf, genetically unmodified T cell therapeutics to treat infectious disease and cancers, today provided additional guidance on the first clinical product of the company’s proprietary ExacTcell™ technology, TVGN 489, designed to treat SARS-CoV-2 infections in immunocompromised oncology patients, and a subgroup of patients with post-acute sequelae of SARS-CoV-2 (PASC).

Tevogen Bio’s recently shared forecast reflects its business plan of market entry by the end of 2026.

“The rapid and cost-effective development of TVGN 489, achieved at a fraction of industry norms, strengthens my confidence in Tevogen’s innovative business model,” remarked Ryan Saadi, MD, MPH, Founder and CEO of Tevogen Bio, Nobel Peace Prize nominee, inventor of ExacTcell. “The positive clinical trial underscores TVGN 489’s potential, and it is my personal commitment that the company will do everything in its power to speed up the development process. I am pleased that the company was able to make progress to bridge any information gap and look forward to sharing other achievements in the coming weeks, particularly on the progress of Tevogen.AI.”

Pipeline

  • TVGN 489:
    • Treatment of SARS-CoV-2 infection in patients with B cell hematologic cancer
      [part of Tevogen Bio Oncology forecast]
    • Treatment of SARS-CoV-2 infection in patients with other cancers
      [part of Tevogen Bio Oncology forecast]
    • SARS-CoV-2 infection in patients under treatment for rheumatoid arthritis
    • SARS-CoV-2 infection in patients under treatment for and psoriatic arthritis
    • Treatment of Long COVID [part of Tevogen Bio Specialty Care forecast]
  • TVGN 920: Cervical cancer prevention
  • TVGN 930: EBV-associated lymphomas
  • TVGN 960: Mouth and throat cancer
  • TVGN 601: Multiple sclerosis

About Tevogen Bio

Tevogen is a clinical-stage specialty immunotherapy company harnessing CD8+ cytotoxic T lymphocytes, to develop off-the-shelf, genetically unmodified T cell therapeutics to treat infectious disease and cancers, aiming to address the significant unmet needs of large patient populations. Tevogen leadership believes that sustainability and commercial success in the current era of healthcare rely on ensuring patient accessibility through advanced science and innovative business models. Tevogen has reported positive safety data from its proof-of-concept clinical trial, and its key intellectual property assets are wholly owned by the company, not subject to any third-party licensing agreements. These assets include three granted patents and numerous pending patents, two of which are related to artificial intelligence.

Tevogen is driven by a team of experienced industry leaders and scientists with drug development and global product launch experience. Tevogen’s leadership believes that accessible personalized therapeutics are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation.

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: expectations regarding the healthcare and biopharmaceutical industries; Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases, cancer and neurological disorders, including TVGN 489 for the treatment of COVID-19 and Long COVID; Tevogen’s ability to develop additional product candidates, including through use of Tevogen’s ExacTcell platform; the anticipated benefits of ExacTcell; expectations regarding Tevogen’s future clinical trials; and Tevogen’s ability to generate revenue in the future. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.

Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; the effect of the recent business combination with Semper Paratus Acquisition Corporation (the “Business Combination”) on Tevogen’s business relationships, operating results, and business generally; the outcome of any legal proceedings that may be instituted against Tevogen; changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; costs related to the Business Combination and the failure to realize anticipated benefits of the Business Combination; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; the ability to develop, license or acquire new therapeutics; that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K and subsequent filings with the SEC.

You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.

Contacts

Tevogen Bio Communications
T: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com


FAQ

When will Tevogen Bio (TVGNW) launch TVGN 489 to market?

According to the company's forecast, Tevogen Bio plans to launch TVGN 489 to market by the end of 2026.

What conditions will TVGN 489 treat?

TVGN 489 is designed to treat SARS-CoV-2 infections in immunocompromised oncology patients and certain patients with post-acute sequelae of SARS-CoV-2 (PASC).

What are the key products in Tevogen Bio's pipeline?

Tevogen's pipeline includes TVGN 489 for COVID-19, TVGN 920 for cervical cancer prevention, TVGN 930 for EBV-associated lymphomas, TVGN 960 for mouth and throat cancer, and TVGN 601 for multiple sclerosis.

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Biotechnology
Biological Products, (no Disgnostic Substances)
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