SIGA Enters into Exclusive License Agreement with Vanderbilt University for Novel Poxvirus Monoclonal Antibodies
SIGA Technologies (NASDAQ: SIGA) has entered into an exclusive license agreement with Vanderbilt University for a portfolio of preclinical fully human monoclonal antibodies (mAbs). These mAbs have potential as treatments for a broad range of orthopoxviruses, including smallpox and mpox. The agreement grants SIGA exclusive rights to develop, manufacture, and commercialize these mAbs globally.
The mAbs, developed by Dr. James Crowe at Vanderbilt University Medical Center, have shown promise in preclinical models and could be used as standalone treatments or in combination with SIGA's TPOXX® franchise. The U.S. Department of Defense is currently funding the development of these mAbs through Phase 1 clinical trials. SIGA aims to leverage its expertise in orthopoxvirus and partnerships with U.S. Government agencies to maximize the impact of these potential new therapies.
SIGA Technologies (NASDAQ: SIGA) ha stipulato un accordo di licenza esclusivo con Vanderbilt University per un portfolio di anticorpi monoclonali completamente umani (mAbs) ancora in fase preclinica. Questi mAbs hanno un potenziale come trattamenti per una vasta gamma di orthopoxvirus, inclusi il vaiolo e l'mpox. L'accordo concede a SIGA diritti esclusivi per sviluppare, produrre e commercializzare questi mAbs a livello globale.
Gli mAbs, sviluppati dal Dott. James Crowe presso il Vanderbilt University Medical Center, hanno mostrato promettenti risultati in modelli preclinici e potrebbero essere utilizzati come trattamenti autonomi o in combinazione con il franchise TPOXX® di SIGA. Attualmente, il Dipartimento della Difesa degli Stati Uniti sta finanziando lo sviluppo di questi mAbs attraverso studi clinici di Fase 1. SIGA mira a sfruttare la propria esperienza negli orthopoxvirus e le collaborazioni con le agenzie governative statunitensi per massimizzare l'impatto di queste potenziali nuove terapie.
SIGA Technologies (NASDAQ: SIGA) ha firmado un acuerdo de licencia exclusivo con Vanderbilt University para un portafolio de anticuerpos monoclonales completamente humanos (mAbs) en fase preclínica. Estos mAbs tienen potencial como tratamientos para una amplia gama de orthopoxvirus, incluidos la viruela y el mpox. El acuerdo otorga a SIGA derechos exclusivos para desarrollar, fabricar y comercializar estos mAbs a nivel global.
Los mAbs, desarrollados por el Dr. James Crowe en el Vanderbilt University Medical Center, han mostrado promesas en modelos preclínicos y podrían ser utilizados como tratamientos independientes o en combinación con la franquicia TPOXX® de SIGA. Actualmente, el Departamento de Defensa de EE. UU. está financiando el desarrollo de estos mAbs a través de ensayos clínicos en Fase 1. SIGA pretende aprovechar su experiencia en orthopoxvirus y asociaciones con agencias gubernamentales de EE. UU. para maximizar el impacto de estas potenciales nuevas terapias.
SIGA Technologies (NASDAQ: SIGA)는 밴더빌트 대학교와 독점 라이센스 계약을 체결하여 완전 인간 단클론 항체(mAbs)의 전임상 포트폴리오를 확보하였습니다. 이러한 mAbs는 천연두 및 mpox를 포함한 다양한 orthopoxvirus의 치료제로서 잠재력을 가지고 있습니다. 이 계약은 SIGA에게 이러한 mAbs를 글로벌 차원에서 개발, 제조 및 상업화할 수 있는 독점 권리를 부여합니다.
mAbs는 밴더빌트 대학교 의대의 제임스 크로우 박사에 의해 개발되었으며, 전임상 모델에서 유망한 성과를 보였고, SIGA의 TPOXX® 프랜차이즈와 함께 또는 독립적인 치료제로 사용될 수 있습니다. 현재 미국 국방부는 이러한 mAbs의 개발을 1상 임상 시험을 통해 지원하고 있습니다. SIGA는 orthopoxvirus에 대한 전문성과 미국 정부 기관과의 파트너십을 활용하여 이러한 잠재적인 새로운 치료법의 영향을 극대화하는 것을 목표로 하고 있습니다.
