Certara & Ichnos Glenmark Innovation Collaboration Optimizes Dosing Strategy for Potential First-In-Class Cancer Drug
Certara (Nasdaq: CERT) and Ichnos Glenmark Innovation (IGI) collaborated on optimizing the first-in-human dosing strategy for ISB 2001, a trispecific T-cell engager for cancer treatment. The research, published in Nature Cancer, used virtual trials to select a higher starting dose, increasing it by 50-100 fold over conventional methods. This approach, approved by the FDA and Australian HREC, aims to reduce costs, minimize ineffective dosing, and accelerate drug development.
The collaboration leveraged Certara's expertise in quantitative systems pharmacology and physiologically-based pharmacokinetics to develop a virtual clinical trial platform. This innovative method not only enhances patient safety and efficacy but also aligns with regulatory goals to reduce animal studies. The optimized dosing strategy for ISB 2001 showcases the potential of virtual patient technology in drug development, particularly for complex biologics like T-cell engagers.
Certara (Nasdaq: CERT) e Ichnos Glenmark Innovation (IGI) hanno collaborato per ottimizzare la strategia di dosaggio per ISB 2001, un engager delle cellule T trispecifiche per il trattamento del cancro. La ricerca, pubblicata su Nature Cancer, ha utilizzato prove virtuali per selezionare una dose iniziale più alta, aumentandola da 50 a 100 volte rispetto ai metodi convenzionali. Questo approccio, approvato dalla FDA e dall'HREC australiano, mira a ridurre i costi, minimizzare dosaggi inefficaci e accelerare lo sviluppo dei farmaci.
La collaborazione ha sfruttato l'expertise di Certara in farmacologia dei sistemi quantitativi e farmacocinetica basata sulla fisiologia per sviluppare una piattaforma di sperimentazione clinica virtuale. Questo metodo innovativo non solo migliora la sicurezza e l'efficacia per i pazienti, ma si allinea anche con gli obiettivi normativi per ridurre gli studi sugli animali. La strategia di dosaggio ottimizzata per ISB 2001 dimostra il potenziale della tecnologia dei pazienti virtuali nello sviluppo di farmaci, in particolare per biologici complessi come gli engager delle cellule T.
Certara (Nasdaq: CERT) e Ichnos Glenmark Innovation (IGI) colaboraron en la optimización de la estrategia de dosificación para ISB 2001, un enganche de células T trispecíficas para el tratamiento del cáncer. La investigación, publicada en Nature Cancer, utilizó ensayos virtuales para seleccionar una dosis inicial más alta, aumentando de 50 a 100 veces en comparación con los métodos convencionales. Este enfoque, aprobado por la FDA y el HREC australiano, tiene como objetivo reducir costos, minimizar dosificaciones ineficaces y acelerar el desarrollo de medicamentos.
La colaboración aprovechó la experiencia de Certara en farmacología de sistemas cuantitativos y farmacocinética basada en la fisiología para desarrollar una plataforma de ensayo clínico virtual. Este método innovador no solo mejora la seguridad y eficacia del paciente, sino que también se alinea con los objetivos regulatorios para reducir los estudios en animales. La estrategia de dosificación optimizada para ISB 2001 muestra el potencial de la tecnología de pacientes virtuales en el desarrollo de medicamentos, particularmente para biológicos complejos como los enganches de células T.
Certara (Nasdaq: CERT)와 Ichnos Glenmark Innovation (IGI)은 암 치료를 위한 트리스페시픽 T세포 인게이저 ISB 2001의 1차 임상 투여 전략 최적화에 협력했습니다. 가상 시험을 사용하여 전통적인 방법보다 50배에서 100배 더 높은 시작 용량을 선택한 연구 결과는 Nature Cancer에 발표되었습니다. 이 접근 방식은 FDA와 호주 HREC의 승인을 받아 비용을 줄이고 비효율적인 투여를 최소화하며 신약 개발을 가속화하는 것을 목표로 합니다.
