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ModeX Therapeutics Secures $35 Million BARDA Supplement to Develop COVID Multispecific Antibodies and $16 Million to Initiate Influenza Program

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ModeX Therapeutics, an OPKO Health company, has secured $51 million in additional funding from BARDA. This includes $35 million for developing a second novel multispecific antibody to SARS-CoV-2 and $16 million to initiate an influenza program. The total BARDA funding now reaches $110 million, with potential for up to $205 million if all options are executed.

The funding will support the development of ModeX's proprietary MSTAR platform, which incorporates multiple antibody binding sites into a single molecule. This technology aims to provide broader protection against viral threats and potentially benefit immune-suppressed patients. The project includes exploring gene-based expression of multispecific antibodies, which could reduce manufacturing costs and allow faster responses to emerging threats.

ModeX Therapeutics, un'azienda di OPKO Health, ha ottenuto 51 milioni di dollari in finanziamenti aggiuntivi da BARDA. Questo include 35 milioni di dollari per lo sviluppo di un secondo anticorpo multispecifico innovativo per SARS-CoV-2 e 16 milioni di dollari per avviare un programma sull'influenza. Il finanziamento totale da BARDA ora raggiunge 110 milioni di dollari, con la possibilità di arrivare fino a 205 milioni di dollari se tutte le opzioni vengono eseguite.

Il finanziamento supporterà lo sviluppo della piattaforma proprietaria di ModeX, MSTAR, che incorpora più siti di legame per gli anticorpi in una singola molecola. Questa tecnologia mira a fornire una protezione più ampia contro le minacce virali e potrebbe beneficiare i pazienti immunocompromessi. Il progetto include l'esplorazione dell'espressione genica di anticorpi multispecifici, il che potrebbe ridurre i costi di produzione e consentire risposte più rapide alle minacce emergenti.

ModeX Therapeutics, una empresa de OPKO Health, ha asegurado 51 millones de dólares en financiamiento adicional de BARDA. Esto incluye 35 millones de dólares para desarrollar un segundo anticuerpo multispecífico novedoso para SARS-CoV-2 y 16 millones de dólares para iniciar un programa de influenza. El financiamiento total de BARDA ahora alcanza 110 millones de dólares, con un potencial de hasta 205 millones de dólares si se ejecutan todas las opciones.

El financiamiento apoyará el desarrollo de la plataforma propietaria de ModeX, MSTAR, que incorpora múltiples sitios de unión de anticuerpos en una sola molécula. Esta tecnología tiene como objetivo proporcionar una protección más amplia contra amenazas virales y potencialmente beneficiar a pacientes inmunodeprimidos. El proyecto incluye la exploración de la expresión génica de anticuerpos multispecíficos, lo que podría reducir los costos de fabricación y permitir respuestas más rápidas a las amenazas emergentes.

ModeX Therapeutics는 OPKO Health의 자회사로서 BARDA로부터 5,100만 달러의 추가 자금을 확보했습니다. 여기에는 SARS-CoV-2에 대한 두 번째 신규 다중 특이성 항체 개발을 위한 3,500만 달러와 인플루엔자 프로그램을 시작하는 데 필요한 1,600만 달러가 포함됩니다. 총 BARDA 자금은 이제 1억 1천만 달러에 도달하며, 모든 옵션이 실행될 경우 최대 2억 5천만 달러에 이를 수 있습니다.

이 자금은 여러 항체 결합 부위를 단일 분자에 통합한 ModeX의 독자적인 MSTAR 플랫폼 개발을 지원할 것입니다. 이 기술은 바이러스 위협에 대한 더 넓은 보호를 제공하고 면역 억제 환자에게 잠재적으로 도움이 되는 것을 목표로 합니다. 이 프로젝트에는 다중 특이성 항체의 유전자 기반 발현 탐색이 포함되며, 이는 제조 비용을 줄이고 새로운 위협에 대한 더 빠른 대응을 가능하게 할 수 있습니다.

