Sébastien Wieckowski

▪ Leading a multi-modality R&D strategy focused on platform innovation and the integration of translational programs into global regulatory milestones ▪ Safeguarding IP assets and directing capital strategy to stabilize R&D during complex global transitions

▪ Provided essential technical oversight and R&D stabilization during the successful public market transition ▪ Oversaw the CMC and Quality strategy for live biotherapeutics, including the design of innovative oral formulations for DNA vaccines ▪ Managed a global network of internal teams and decentralized CROs/CDMOs to ensure preclinical and translational integrity through rigorous data standards

▪ Accredited for the French Research Tax Credit (CIR): officially recognized by the French Ministry of Higher Education & Research to provide high-level R&D consulting services with significant fiscal advantages for clients ▪ Providing high-level R&D consulting and objective due diligence through a truthful examination of raw data for M&A and investment evaluations ▪ Deploying applied AI and Python-based pipelines to automate experimental analysis, ensuring the highest standards of research integrity for biotech clients

▪ Directed the preclinical lifecycle for a diverse portfolio including small molecules, peptides, and biologics ▪ Established GLP IND-enabling programs for lead candidates in ophthalmology and successfully extended packages to support Phase IIa trials in autoimmune and allergy indications ▪ Authored and defended critical regulatory documentation for the FDA, EMA, and CDE (China), including Investigator Brochures and CTD Modules

▪ Acted as a strategic consultant between R&D and Technical Development (PTDE), facilitating the transfer of human immunobiology techniques to support high-priority assets like gantenerumab and glofitamab ▪ Led the transition of artisanal cell-based assays into standardized, robotic, and GMP-compliant workflows, significantly enhancing throughput and data reproducibility

▪ Responsible for personalized neoantigen vaccine assembly for the NECVAXNEO1 clinical trial ▪ Applied machine learning for epitope assembly and neoantigen discovery using NGS-derived data

▪ Directed R&D and nonclinical development of the VXM oral T-cell vaccine platform (VXM01, VXM04, VXM06, VXM10) ▪ Spearheaded the development of a clinical-stage neoantigen asset (NECVAXNEO1) derived from a proprietary platform licensed to NEC ▪ Supervised GCLP immunomonitoring and histopathology for Glioblastoma (GBM) Phase I/II clinical trials while managing international CRO partnerships ▪ Led Business Development efforts (industry and academic collaborations)

▪ Assessed novel tumor stroma-targeted IL-2-variant immunocytokines, combining them with immune checkpoint inhibitors in genetically engineered mouse models (GEMM) of lung cancer (Lab: Prof. Zippelius/Dr. Klein) ▪ Served as Deputy Study Director for animal licenses and established high-impact collaborations with ETHZ, MGH, and CureVac

▪ Characterized T-cell responses in melanoma patients following therapeutic vaccination using single-cell analysis and TCR sequencing (Lab: Prof. Romero) ▪ Mentored and supervised undergraduate/graduate students and technical staff in advanced laboratory techniques

▪ Spearheaded a national initiative focused on the transduction of human dendritic cells using adenoviral vectors to enhance the presentation of HIV-1 epitopes ▪ Orchestrated a long-term collaborative project with the Laboratory of Virology & Viral Pathogenesis, focusing on potentiating anti-HIV-1 immune responses

▪ Innovated functional CD40L mimetics utilizing C3-symmetric peptide scaffolds, working at the high-impact interface of organic chemistry and immunology ▪ Served as Lab Manager within the Immunologie et Chimie Thérapeutiques group at the IBMC (Lab: Prof. Muller; Member of the French Academy of Sciences), overseeing daily operations and technical infrastructure ▪ Mentored and trained a diverse group of students and technical staff in advanced laboratory techniques

▪ Instructed B.Sc. biochemistry students in immunology laboratory practices (travaux pratiques), focusing on experimental design and data interpretation ▪ Prepared and taught classroom-based courses (travaux dirigés) in immunobiology for foundational biology degrees

M.Sc. in Biochemistry and Organic Chemistry B.Sc. in Biochemistry and Bioinformatics; Mention Très Bien (Summa Cum Laude)