이 협업은 정량적 시스템 약리학 및 생리학적 기반 약물 동력학에 대한 Certara의 전문 지식을 활용하여 가상 임상 시험 플랫폼을 개발했습니다. 이 혁신적인 방법은 환자의 안전과 효과를 향상시킬 뿐만 아니라 동물 연구를 줄이기 위한 규제 목표와도 일치합니다. ISB 2001에 대한 최적화된 투여 전략은 T세포 인게이저와 같은 복잡한 생물학적 제제의 신약 개발에서 가상 환자 기술의 잠재력을 보여줍니다.
Certara (Nasdaq: CERT) et Ichnos Glenmark Innovation (IGI) ont collaboré à l'optimisation de la stratégie de dosage pour ISB 2001, un engageur de cellules T trispecifique pour le traitement du cancer. La recherche, publiée dans Nature Cancer, a utilisé des essais virtuels pour sélectionner une dose initiale plus élevée, augmentée de 50 à 100 fois par rapport aux méthodes conventionnelles. Cette approche, approuvée par la FDA et le HREC australien, vise à réduire les coûts, minimiser les doses inefficaces et accélérer le développement de médicaments.
La collaboration a tiré parti de l'expertise de Certara en pharmacologie des systèmes quantitatifs et en pharmacocinétique basée sur la physiologie pour développer une plateforme d'essai clinique virtuel. Cette méthode innovante améliore non seulement la sécurité et l'efficacité pour les patients, mais s'aligne également sur les objectifs réglementaires visant à réduire les études animales. La stratégie de dosage optimisée pour ISB 2001 démontre le potentiel de la technologie des patients virtuels dans le développement de médicaments, notamment pour les biologiques complexes comme les engageurs de cellules T.
Certara (Nasdaq: CERT) und Ichnos Glenmark Innovation (IGI) haben zusammen an der Optimierung der ersten Dosierungsstrategie für ISB 2001, einem trispezifischen T-Zellen-Engager zur Krebsbehandlung, gearbeitet. Die Forschung, die in Nature Cancer veröffentlicht wurde, verwendete virtuelle Studien, um eine höhere Ausgangsdosis auszuwählen, die 50 bis 100 Mal höher ist als die herkömmlichen Methoden. Dieser Ansatz, der von der FDA und dem australischen HREC genehmigt wurde, zielt darauf ab, Kosten zu senken, ineffektive Dosierungen zu minimieren und die Arzneimittelentwicklung zu beschleunigen.
Die Zusammenarbeit nutzte die Expertise von Certara in quantitativer Systempharmakologie und physiologisch basierter Pharmakokinetik zur Entwicklung einer virtuellen klinischen Forschungsplattform. Diese innovative Methode verbessert nicht nur die Sicherheit und Wirksamkeit für die Patienten, sondern entspricht auch den Regulierungszielen, um Tierversuche zu reduzieren. Die optimierte Dosierungsstrategie für ISB 2001 zeigt das Potenzial der virtuellen Patiententechnologie in der Arzneimittelentwicklung, insbesondere für komplexe Biologika wie T-Zellen-Engager.
- Collaboration with IGI led to FDA and Australian HREC approval for higher starting dose of ISB 2001
- Virtual trials approach increased clinical starting dose by 50-100 fold over conventional methods
- Optimized dosing strategy reduces likelihood of exposing cancer patients to ineffective doses
- Virtual trial platform saves time and costs in drug development process
- Approach aligns with regulatory goals to reduce animal studies
- None.