ModeX Therapeutics, une entreprise d'OPKO Health, a sécurisé 51 millions de dollars de financement supplémentaire de la part de BARDA. Cela comprend 35 millions de dollars pour développer un deuxième anticorps multispecifique novateur contre le SARS-CoV-2 et 16 millions de dollars pour initier un programme sur la grippe. Le financement total de BARDA atteint désormais 110 millions de dollars, avec un potentiel allant jusqu'à 205 millions de dollars si toutes les options sont exécutées.

Ce financement soutiendra le développement de la plateforme propriétaire de ModeX, MSTAR, qui intègre plusieurs sites de liaison d'anticorps dans une seule molécule. Cette technologie vise à offrir une protection plus large contre les menaces virales et pourrait potentiellement bénéficier aux patients immunodéprimés. Le projet inclut l'exploration de l'expression génique d'anticorps multispecifiques, ce qui pourrait réduire les coûts de fabrication et permettre des réponses plus rapides face aux menaces émergentes.

ModeX Therapeutics, ein Unternehmen von OPKO Health, hat von BARDA 51 Millionen Dollar an zusätzlicher Finanzierung gesichert. Dies umfasst 35 Millionen Dollar für die Entwicklung eines zweiten neuartigen multispezifischen Antikörpers gegen SARS-CoV-2 und 16 Millionen Dollar, um ein Influenza-Programm zu initiieren. Die gesamte BARDA-Finanzierung erreicht nun 110 Millionen Dollar, mit dem Potenzial, auf bis zu 205 Millionen Dollar zu steigen, wenn alle Optionen ausgeführt werden.

Die Finanzierung wird die Entwicklung der proprietären MSTAR-Plattform von ModeX unterstützen, die mehrere Antikörperbindungsstellen in ein einzelnes Molekül integriert. Diese Technologie zielt darauf ab, einen breiteren Schutz gegen virale Bedrohungen zu bieten und potenziell immungeschwächte Patienten zu unterstützen. Das Projekt umfasst die Erforschung der genbasierten Expression von multispezifischen Antikörpern, was die Produktionskosten senken und schnellere Reaktionen auf neue Bedrohungen ermöglichen könnte.

Positive
  • Secured $51 million in additional BARDA funding
  • Total BARDA funding increased to $110 million, with potential for up to $205 million
  • Developing novel multispecific antibodies for SARS-CoV-2 and influenza
  • MSTAR platform offers potential for broader protection against viral threats
  • Exploring gene-based antibody expression for potentially reduced manufacturing costs
Negative
  • None.
  • Brings total awards from BARDA to $110 million for development of broad SARS-CoV-2 and Influenza multispecifics, with potential funding of up to $205 million if all options are executed
  • Development work is based on ModeX proprietary MSTAR technology that incorporates multiple antibody binding sites into a single molecule

WESTON, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health, Inc. (NASDAQ: OPK) company, announces it has been awarded $35 million of additional funding under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services (HHS).

This funding will support the development of a second novel multispecific antibody to SARS-CoV-2 from preclinical through Phase 1 trials, as well as preclinical work on gene-based expression of multispecific antibodies to SARS-CoV-2 including mRNA and/or DNA vectors. In addition, ModeX will begin development of influenza multispecifics with gene and/or protein delivery modalities by initiating the second phase of BARDA funding through activation of a $16 million option.

The funding and advancement of these programs will further explore ModeX’s proprietary MSTAR platform to prepare for outbreaks and respond rapidly to emerging viral threats. Together, this funding brings the total support awarded to ModeX to $110 million out of $205 million if all options are executed.

“A rapid response with broadly protective antibodies is crucial to effectively contain outbreaks of viruses like influenza or SARS-CoV-2. By design, our multispecific platform represents a potential countermeasure that could swiftly provide coverage against such public health threats,” said Dr. Gary Nabel, President and Chief Executive Officer of ModeX.

MSTAR is a flexible multivalent, multispecific antibody design platform that allows the incorporation of multiple independent antibody binding sites into a single molecule, thus expanding their therapeutic potential while enabling rapid responses to emerging and re-emerging viral pathogens, including SARS-CoV-2 and influenza. These antibodies also have the potential to confer protection in immune-suppressed, cancer and other patients with suboptimal responses to vaccination.

