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TCBP Announces H5N1 Proof of Concept Studies Intention

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TC BioPharm (NASDAQ: TCBP) announced plans to initiate Proof of Concept preclinical studies for its lead therapeutic TCB008 to treat H5N1 (Bird Flu). The company is seeking university partnerships to accelerate preclinical work needed for Phase I studies. TCB008 is an allogeneic, unmodified cell therapy composed of activated and expanded gamma delta T cells, which the company believes could help address the emerging avian bird flu epidemic.

The announcement follows the first reported U.S. death from H5N1 by the Louisiana Department of Health. H5N1 is a viral infection typically contracted through contact with infected birds but can spread between humans, with symptoms appearing within 2-8 days, resembling common flu symptoms and potentially carrying high mortality rates in humans.

TC BioPharm (NASDAQ: TCBP) ha annunciato piani per avviare studi préclinici di Proof of Concept per il suo principale terapeutico TCB008 per trattare l'H5N1 (Influenza Aviaria). L'azienda sta cercando partnership con università per accelerare il lavoro préclinico necessario per gli studi di Fase I. TCB008 è una terapia cellulare allogenica e non modificata composta da cellule T gamma delta attivate ed espanse, di cui l'azienda crede possano aiutare a far fronte all'emergente epidemia di influenza aviaria.

L'annuncio segue la prima morte negli Stati Uniti riportata dall'H5N1 da parte del Dipartimento della Salute della Louisiana. L'H5N1 è un'infezione virale tipicamente contratta attraverso il contatto con uccelli infetti, ma può diffondersi tra gli esseri umani, con sintomi che appaiono entro 2-8 giorni, somigliando a sintomi influenzali comuni e potenzialmente portando a tassi di mortalità elevati negli esseri umani.

TC BioPharm (NASDAQ: TCBP) anunció planes para iniciar estudios preclínicos de Prueba de Concepto para su terapia líder TCB008 para tratar el H5N1 (Gripe Aviar). La empresa está buscando asociaciones con universidades para acelerar el trabajo preclínico necesario para los estudios de Fase I. TCB008 es una terapia celular alogénica y no modificada compuesta por células T gamma delta activadas y expandidas, que la compañía cree que podrían ayudar a abordar la evolución de la epidemia de gripe aviar.

El anuncio sigue a la primera muerte reportada en EE. UU. por H5N1 por parte del Departamento de Salud de Luisiana. El H5N1 es una infección viral que se contrae típicamente a través del contacto con aves infectadas, pero que puede transmitirse entre humanos, con síntomas que aparecen dentro de 2-8 días, que se asemejan a los síntomas de la gripe común y que potencialmente llevan a tasas de mortalidad altas en humanos.

TC BioPharm (NASDAQ: TCBP)는 H5N1(조류 인플루엔자) 치료를 위한 주요 치료제 TCB008의 개념 증명(preclinical) 연구를 시작할 계획을 발표했습니다. 회사는 1상 연구에 필요한 전임상 작업을 가속화하기 위해 대학과의 파트너십을 모색하고 있습니다. TCB008은 활성화되고 확장된 감마 델타 T세포로 구성된 변경되지 않은 동종 세포 치료제로, 회사는 이 치료가 새롭게 떠오르는 조류 인플루엔자 전염병에 대응하는 데 도움이 될 것이라고 믿고 있습니다.

이 발표는 루이지애나 보건부에서 보고한 H5N1에 의한 미국 내 첫 사망 사건에 이어 나온 것입니다. H5N1은 일반적으로 감염된 새와의 접촉을 통해 전염되는 바이러스 감염이지만, 인간 간에도 전파될 수 있으며, 2-8일 이내에 증상이 나타나고 일반 감기 증상과 유사하며 인간의 높은 사망률을 초래할 수 있습니다.

TC BioPharm (NASDAQ: TCBP) a annoncé des plans pour initier des études précliniques de preuve de concept pour son traitement phare TCB008 destiné à traiter l'H5N1 (Grippe aviaire). L'entreprise recherche des partenariats universitaires pour accélérer le travail préclinique nécessaire aux études de Phase I. TCB008 est une thérapie cellulaire allogénique, non modifiée, composée de cellules T gamma delta activées et étendues, que l'entreprise pense pouvoir aider à faire face à l'épidémie émergente de grippe aviaire.

L'annonce fait suite au premier décès signalé aux États-Unis dû à l'H5N1, selon le département de la santé de la Louisiane. L'H5N1 est une infection virale généralement contractée par contact avec des oiseaux infectés, mais qui peut se propager entre humains, avec des symptômes apparaissant dans les 2 à 8 jours, ressemblant à des symptômes de grippe commune et pouvant potentiellement entraîner des taux de mortalité élevés chez les humains.

TC BioPharm (NASDAQ: TCBP) hat Pläne angekündigt, vorklinische Studien zur Konzeptbestätigung für seine führende Therapie TCB008 zur Behandlung von H5N1 (Vogelgrippe) zu starten. Das Unternehmen sucht nach Partnerschaften mit Universitäten, um die benötigten vorklinischen Arbeiten für die Phase-I-Studien zu beschleunigen. TCB008 ist eine allogenetische, nicht modifizierte Zelltherapie, die aus aktivierten und expandierten Gamma-Delta-T-Zellen besteht, von denen das Unternehmen glaubt, dass sie helfen könnten, die aufkommende Epidemie der Vogelgrippe zu bekämpfen.