SIGA Technologies (NASDAQ: SIGA) a conclu un accord de licence exclusif avec Vanderbilt University pour un portefeuille d'anticorps monoclonaux entièrement humains (mAbs) en phase préclinique. Ces mAbs ont un potentiel en tant que traitements pour une large gamme d'orthopoxvirus, y compris la variole et le mpox. L'accord accorde à SIGA des droits exclusifs pour développer, fabriquer et commercialiser ces mAbs à l'échelle mondiale.
Les mAbs, développés par le Dr James Crowe au Vanderbilt University Medical Center, ont montré des promesses dans des modèles précliniques et pourraient être utilisés comme traitements autonomes ou en combinaison avec la franchise TPOXX® de SIGA. Le Département de la Défense des États-Unis finance actuellement le développement de ces mAbs par le biais des essais cliniques de Phase 1. SIGA vise à tirer parti de son expertise en orthopoxvirus et de ses partenariats avec les agences gouvernementales américaines pour maximiser l'impact de ces nouvelles thérapies potentielles.
SIGA Technologies (NASDAQ: SIGA) hat einen exklusiven Lizenzvertrag mit Vanderbilt University für ein Portfolio von vollständig menschlichen monoklonalen Antikörpern (mAbs) im präklinischen Stadium abgeschlossen. Diese mAbs haben Potenzial als Behandlungen für eine Vielzahl von Orthopoxviren, einschließlich Pocken und mpox. Der Vertrag gewährt SIGA exklusive Rechte zur Entwicklung, Herstellung und Vermarktung dieser mAbs weltweit.
Die mAbs, die von Dr. James Crowe am Vanderbilt University Medical Center entwickelt wurden, haben in präklinischen Modellen vielversprechende Ergebnisse gezeigt und könnten als eigenständige Behandlungen oder in Kombination mit SIGAs TPOXX®-Franchise eingesetzt werden. Das US-Verteidigungsministerium finanziert derzeit die Entwicklung dieser mAbs durch klinische Phase-1-Studien. SIGA beabsichtigt, seine Expertise in Orthopoxviren und die Partnerschaften mit US-Regierungsbehörden zu nutzen, um die Auswirkungen dieser potenziellen neuen Therapien zu maximieren.
- Exclusive global rights obtained for promising orthopoxvirus treatment mAbs
- Potential for standalone or combination therapy with existing TPOXX® franchise
- U.S. Department of Defense funding development through Phase 1 clinical trials
- Expands SIGA's pipeline and leverages existing expertise in orthopoxviruses
- None.
Insights
This exclusive license agreement with Vanderbilt University is a strategic move for SIGA, expanding its pipeline in the orthopoxvirus space. The acquisition of rights to develop monoclonal antibodies (mAbs) complements SIGA's existing TPOXX® franchise, potentially broadening its market reach.
Key points to consider:
- The mAbs show promise for both therapeutic and prophylactic use against various orthopoxviruses, including smallpox and mpox.
- Development is currently funded by the U.S. Department of Defense through Phase 1 trials, indicating government interest and potential future contracts.
- The ability to use these mAbs as standalone treatments or in combination with TPOXX® could enhance SIGA's product offerings.
While this agreement represents a long-term growth opportunity, investors should note that the mAbs are still in preclinical stages. The path to commercialization will require significant time and investment, with no guarantee of success. However, SIGA's expertise in orthopoxviruses and established government relationships could accelerate development and potential market entry.
From a financial perspective, this licensing agreement presents both opportunities and risks for SIGA:
- Potential for revenue diversification and expansion of SIGA's product portfolio in the long term.
- Leveraging existing infrastructure and partnerships could lead to cost efficiencies in development.
- Government funding for initial development phases reduces immediate financial burden on SIGA.
However, investors should consider:
- Undisclosed financial terms make it difficult to assess the immediate impact on SIGA's balance sheet.
- Future development costs beyond Phase 1 trials may be substantial.
- Time to market and potential returns are uncertain, given the early stage of development.
