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Teva and Biolojic Design Initiate IND-enabling Studies of BD9, a Multibody Designed to Explore the Treatment of Atopic Dermatitis and Asthma

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Teva Pharmaceutical and Biolojic Design have initiated IND-enabling studies for BD9, a novel dual-specific multibody targeting both TSLP and IL-13 for treating atopic dermatitis and asthma. BD9 was developed using Biolojic's Multibody Platform, which creates antibodies capable of addressing multiple disease targets simultaneously. The therapy aims to improve outcomes for patients with TH2-driven inflammatory diseases where current treatments are inadequate. This development aligns with Teva's Pivot to Growth strategy to enhance innovation in their pipeline. Under the agreement, Teva holds worldwide development rights for BD9, while Biolojic is eligible for milestone payments based on pre-clinical, clinical, regulatory, and commercial achievements.
Teva Pharmaceutical e Biolojic Design hanno avviato studi per l'abilitazione IND su BD9, un nuovo multibody dual-specifico che mira sia a TSLP sia a IL-13 per il trattamento della dermatite atopica e dell'asma. BD9 è stato sviluppato utilizzando la Multibody Platform di Biolojic, che crea anticorpi in grado di affrontare simultaneamente più bersagli patologici. La terapia punta a migliorare i risultati per i pazienti con malattie infiammatorie guidate da TH2, dove i trattamenti attuali risultano insufficienti. Questo sviluppo è in linea con la strategia Pivot to Growth di Teva per potenziare l'innovazione nel loro portafoglio. Secondo l'accordo, Teva detiene i diritti mondiali per lo sviluppo di BD9, mentre Biolojic può ricevere pagamenti legati al raggiungimento di milestone precliniche, cliniche, regolatorie e commerciali.
Teva Pharmaceutical y Biolojic Design han iniciado estudios para la habilitación IND de BD9, un novedoso multibody dual-específico que apunta tanto a TSLP como a IL-13 para el tratamiento de la dermatitis atópica y el asma. BD9 fue desarrollado utilizando la Plataforma Multibody de Biolojic, que crea anticuerpos capaces de abordar múltiples objetivos de enfermedad simultáneamente. La terapia busca mejorar los resultados en pacientes con enfermedades inflamatorias impulsadas por TH2, donde los tratamientos actuales son insuficientes. Este desarrollo está alineado con la estrategia Pivot to Growth de Teva para potenciar la innovación en su pipeline. Según el acuerdo, Teva posee los derechos mundiales de desarrollo de BD9, mientras que Biolojic es elegible para pagos por hitos basados en logros preclínicos, clínicos, regulatorios y comerciales.
테바 제약과 바이올로직 디자인은 BD9에 대한 IND 승인 연구를 시작했습니다. BD9는 TSLP와 IL-13을 동시에 표적하는 새로운 이중 특이성 멀티바디로, 아토피 피부염과 천식 치료를 위해 개발되었습니다. BD9는 바이올로직의 멀티바디 플랫폼을 활용해 여러 질병 표적을 동시에 겨냥하는 항체를 만들어 냈습니다. 이 치료법은 기존 치료법이 부족한 TH2 매개 염증성 질환 환자의 치료 효과를 개선하는 것을 목표로 합니다. 이 개발은 테바의 Pivot to Growth 전략과 부합하여 파이프라인 내 혁신을 강화합니다. 계약에 따라 테바는 BD9의 전 세계 개발 권리를 보유하며, 바이올로직은 전임상, 임상, 규제 및 상업적 성과에 따른 마일스톤 지급 자격이 있습니다.
Teva Pharmaceutical et Biolojic Design ont lancé des études d'habilitation IND pour BD9, un nouveau multibody dual-spécifique ciblant à la fois TSLP et IL-13 pour le traitement de la dermatite atopique et de l'asthme. BD9 a été développé grâce à la plateforme Multibody de Biolojic, qui crée des anticorps capables de cibler plusieurs pathologies simultanément. Cette thérapie vise à améliorer les résultats chez les patients souffrant de maladies inflammatoires à médiation TH2, pour lesquelles les traitements actuels sont insuffisants. Ce développement s'inscrit dans la stratégie Pivot to Growth de Teva visant à renforcer l'innovation dans leur portefeuille. Selon l'accord, Teva détient les droits mondiaux de développement de BD9, tandis que Biolojic est éligible à des paiements liés à des jalons précliniques, cliniques, réglementaires et commerciaux.
Teva Pharmaceutical und Biolojic Design haben IND-freigabe Studien für BD9 eingeleitet, ein neuartiges dual-spezifisches Multibody, das sowohl TSLP als auch IL-13 für die Behandlung von atopischer Dermatitis und Asthma anvisiert. BD9 wurde mithilfe der Multibody-Plattform von Biolojic entwickelt, die Antikörper erzeugt, die mehrere Krankheitsziele gleichzeitig adressieren können. Die Therapie zielt darauf ab, die Behandlungsergebnisse für Patienten mit TH2-gesteuerten Entzündungserkrankungen zu verbessern, bei denen aktuelle Therapien unzureichend sind. Diese Entwicklung steht im Einklang mit Tevas Pivot to Growth-Strategie, um Innovationen im Portfolio zu fördern. Gemäß der Vereinbarung hält Teva die weltweiten Entwicklungsrechte für BD9, während Biolojic für Meilensteinzahlungen basierend auf präklinischen, klinischen, regulatorischen und kommerziellen Erfolgen berechtigt ist.
Positive
  • Advancement to IND-enabling studies represents a significant milestone in drug development
  • BD9's dual-targeting mechanism could potentially offer better efficacy than existing treatments
  • Worldwide development rights secured by Teva for BD9
  • Therapy addresses large markets (atopic dermatitis and asthma) with unmet medical needs
Negative
  • Early-stage development with significant clinical trials still ahead
  • Milestone payment obligations to Biolojic could impact profitability
  • No guarantee of successful transition from pre-clinical to clinical trials

