50以上の二重特異性抗体が、さまざまなフォーマットで、幅広い免疫および腫瘍ターゲットを対象として、がん領域の臨床開発に取り組まれています。Bispecifics have demonstrated the potential for enhanced efficacy and reduced systemic toxicity. However, they are complex modalities with challenges to overcome in early clinical trials, including selection of relevant starting doses and dose escalation strategy due to non-intuitive exposure-response relationships. In this context, prediction and management of cytokine-release syndrome (CRS) is important.
Multiple factors can contribute to between-patient variability, including tumor type, avidity, receptor expression, effector-to-target-cell ratio, and presence of soluble target.
Mechanistic, quantitative systems pharmacology (QSP) models are increasingly being used in the design of bispecifics and to guide translation research, clinical trial design, dose regimen optimization, and patient selection.
Following a general introduction, we shared a case study on using model-informed clinical development to unlock the therapeutic potential of mosunetuzumab (a CD20/CD3 bispecific antibody) to illustrate the application of QSP in drug development and regulatory decision-making.
Our Speakers
Piet van der Graaf, Senior Vice President, Quantitative Systems Pharmacology
製薬業界（SanofiおよびPfizer）において20 年以上の経験があります。QSPプロジェクトに重要な技術と経験をもたらし、サターラの戦略的な開発に貢献しています。また、「CPT : Pharmacometrics & Systems Pharmacology (ファーマコメトリクスおよびシステム薬理学)」の編集責任者でもあります。
Chi-Chung Li, Principal Scientist at Genentech
Chi has 13 years in clinical drug development experience and specializes in quantitative clinical pharmacology of small molecule pharmaceuticals and biologics. She supported development of molecules across a broad spectrum of therapeutic areas including cancer immunology, neuroscience, infectious disease, cardiovascular diseases, and respiratory/immunology. She joined Genentech in 2014 and has served as the clinical pharmacology lead of several immuno-oncology molecules, including atezolizumab, anti-OX40, personalized cancer vaccine, and mosunetuzumab (aCD20/CD3 bispecific antibody). She currently leads the Immune Cell Bispecifics platform strategy in Clinical Pharmacology at Genentech. She is passionate in promoting science-driven drug development to maximize benefit-risk of therapeutic modalities and accelerate/enhance access to anti-cancer therapies.