Insights
This collaboration between Certara and Ichnos Glenmark Innovation (IGI) marks a significant advancement in drug development methodology. The use of virtual trials for ISB 2001, a trispecific T-cell engager, has led to a
Certara's collaboration with IGI demonstrates its strong market position in model-informed drug development. This project showcases Certara's ability to leverage its QSP and PBPK expertise to solve complex clinical challenges, potentially leading to increased demand for its services. The efficiency gains from this approach - reducing animal studies and eliminating sub-therapeutic dosing in patients - could translate to significant cost savings and faster time-to-market for drug developers. This could make Certara's services more attractive, potentially driving revenue growth. Moreover, the FDA's acceptance of this method may lead to wider adoption, expanding Certara's market. However, investors should note that while this news is positive, its impact on Certara's financials may take time to materialize as the broader industry adopts these methods.
The development of ISB 2001, a trispecific T-cell engager, represents a potential breakthrough for relapsed/refractory multiple myeloma patients. The optimized dosing strategy, resulting in a significantly higher starting dose, could lead to more effective treatment from the outset of clinical trials. This is important for patients who have exhausted other treatment options. The ability to potentially overcome immune escape mechanisms in multiple myeloma cells is particularly promising, as this is a major challenge in treating this disease. However, it's important to note that while preclinical results are encouraging, the true efficacy and safety profile will only be determined through human clinical trials. The ongoing Phase 1 trial will be critical in validating these preclinical findings and determining the actual clinical benefit for patients.
Preclinical research on the trispecific antibody, ISB 2001, published in Nature Cancer leveraged virtual trials to select a higher starting dose that would lower costs and reduce cycle times
RADNOR, Pa., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today shared the results from its collaboration with Ichnos Glenmark Innovation (IGI) on the first-in-human dose prediction and selection for ISB 2001. IGI’s drug candidate is a trispecific T-cell engager (TCE) being studied as a potential cancer treatment. Preclinical research and biosimulation findings were recently published in Nature Cancer. This publication highlighted ISB 2001’s therapeutic potential for relapsed/refractory multiple myeloma patients.
Difficulties translating data from animals to patients traditionally limit first-in-human (FIH) dose selection to the most conservative approach. IGI sought to optimize the FIH dose of ISB 2001 to maximize patient safety and efficacy. They turned to Certara to develop an innovative virtual clinical trial platform leveraging their expertise in QSP (quantitative systems pharmacology) and PBPK (physiologically-based pharmacokinetics).
“We were honored to work with IGI to develop a comprehensive biosimulation approach that allowed the team to successfully test ISB 2001 in virtual trials,” said Piet van der Graaf, PharmD, Ph.D., Senior Vice President and Head of Applied Biosimulation, Certara. “Our unique expertise and experience using virtual patients plus mechanistic modeling solutions allowed us to accelerate the speed at which ISB 2001 gets to patients. Virtual patient technology is the future of optimizing dosing for human patients.”
As a result of this collaboration, the clinical starting dose increased by approximately 50-100 fold over the conventional starting dose. Using this higher dose reduces the likelihood of exposing cancer patients to ineffective doses. Accepted by the U.S. FDA and Australian HREC, this approach paves the way for determining FIH dosing for ISB 2001 and other TCEs.
In addition, leveraging virtual trials to optimize ISB 2001 dosing saves time and costs. This efficiency is key as the industry faces mounting pressure to get drugs to patients faster. Using a more optimized dose eliminates time spent dosing patient cohorts with sub-therapeutic doses. This approach also minimizes the quantity of animal studies needed aligning with U.S. and European regulatory goals including the FDA Modernization Act 2.0.
“The collaboration with Certara was important for the success of ISB 2001," said Mario Perro, Ph.D., Head of Biologics Research, IGI. "With the innovative QSP model adapted for our trispecific T cell engager, we could predict a first-in-human dose with an acceptable safety margin that will expose fewer patients to sub-therapeutic dosing.”
To learn more about this research collaboration, please read this article, “ISB 2001 trispecific T-cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells.”
To learn more about the phase 1 clinical trial informed by this research, please refer to “Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma.”
About Certara
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries. Learn more at certara.com.
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Sheila Rocchio
sheila.rocchio@certara.com
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FAQ
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