With a market cap of
NEW YORK, Oct. 22, 2024 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company and leader in infectious diseases, today announced that it entered into an agreement with Vanderbilt University to obtain a license to a portfolio of preclinical fully human monoclonal antibodies (mAbs) which could be used as potential treatments for a broad range of orthopoxviruses, including smallpox and mpox. Under the agreement, SIGA has exercised its option to license the exclusive rights to develop, manufacture, and commercialize these mAbs globally.
“SIGA has cultivated deep expertise in orthopoxvirus, and we are thrilled to expand our pipeline with Vanderbilt’s human monoclonal antibodies, which nicely complement our best-in-class TPOXX® franchise. We believe these antibodies hold the potential to treat a broad spectrum of orthopoxviruses, both as a therapeutic and a prophylactic measure. By leveraging our unique capabilities in clinical development and our long-standing partnerships with U.S. Government agencies, we are well-positioned to maximize the impact of these potential new therapies,” said Diem Nguyen, SIGA Chief Executive Officer. “This license marks a step forward in our strategy to leverage our existing capabilities to create new opportunities for growth over the long term.”
Developed by James Crowe, Jr., M.D., Professor of Pediatrics, Pathology, Microbiology and Immunology at Vanderbilt University Medical Center, these mABs have demonstrated promise in preclinical models and could potentially be used as standalone treatments or in combination with TPOXX®. The U.S. Department of Defense is currently funding the development of these mAbs as potential orthopoxvirus treatments through Phase 1 clinical trials under a contract awarded to a contract manufacturing organization with biologics expertise.
“Given the need for additional orthopoxvirus treatments in these unsettling times of recurring poxvirus outbreaks, my team and I are excited to work with SIGA in its future efforts to advance the development of these innovative antibodies,” said Dr. Crowe.
The financial terms of the transaction were not disclosed.
About SIGA
SIGA is a commercial-stage pharmaceutical company and leader in global health focused on the development of innovative medicines to treat and prevent infectious diseases. With a primary focus on orthopoxviruses, we are dedicated to protecting humanity against the world’s most severe infectious diseases, including those that occur naturally, accidentally, or intentionally. Through partnerships with governments and public health agencies, we work to build a healthier and safer world by providing essential countermeasures against these global health threats. Our flagship product, TPOXX® (tecovirimat), is an antiviral medicine approved in the U.S. and Canada for the treatment of smallpox and authorized in Europe and the UK for the treatment of smallpox, mpox (monkeypox), cowpox, and vaccinia complications. For more information about SIGA, visit www.siga.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to SIGA’s future business development and plans including with respect to filling outstanding orders. The words or phrases “can be,” “expects,” “may affect,” “may depend,” “believes,” “estimate,” “will”, “project” and similar words and phrases are intended to identify such forward-looking statements. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the 75A50118C00019 BARDA Contract (the “BARDA Contract”), not to exercise the remaining unexercised option under the BARDA Contract, (ii) the risk that SIGA may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contract or U.S. Department of Defense contracts are modified or canceled at the request or requirement of, or SIGA is not able to enter into new contracts to supply TPOXX to, the U.S. Government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that target timing for deliveries of product to customers, and the recognition of related revenues, are delayed or adversely impacted by the actions, or inaction, of contract manufacturing organizations, or other vendors, within the supply chain, or due to coordination activities between the customer and supply chain vendors, (vii) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market TPOXX for smallpox or additional uses, (viii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (ix) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (x) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed approvals to market these products, (xi) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xii) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xiii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (xiv) the risk of disruptions to SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government contracts, or diverting the attention of government staff overseeing SIGA’s government contracts, (xv) risks associated with actions or uncertainties surrounding the debt ceiling, (xvi) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases, are ineffective and may adversely affect SIGA’s business, and (xvii) risks associated with responding to an mpox outbreak, as well as the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2023 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at http://www.sec.gov. All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.
Contacts:
Suzanne Harnett
sharnett@siga.com
and
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FAQ
What is the purpose of SIGA's new license agreement with Vanderbilt University?
How might SIGA (NASDAQ: SIGA) benefit from this new license agreement?
Who is funding the development of the licensed monoclonal antibodies for SIGA?
What potential applications do the licensed mAbs have for SIGA's orthopoxvirus treatments?