Die Ankündigung folgt dem ersten gemeldeten Todesfall in den USA durch H5N1, wie vom Gesundheitsministerium von Louisiana berichtet. H5N1 ist eine Virusinfektion, die typischerweise durch den Kontakt mit infizierten Vögeln erworben wird, sich jedoch auch zwischen Menschen verbreiten kann, wobei die Symptome innerhalb von 2-8 Tagen auftreten, ähnlich wie bei typischen Grippesymptomen, und potenziell hohe Sterblichkeitsraten bei Menschen verursachen kann.

Positive
  • Expansion into infectious disease vertical with TCB008
  • Potential new market opportunity in H5N1 treatment
  • Strategic pursuit of university partnerships to accelerate development
Negative
  • Early-stage research with no guaranteed success
  • Additional resources required for new indication development
  • Competitive market with existing antiviral treatments

Insights

The announcement of H5N1 proof-of-concept studies for TCB008 represents a strategic pivot but faces significant hurdles. While gamma-delta T cell therapies show promise in cancer treatment, their application to viral infections like H5N1 remains largely theoretical. The key technical challenges include:

  • Demonstrating effective viral clearance in preclinical models
  • Establishing a viable therapeutic window given H5N1's rapid progression
  • Addressing manufacturing and distribution logistics for an acute infectious disease

With a market cap of just $4.35M, TCBP lacks the resources for independent development. The company's strategy to partner with academic institutions is practical but may significantly delay development timelines. The recent U.S. H5N1 fatality creates urgency, but transitioning from oncology to infectious diseases requires substantial regulatory and clinical validation. Competition from established antivirals and potential vaccines presents significant market entry barriers.

This announcement carries minimal immediate financial impact but introduces significant operational risks. The company's micro-cap status ($4.35M) raises serious concerns about funding capacity for new indication development. Critical financial considerations include:

  • Substantial R&D costs for preclinical studies without guaranteed returns
  • Dilution risks from potential capital raises needed to fund development
  • bargaining power in potential university partnerships

The pivot to infectious diseases could diversify the pipeline but stretches already thin resources. While the H5N1 angle may attract speculative interest, the company's fundamental financial constraints remain unchanged. The lack of defined timelines or committed partnerships suggests this is more exploratory than material at this stage.

EDINBURGH, Scotland, Jan. 15, 2025 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced that it intends to begin Proof of Concept preclinical studies for its lead therapeutic TCB008, for treatment in H5N1, commonly known as "Bird Flu." The Company is currently approaching potential university partners to expedite the preclinical work required for a Phase I study.

H5N1 is a viral infection often contracted by contact with sick birds, yet it can also be passed from person to person. Symptoms begin within two to eight days and can seem like the common flu, causing cough, fever, sore throat, muscle aches, headache, and shortness of breath. The disease can carry a high mortality in humans. Some antiviral drugs, if taken within two days of symptoms, may help. Last week, the Louisiana Department of Health recently reported the first U.S. death from H5N1.

TCB008 is an allogeneic, unmodified cell therapy made up of activated and expanded gamma delta T (GDT) cells, which the company expects will have applications in treating the emerging avian bird flu epidemic. Due to the highly infectious nature of H5N1, TC BioPharm's goal would be to partner with a leading Infectious Disease Center or University to advance the Proof-of-Concept and pre-clinical studies.

"As we have continually noted, we believe that our lead therapeutic TCB008 has tremendous potential in treating a host of diseases and infections due to its function within the immune system," said Bryan Kobel, CEO of TC BioPharm. "This endeavor further marks TCBP's intent to expand into indications in the Infectious Disease vertical, with several Proof of Concept studies planned in multiple infectious diseases. With the U.S. already incurring its first fatality and additional cases now confirmed, we want to be aggressive in working towards a treatment."

About TC BioPharm (Holdings) PLC

TC BioPharm is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing gamma-delta T-cell therapies for cancer treatment with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue.

TC BioPharm is the leader in developing gamma-delta T cell therapies and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial in the treatment of acute myeloid leukemia using the Company's proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.

Forward-Looking Statements for TC BioPharm

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Company's intent or ability to affect any budget savings or execute on any M&A or capital raising strategy. These statements are based on management's current assumptions and are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. For other important factors that could cause actual results to differ materially from the forward-looking statements in this Current Report on Form 8-K, please see the risks and uncertainties identified under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, and our other reports filed with the SEC, all of which is available on the Company's Investor Relations website at www.tcbiopharm.com and on the SEC website at www.sec.gov. All forward-looking statements reflect the Company's beliefs and assumptions only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to update forward-looking statements to reflect future events or circumstances.

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SOURCE TC BioPharm

FAQ

What is TC BioPharm's plan for H5N1 treatment with TCB008?

TC BioPharm plans to begin Proof of Concept preclinical studies for TCB008, their lead therapeutic, to treat H5N1 (Bird Flu), seeking university partnerships to expedite preclinical work for Phase I studies.

How does TCBP's TCB008 therapy work against H5N1?

TCB008 is an allogeneic, unmodified cell therapy consisting of activated and expanded gamma delta T cells, which the company believes can help treat H5N1 through immune system function.

What triggered TCBP's decision to study H5N1 treatment?

The decision follows the first U.S. death from H5N1 reported by the Louisiana Department of Health and the emergence of additional confirmed cases.

What stage is TCBP's H5N1 treatment development currently in?

The treatment is in pre-clinical planning stages, with the company seeking partnerships to begin Proof of Concept studies before advancing to Phase I clinical trials.

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Biotechnology
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