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CytoDyn Announces Abstract that Highlights Leronlimab’s Potential in Mediating ART-Free Viral Control in Infant Rhesus Macaques

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CytoDyn Inc. (OTCQB: CYDY) announced the acceptance of an abstract for presentation at the 5th annual HIV Research for Prevention Conference. The abstract highlights research on combining early antiretroviral therapy (ART) with broadly neutralizing antibodies (bNAbs) and leronlimab, a CCR5 antagonist, in infant rhesus macaques infected with Simian Human Immunodeficiency Virus (SHIV).

Key findings include:

  • The study aimed to assess if this combination could provide sustained viral control without continuous ART
  • 18 infant rhesus macaques were treated with various combinations of ART, bNAbs, and leronlimab
  • No virus rebound was observed in treated animals over a 27-week period
  • Results suggest potential for durable viral control and reduced need for ongoing ART

The study, funded by an NIH grant to OHSU, will be presented by Dr. Jonah B. Sacha at the conference in Lima, Peru on October 10, 2024.

CytoDyn Inc. (OTCQB: CYDY) ha annunciato l'accettazione di un'astratto per la presentazione alla 5ª Conferenza Annuale sulla Ricerca per la Prevenzione dell'HIV. L'astratto mette in evidenza la ricerca sulla combinazione della terapia antiretrovirale precoce (ART) con anticorpi neutralizzanti ampi (bNAbs) e leronlimab, un antagonista del CCR5, in macachi rhesus neonati infettati dal Virus dell'Immunodeficienza Umana Simiana (SHIV).

I principali risultati includono:

  • Lo studio mirava a valutare se questa combinazione potesse fornire un controllo virale sostenuto senza una continua ART
  • 18 macachi rhesus neonati sono stati trattati con varie combinazioni di ART, bNAbs e leronlimab
  • Non sono stati osservati rimbalzi virali negli animali trattati durante un periodo di 27 settimane
  • I risultati suggeriscono un potenziale per un controllo virale duraturo e una ridotta necessità di ART continua

Lo studio, finanziato da un grant NIH all'OHSU, sarà presentato dal Dr. Jonah B. Sacha alla conferenza a Lima, in Perù, il 10 ottobre 2024.

CytoDyn Inc. (OTCQB: CYDY) anunció la aceptación de un resumen para su presentación en la 5ª Conferencia Anual de Investigación sobre Prevención del VIH. El resumen destaca la investigación sobre la combinación de la terapia antirretroviral temprana (ART) con anticuerpos neutralizantes amplios (bNAbs) y leronlimab, un antagonista de CCR5, en macacos rhesus lactantes infectados con el Virus de Inmunodeficiencia Simiana Humana (SHIV).

Los hallazgos clave incluyen:

  • El estudio tenía como objetivo evaluar si esta combinación podría proporcionar un control viral sostenido sin ART continuo
  • Se trató a 18 macacos rhesus lactantes con varias combinaciones de ART, bNAbs y leronlimab
  • No se observó rebote viral en los animales tratados durante un periodo de 27 semanas
  • Los resultados sugieren un potencial para un control viral duradero y una menor necesidad de ART continua

El estudio, financiado por una subvención de los NIH a la OHSU, será presentado por el Dr. Jonah B. Sacha en la conferencia en Lima, Perú, el 10 de octubre de 2024.

CytoDyn Inc. (OTCQB: CYDY)는 제5회 HIV 예방 연구 회의에서 발표를 위한 초록의 수락을 발표했습니다. 이 초록은 광범위 중화항체(bNAbs) 및 CCR5의 길항제인 레론리맙과 함께 조기 항레트로바이러스 요법(ART)의 조합에 대한 연구를 강조합니다. 이 연구는 인간 면역결핍 바이러스(SHIV)에 감염된 유아 롯바키 원숭이를 대상으로 수행되었습니다.

주요 발견 사항은 다음과 같습니다:

  • 이 연구는 이러한 조합이 지속적인 ART 없이도 지속적인 바이러스 조절을 제공할 수 있는지를 평가하는 것을 목표로 했습니다.
  • 18마리의 유아 롯바키 원숭이가 다양한 ART, bNAbs 및 레론리맙 조합으로 치료 받았습니다.
  • 치료된 동물에서는 27주 동안 바이러스 반등이 관찰되지 않았습니다.
  • 결과는 지속적인 바이러스 조절 가능성과 지속적인 ART 필요성 감소를 시사합니다.

이 연구는 NIH의 OHSU에 대한 보조금으로 자금을 지원받았으며 2024년 10월 10일 페루 리마에서 열리는 회의에서 Dr. Jonah B. Sacha가 발표할 예정입니다.

CytoDyn Inc. (OTCQB: CYDY) a annoncé l'acceptation d'un résumé pour présentation lors de la 5e Conférence Annuelle sur la Recherche pour la Prévention du VIH. Le résumé met en évidence une recherche sur la combinaison de la thérapie antirétrovirale précoce (ART) avec des anticorps neutralisants larges (bNAbs) et leronlimab, un antagoniste CCR5, chez des macaques rhésus nouveau-nés infectés par le Virus Simien de l'Immunodéficience Humaine (SHIV).

Les principales conclusions comprennent :

  • L'étude visait à évaluer si cette combinaison pouvait fournir un contrôle viral durable sans ART continu
  • 18 macaques rhésus nouveaux-nés ont été traités avec diverses combinaisons d'ART, bNAbs et leronlimab
  • Aucun rebond viral n'a été observé chez les animaux traités sur une période de 27 semaines
  • Les résultats suggèrent un potentiel pour un contrôle viral durable et une réduction des besoins en ART continue

L'étude, financée par une subvention des NIH à l'OHSU, sera présentée par le Dr Jonah B. Sacha lors de la conférence à Lima, au Pérou, le 10 octobre 2024.