Insights

Teva advances novel dual-target antibody BD9 to IND-enabling studies, strengthening its immunology pipeline with potential advantages over single-target treatments.

Teva has reached a significant milestone with BD9, initiating IND-enabling studies for this innovative dual-targeting antibody therapy. BD9 represents a potentially superior approach to treating TH2-driven inflammatory conditions by simultaneously inhibiting two critical disease drivers - TSLP and IL-13.

What makes this development scientifically noteworthy is the multibody platform technology from Biolojic Design, which enables a single antibody to engage multiple targets with high specificity. Traditional therapies typically block only one inflammatory pathway, often leading to suboptimal efficacy as alternative pathways remain active. By targeting both TSLP (an upstream alarm signal that initiates allergic inflammation) and IL-13 (a downstream effector cytokine), BD9 could potentially provide more comprehensive pathway inhibition.

This milestone positions Teva to potentially enter clinical trials within 12-18 months, assuming favorable toxicology and safety data. For context, the addressable market is substantial - atopic dermatitis affects approximately 16.5 million adults in the US alone, while asthma impacts over 25 million Americans. Current biologics for these conditions (like dupilumab) generate billions in annual revenue, highlighting the commercial opportunity.

The progression of BD9 demonstrates Teva's strategic pivot toward innovative biologics beyond their traditional generics business. While this program remains years from potential commercialization, it represents a valuable pipeline asset with milestone-based economics for both companies, indicating thoughtful risk management in the development partnership.

  • BD9 is a multibody that targets IL-13 and TSLP, and has potential to treat TH-2-driven inflammatory diseases

  • BD9 designed using Biolojic’s Multibody Platform, which generates Antibodies capable of addressing multiple disease targets

  • Collaboration builds on Teva’s Pivot to Growth strategy to step up innovation in Teva’s innovative pipeline

REHOVOT, Israel and WASHINGTON and TEL AVIV, Israel, May 27, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) and Biolojic Design Ltd. (“Biolojic”), a biotechnology company using computational biology and artificial intelligence to design next generation, multifunctional antibodies known as multibodies, announced today that Teva initiated IND-enabling studies with BD9, a dual-specific multibody targeting both TSLP (Thymic stromal lymphopoietin) and IL-13. Teva has an exclusive license to develop BD9 for the treatment of TH2-driven inflammatory diseases such as atopic dermatitis and asthma. 

