Applied BioMath LLC

目前有 50 多种双特异性抗体正处于肿瘤学临床开发阶段，其形式多种多样，针对一系列免疫和肿瘤靶点。双特异性抗体已证明具有提高疗效和降低全身毒性的潜力。然而，双特异性抗体是一种复杂的治疗方式，在早期临床试验中需要克服诸多挑战，包括选择相关的起始剂量和剂量递增策略，这是因为暴露-效应关系并不直观;此外，细胞因子释放综合征（cytokine-release syndrome, CRS）的预测和管理也很重要。从临床前研究向临床研究的转化需要考虑多重因素，包括肿瘤生长速度、两个靶点的受体表达、靶点结合亲和力、效应细胞与靶细胞的比例、可溶性靶点的存在以及 PK 差异。机制性的定量系统药理学（quantitative systems pharmacology，QSP）模型正越来越多地用于双特异性药物的设计以及指导转化研究、临床试验设计、剂量方案优化和患者选择。 本次网络讲座将介绍双特异性抗体在肿瘤治疗中的潜力和挑战，并介绍了如何利用 QSP 模型等工具来克服这些挑战，推动双特异性抗体在肿瘤临床开发中的进一步发展。 网络研讨会对谁最有帮助： 对如何利用 QSP 模型设计新型双特异性抗体药物以及 优化现有双特异性抗体药物的发现和开发感兴趣 的制药公司科学家。 直播时间： 2024 年 6 月 25 日 19:00 - 20:00 报名方式： 点击此处 或扫描下方二维码报名 讲师 Fei Hua, PhD  建模与模拟业务副总裁，Applied BioMath（Part of Certara） Fei Hua, PhD 是 Applied BioMath（2023年被Certara收购）建模与模拟业务副总裁。主要负责与潜在客户合作，确定项目范围，并指导从早期发现到临床开发的客户项目，确保及时交付高质量的建模与模拟结果，以解决关键问题。在加入 Applied BioMath 之前，Fei 曾在辉瑞公司担任临床药理学总监。Fei 在清华大学获得生物科学学士学位，在康奈尔大学生理学系获得博士学位，随后在麻省理工学院生物医学工程系接受博士后培训。Fei 在建模与模拟领域拥有 20 多年的经验，曾在药物研发的不同阶段为肿瘤学、CVMED、免疫学、神经科学和罕见病等多个不同疾病领域的项目提供支持。Fei在如何通过建模与模拟实现数据整合和生理学理解，从而帮助解答药物开发项目中的关键问题以及节约成本和时间方面具有第一手经验。 问答环节 Certara中国区首席科学官兼全球综合药物开发部高级副总裁 李改玲博士将在线参与答疑解惑。

Combined organization establishes the life sciences industry’s largest quantitative systems pharmacology (QSP) center of excellence contributing to faster and more effective medicine development.PRINCETON, N.J., Dec. 13, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT) today announced it has acquired Applied BioMath, an industry-leader in providing model-informed drug discovery and development support to help accelerate and de-risk therapeutic research and development (R&D). Together, Certara and Applied BioMath are the life sciences industry’s largest team of experts in quantitative systems pharmacology (QSP), a method of biosimulation used across the development lifecycle to predict endpoints, biomarkers and the most effective dosing regimen. Nine out of ten new therapies that enter the clinic do not achieve regulatory approval or commercialization primarily due to lack of efficacy or unmanageable toxicity. The popularity and prevalence of the QSP methodology has grown in recent years as a strategy to de-risk drug development. QSP combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process. The resulting insights help scientists answer critical questions about novel therapies required for development progression including which patient populations are most likely to respond. “Together, Applied BioMath and Certara have the scientific and computational expertise to industrialize QSP biosimulation methods,” said William F. Feehery, CEO of Certara. “Our respective QSP businesses are complementary with regards to clients, geographic location, indications and expertise. Additionally, Certara’s existing biosimulation and AI portfolios serve as accelerators for the combined team making QSP more widely available and accessible across the industry.” “Certara’s track record of success increasing the adoption and scope of biosimulation solutions in life sciences is the ideal complement to our decade of QSP modeling experience and our proprietary QSP platform,“ said John Burke, Applied BioMath’s CoFounder, President and CEO. “The opportunity to establish the largest team of interdisciplinarian QSP scientists is exciting for the Applied BioMath team as it helps us achieve our mission of revolutionizing drug invention faster.” The newly formed QSP center of excellence further supports drug developers in the following ways. Increased Scale - Together both teams will be industrializing QSP for more types of development to enable a more efficient and insightful drug development process. Seamless Biosimulation Across Development: With numerous synergies between QSP and other types of biosimulation, the combined portfolio enhances decision-making at every stage, from preclinical research to later phase development. Biology-Focused Drug Development: As drug development becomes more biology-focused, the combined team will build more reusable models to optimize novel and combination therapies for groundbreaking results. Learn more about the value of QSP and its impact on drug development here. About Certara Certara accelerates medicines using biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,300 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Learn more at certara.com. About Applied BioMathFounded in 2013, Applied BioMath's mission is to revolutionize drug invention. Applied BioMath applies biosimulation, including quantitative systems pharmacology, PKPD, bioinformatics, machine learning, clinical pharmacology, and software solutions to provide quantitative and predictive guidance to biotechnology and pharmaceutical companies to help accelerate and de-risk therapeutic research and development. Their approach employs proprietary algorithms and software to support groups worldwide in decision-making from early research through all phases of clinical trials. The Applied BioMath team leverages their decades of expertise in biology, mathematical modeling and analysis, high-performance computing, and industry experience to help groups better understand their therapeutic, its best-in-class parameters, competitive advantages, patients, and the best path forward into and in the clinic to increase likelihood of clinical concept and proof of mechanism and decrease late stage attrition rates. For more information about Applied BioMath visit www.appliedbiomath.com. Certara Contact:Sheila Rocchiosheila.rocchio@certara.com Media Contact:Ariane LovellFinn Partnersariane.lovell@finnpartners.com