CytoDyn Inc. (OTCQB: CYDY) gab die Annahme eines Abstracts zur Präsentation auf der 5. jährlichen HIV-Forschungskonferenz zur Prävention bekannt. Das Abstract hebt die Forschung zur Kombination einer frühen antiretroviralen Therapie (ART) mit breit neutralisierenden Antikörpern (bNAbs) und Leronlimab, einem CCR5-Antagonisten, bei infizierten Säugungsmakaken von Rhesusaffen mit dem Simianen Humanen Immunodeficiency Virus (SHIV) hervor.

Wichtige Ergebnisse sind:

  • Die Studie zielte darauf ab zu bewerten, ob diese Kombination einen anhaltenden viralen Kontrollzustand ohne fortlaufende ART bieten kann
  • 18 Säugungsmakaken wurden mit verschiedenen Kombinationen von ART, bNAbs und Leronlimab behandelt
  • Bei den behandelten Tieren wurde über einen Zeitraum von 27 Wochen kein Virus-Rückfall beobachtet
  • Die Ergebnisse deuten auf das Potenzial für eine nachhaltige virale Kontrolle und einen verringerten Bedarf an fortlaufender ART hin

Die Studie, die durch einen NIH-Zuschuss an die OHSU finanziert wurde, wird von Dr. Jonah B. Sacha auf der Konferenz in Lima, Peru, am 10. Oktober 2024 vorgestellt werden.

Positive
  • Promising results showing no virus rebound in treated animals, suggesting potential for durable viral control
  • Potential for reducing or eliminating the need for lifelong daily HIV medication
  • Acceptance of abstract for presentation at a major HIV research conference
  • Study funded by NIH grant, indicating scientific interest and support
Negative
  • None.

Abstract to be presented at the 5th annual HIV Research for Prevention Conference

Study results highlight potential for treatment

VANCOUVER, Washington, Oct. 07, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced acceptance of an abstract for presentation at the 5th annual HIV Research for Prevention Conference. The abstract summarizes research on the potential of combining early antiretroviral therapy (ART) with a novel immunotherapy approach using broadly neutralizing antibodies (bNAbs) and leronlimab. This innovative treatment strategy was evaluated in infant rhesus macaques infected with Simian Human Immunodeficiency Virus (SHIV), offering promising insights into treatment possibilities to achieve viral control without the need for continuous ART.

Key Highlights of the Study:

  • Objective: To assess whether a combination of early ART initiation with bNAbs and leronlimab can provide sustained viral control in infant rhesus macaques, potentially reducing or eliminating the need for lifelong daily medication.
  • Methodology: Eighteen (18) infant rhesus macaques were infected with SHIV and then treated with various combinations of ART, bNAbs, and leronlimab. The study evaluated the efficacy of these treatments over a 27-week period, followed by a treatment interruption to monitor virus rebound.
  • Results: The combination of ART, bNAbs, and leronlimab showed promising results, with no virus rebound observed in any of the treated animals, suggesting a potential for durable viral control and a significant advancement towards minimizing or eliminating the need for ongoing ART.

“These results demonstrate a previously unappreciated synergy between CCR5 blockade and antibody neutralization that opens the door to a new approach for an HIV cure that should be explored further,” said Jonah B. Sacha, Ph.D, Chief of the Pathobiology and Immunology Division at the Oregon National Primate Research Center at Oregon Health & Science University. The study was funded by an NIH grant awarded to OHSU and led by Dr. Nancy Haigwood, Dr. Sacha, and their collaborators.

“We are proud to report these results as we continue to progress our clinical development pipelines for leronlimab across a number of clinical indications,” said Dr. Jay Lalezari, CEO of CytoDyn. “The potential for a treatment path for HIV utilizing leronlimab that allows for long-lasting viral control and potentially reduces or eliminates the need for ongoing ART is a thrilling prospect. We’re grateful to our partners at Oregon Health & Science University and look forward to continuing this important work.”

Dr. Sacha will present the abstract at the 5th annual HIV Research for Prevention Conference in Lima, Peru. Details on the presentation are shown below.

Title: Short-term combination immunotherapy with broadly neutralizing antibodies and CCR5 blockade mediates ART-free viral control in infant rhesus macaques
Presentation Type: Oral abstract session
Session Title: Planet of the Apes: Learning immunogenicity from animal models
Session Date and Time: October 10, 2024, 5:30-7:00PM PET

About CytoDyn

CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. Leronlimab is being studied for oncology and inflammation, as well as other potential indications, including but not limited to HIV and MASH.

Note Regarding Forward-Looking Statements
This news release contains forward-looking statements relating to, among other things, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements” and in Item 1A. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Media Contacts

CytoDyn
Riyaz Lalani
Gagnier Communications
CytoDyn@gagnierfc.com


FAQ

What is the main focus of CytoDyn's (CYDY) research presented in the abstract?

The research focuses on combining early antiretroviral therapy (ART) with broadly neutralizing antibodies (bNAbs) and leronlimab to achieve sustained viral control in infant rhesus macaques infected with SHIV, potentially reducing or eliminating the need for lifelong daily HIV medication.

When and where will CytoDyn's (CYDY) research be presented?

The research will be presented at the 5th annual HIV Research for Prevention Conference in Lima, Peru on October 10, 2024.

What were the key results of CytoDyn's (CYDY) study on leronlimab?

The study showed no virus rebound in treated animals over a 27-week period, suggesting potential for durable viral control and a significant advancement towards minimizing or eliminating the need for ongoing ART in HIV treatment.

Who funded the study on leronlimab conducted by CytoDyn (CYDY)?

The study was funded by an NIH grant awarded to Oregon Health & Science University (OHSU).

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