Teva’s development of BD9 demonstrates the company’s commitment to applying cutting-edge science to address unmet medical needs. By simultaneously blocking two key drivers of TH2-driven inflammation, BD9 has the potential to improve outcomes for patients with conditions such as atopic dermatitis and asthma, where current treatments fall short. The initiation of IND-enabling studies marks a critical milestone in translating this scientific innovation into a potential therapeutic option, paving the way for clinical trials and ultimately bringing hope to underserved patient populations. This progress exemplifies Teva’s focus on advancing transformative therapies that expand access and impact through innovation.

“We’re excited to have successfully achieved another milestone in our partnership with Teva,” said Yanay Ofran, PhD, CEO and founder of Biolojic Design. “Biolojic’s next generation antibody platform has now produced four antibodies that are in, or nearing, the clinic. From the clinical data we have recently seen, it is already clear that our precision antibodies have distinct advantages over traditional antibodies, extracting better efficacy and safety from complex biological targets.”

Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva said, “With the initiation of IND-enabling studies we take a vital step toward delivering innovative treatments to patients who need them most. This pre-clinical progress underscores Teva’s commitment to accelerating innovation and to improving health outcomes and access to underserved patient populations.”

Under the terms of their agreement, Teva is developing BD9 worldwide. In exchange, Biolojic is eligible to receive milestone payments based on the achievement of certain pre-clinical, clinical, regulatory, and commercial milestones, including the initiation of IND-enabling studies.

About Biolojic Design
Biolojic Design is pioneering the use of precision antibodies, including multibodies, a next generation antibody technology in which each arm of a conventional IgG (immunoglobulin G) antibody can bind to multiple targets, enabling a multibody to address complex disease biology. Biolojic designs its multibodies using computational biology and AI, and its platform generated the first AI-designed antibody to enter the clinic, which is now in phase 2 clinical trials. The company’s pipeline focuses on autoimmune diseases and oncology, unlocking validated pathways that address large unmet needs. It is progressing its own pipeline, and has partnerships with several leading biopharmaceutical companies to enhance its ability to bring important new medicines to patients. For more information about Biolojic Design and its science and pipeline, please visit https://biolojic.com/ or follow us on LinkedIn.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients’ needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit www.tevapharm.com.

Teva Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our partnership with Biolojic; our ability to successfully develop BD9, a Dual-Specific Antibody Designed to Explore the Treatment of TH2-driven inflammatory diseases; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines; and to execute on our organizational transformation and to achieve expected cost savings and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors” and “Forward-Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Teva Media InquiriesTevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations InquiriesTevaIR@Tevapharm.com

FAQ

What is BD9 and what conditions does it target?

BD9 is a dual-specific multibody that targets both TSLP and IL-13, designed to treat TH2-driven inflammatory diseases such as atopic dermatitis and asthma.

What stage of development is TEVA's BD9 currently in?

BD9 has entered IND-enabling studies, which is a pre-clinical stage preparing for potential future clinical trials.

What is the partnership structure between Teva and Biolojic for BD9?

Teva has exclusive worldwide development rights for BD9, while Biolojic is eligible to receive milestone payments based on pre-clinical, clinical, regulatory, and commercial achievements.

How does BD9 differ from traditional treatments for atopic dermatitis and asthma?

BD9 is unique in simultaneously blocking two key drivers of TH2-driven inflammation (TSLP and IL-13), potentially offering improved outcomes compared to current treatments.

What is the significance of IND-enabling studies for TEVA's BD9 development?

IND-enabling studies are a crucial milestone that prepares for the submission of an Investigational New Drug application, necessary before beginning clinical trials in humans.
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