Despite the seasonal availability of vaccines, influenza-related disease and COVID remain significant public health issues. Multispecific antibodies have the potential for wider breadth of coverage to enable protection against multiple strains of a pathogen and be more resilient against pathogen evolution. Gene-based antibody expression represents a new method with potential to significantly reduce manufacturing costs and allow faster pivoting for new and emerging threats compared with conventional protein-based antibodies.

“Through our collaboration with BARDA, we are working to develop new medicines to protect the public from existing and emerging infectious disease pathogens,” added Dr. Elias Zerhouni, President of OPKO. “We are pleased with additional funding from BARDA. Cutting-edge technologies like those from ModeX have the potential to address pressing public health needs.”

The contract was originally awarded to ModeX in September of 2023, and it is supported through Project Next Gen efforts, which support development of next-generation COVID-19 vaccines and therapeutics, and through BARDA’s Flexible and Strategic Therapeutics (FASTx) program, which aims to transform antiviral therapy by developing rapidly adaptable platforms to combat viral threats.

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00056.

About ModeX Therapeutics

ModeX Therapeutics is a clinical-stage biopharmaceutical company developing innovative multispecific biologics for cancer and infectious disease. Its platforms unite the power of multiple biologics in a single molecule to create multispecific antibodies and vaccines with unprecedented versatility and potency in fighting complex disease. The ModeX pipeline includes candidates against both solid and hematologic tumors, as well as several of the world’s most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is an OPKO Health company based in Weston, Massachusetts. For more information, please visit www.modextx.com.

About OPKO Health, Inc.

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and novel and proprietary technologies. For more information, visit www.opko.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," “could,” "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. These statements concern, and these risks and uncertainties include, among others, product candidates being developed by ModeX and/or its collaborators or licensees and research and clinical programs now underway or planned, including without limitation ModeX’s MSTAR technology, and its next-generation MSTAR multispecific antibody therapy intending to target known variants of SARS-CoV-2, as discussed in this press release; the feasibility and success of the MSTAR platform; whether additional funding of up to $93 million will be granted to ModeX even if it were to achieve the specified milestones, the extent to which the results from the research and development programs conducted by ModeX and/or its collaborators may lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of ModeX’s product candidates and the impact of studies (whether conducted by ModeX or others) on any of the foregoing or any potential regulatory approval of ModeX’s product candidates; safety issues resulting from the administration of ModeX’s product candidates in patients; determinations by regulatory and administrative governmental authorities which may delay or restrict ModeX’s ability to continue to develop or commercialize its product candidates; competing drugs and product candidates that may be superior to, or more cost effective than, ModeX’s product candidates; the costs of developing products and any supply chain concerns; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on ModeX’s business; the health need for ModeX’s product candidates; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, as well as other non-historical statements, including statements about our expectations, products, beliefs or intentions regarding ModeX, projected future clinical developments, the potential for ModeX products and pipeline and any other statements regarding OPKO’s and ModeX’s future expectations, beliefs, plans, product candidates, objectives, financial conditions, assumptions or future events or performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, the success of our relationship with our commercial partners, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, and that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Investors:

LHA Investor Relations
Yvonne Briggs, 310-691-7100
ybriggs@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com

Media:
ModeX Media Relations
media@modextx.com


FAQ

What is the total BARDA funding received by ModeX Therapeutics (OPK) for COVID and influenza research?

ModeX Therapeutics, an OPKO Health (OPK) company, has received a total of $110 million in BARDA funding for COVID and influenza research, with potential for up to $205 million if all options are executed.

How much additional funding did ModeX Therapeutics (OPK) secure for SARS-CoV-2 antibody development?

ModeX Therapeutics (OPK) secured an additional $35 million from BARDA for the development of a second novel multispecific antibody to SARS-CoV-2, from preclinical through Phase 1 trials.

What is the MSTAR platform developed by ModeX Therapeutics (OPK)?

The MSTAR platform is ModeX Therapeutics' (OPK) proprietary technology that incorporates multiple antibody binding sites into a single molecule, aiming to provide broader protection against viral threats and potentially benefit immune-suppressed patients.

How much funding did ModeX Therapeutics (OPK) receive to initiate its influenza program?

ModeX Therapeutics (OPK) received $16 million from BARDA to initiate the development of influenza multispecifics with gene and/or protein delivery modalities.

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