Next-generation antibody-based platform redirects endogenous cytokines to treat cancers and autoimmune diseases Proven team with deep drug development experience VANCOUVER, British Columbia--(BUSINESS WIRE)-- Reverb Therapeutics, a leader in the emerging paradigm of redirecting endogenous cytokines as treatments for life-threatening diseases, debuts with seed financing led by founding investor Amplitude Ventures and participation from the Multiple Myeloma Research Foundation’s venture philanthropy arm, the Myeloma Investment Fund. AmplifierTM Platform for redirecting cytokines Reverb Therapeutics is advancing its novel antibody-based AmplifierTM platform to treat a broad range of diseases with endogenous cytokines that naturally occur within the body. Instead of using heavily engineered exogenous cytokines to treat disease—which have consistently presented challenges such as systemic toxicity, immunogenicity and challenging production requirements—Reverb’s antibodies redirect endogenous, natural cytokines to cells of interest. This approach avoids the systemic exposure and risk of immunogenicity seen with most exogenous cytokine treatments. The company plans to use the current seed round to bring two programs to the candidate stage. Reverb’s lead pipeline programs harness IL-15 to activate specific immune cells and to target a broad variety of cancers. “We are keenly aware of the clinical obstacles to more widespread use of exogenous cytokines to treat patients,” said David de Graaf, Ph.D., Co-founder and CEO of Reverb Therapeutics. “Reverb's proprietary Amplifier antibodies utilize standard IgG frameworks along with advanced computational modeling and antibody engineering to build first-in-class novel therapeutics. The platform is designed to be modular and to use elements of existing and novel antibodies to redirect a given cytokine to a specific tumor, tissue or immune cell. It is broadly applicable across solid and liquid tumors and auto-immune diseases.” “We’re excited by the potential of Reverb’s Amplifier platform for the treatment of multiple myeloma,” said Michael Andreini, President and CEO at the MMRF. “The emerging preclinical data suggest that this highly differentiated platform approach to cytokine therapy could be promising for myeloma patients.” “There is a lot of activity in the cytokine space,” said Bharat Srinivasa, Principal at Amplitude and co-founder of Reverb. “Reverb’s proprietary Amplifier platform stands out. It is elegant and straightforward, uniquely capable of using endogenous cytokine biology to create drugs with increased efficacy.” Amplitude Ventures co-founded Reverb through its Pre-Amp venture studio program. As part of the financing, Bharat Srinivasa and Ali Tehrani, Partner at Amplitude, have joined Reverb’s board of directors. Founding team and SAB Reverb is founded and led by a team of seasoned executives with decades of experience in discovering and developing biologics. The team is responsible for more than 12 late-stage clinical programs and two marketed products. The team includes: David de Graaf, Co-founder, President and CEO is a serial biopharma entrepreneur, having co-founded and led more than 5 companies in his career from founding to late-stage clinical development. His experiences include being CEO at Abcuro, Comet (acquired by VectivBio) and Syntimmune (acquired by Alexion) and leadership roles at Apple Tree Partners, Flagship Pioneering, Pfizer, AstraZeneca and Boehringer Ingelheim. Surjit Dixit, Co-founder, CSO is an experienced science leader, and was Chief Technology Officer at Zymeworks where he conceived and directed development of the firm’s best in class Azymetric™ bispecific platform, which has generated multiple pharma partnerships and Zanidatamab, the leading biparatopic antibody being evaluated in registrational clinical trials. The company is also supported by an outstanding scientific advisory board. The SAB includes: Peter Sorger, D. Phil., Head of Therapeutic Sciences and Professor of Systems Biology at Harvard University; Fred D. Finkelman, M.D., Professor of Medicine at the University of Cincinnati College of Medicine Peter Zandstra, Ph.D., Founding Director of the School of Biomedical Engineering, University of British Columbia; John Burke, Ph.D., founder and CEO of Applied Biomath. About Reverb Therapeutics Based in Vancouver, Reverb Therapeutics is the leader in the development of treatments for cancer and other diseases using the body’s natural endogenous cytokines. Reverb’s Amplifier™ Antibody platform avoids the systemic toxicity normally associated with cytokine treatments by increasing cytokine levels only in targeted tissues. Elements of Amplifier antibodies are reusable, allowing Reverb to rapidly scale its pipeline across multiple disease areas. Learn more about opportunities to work with Reverb by contacting info@reverbtx.com About Amplitude Ventures Amplitude is a full-stack venture capital firm using a unique growth model to build companies with world-class management teams and scale companies to breakout potential. With over $500 million under management and offices in Montreal, Toronto and Vancouver, Amplitude applies a proven, evidence-based approach to investing in leading precision medicine companies. Learn more about Amplitude and its Pre-Amp venture studio at amplitudevc.com. About the Myeloma Investment Fund The Myeloma Investment Fund is a venture philanthropy fund that invests in promising companies, clinical assets, and technologies in oncology to drive the development of new therapies for multiple myeloma. The MIF collaborates closely with portfolio companies to help them advance multiple myeloma research. This evergreen fund is supported entirely by philanthropy; all profits will be reinvested back into research for more effective treatments until there is a cure for every patient. For more information, visit .