Abstract 1537: DRIVE-Biologics: All the steps from discovery to development of novel biological entities

• Published in: Cancer research (Chicago, Ill.) Ill.), 2023-04, Vol.83 (7_Supplement), p.1537-1537
• Main Authors: Fang, Emily, Bunce, Campbell, Payne, Philip, Teran, Rafael, Duchamp, Olivier, Mignard, Caroline, Bichat, Francis, Viviani, Fabrice
• Format: Article
• Language: English
• ISSN: 1538-7445; 1538-7445
• DOI: 10.1158/1538-7445.AM2023-1537

Biologics first revolutionized cancer treatment in the late 1900s with the approval of rituximab and trastuzumab, two monoclonal antibodies targeting antigens expressed on tumor cells. Another milestone was achieved in the early 2010s with the approval of antibodies targeting immune checkpoints. Nowadays, the discovery and development of new biological entities and biological therapeutic products represent a rapidly growing market in various therapeutic areas, with about 10 to 15 biologics being approved each year. We have built a premium expert ecosystem services - DRIVE-Biologics - to support and accelerate biologics drug discovery and development in oncology, immuno-oncology, and inflammatory diseases. The DRIVE-Biologics consortium provides a unique integrated solution with specialist services from strategic partners, to access market analysis, establish the ability to design, optimize, and develop novel biological entities addressing the therapeutic target of interest. DRIVE-Biologics supplies the high-level, IND-focused discipline to rigorously manage the integrated programs integrating CMC, manufacturing, regulatory affairs and clinical trial. We will present the lead optimization and multiparameter preclinical evaluation process to select and assess biological candidates for downstream development and clinical studies: Custom cellular model development for discovery and potency analysis; In vitro screening, target engagement, and mechanism of action elucidation with cellular models ranging from tumor cell lines, immune cells or primary patient samples; In vivo efficacy and safety studies using refined and highly characterized syngeneic, xenogeneic, patient-derived xenograft or humanized mouse models up to non-human primates; DMPK capabilities to develop and validate bioanalytical methods (including GLP-compliancy) such as LBA and qPCR/RT-qPCR and also assess immunogenicity; Biodistribution and tumor specificity analysis of bioconjugated and radiolabeled biologics. Herein, we provide DRIVE-BIO optimization and preclinical evaluation process to select promising biologics and list the key parameters to be checked. We will present our recent results which highlight the importance to optimize these parameters to improve the efficacy of biologics. Citation Format: Emily Fang, Campbell Bunce, Philip Payne, Rafael Teran, Olivier Duchamp, Caroline Mignard, Francis Bichat, Fabrice Viviani. DRIVE-Biologics: All the steps from discovery to development of novel