Hongxia Zhang

At Century Therapeutics, I spearheaded the translational development of innovative cell therapies (iPSC-derived, gene edited, allogenic CAR-T/CAR-NK) targeting autoimmune diseases and cancer. My role involved crafting and executing translational strategies, particularly for CALiPSO-1, a phase 1 autoimmune basket trial. I led a dedicated team in immunogenicity/functional immunological assessments, fostering innovation and collaboration in a fast-paced biotech environment. I also drove external publications and presentations, establishing our scientific leadership in the field.

In my role at GSK, I led the translational strategy for multiple oncology programs, focusing on biomarker development and trial optimization. I spearheaded several high-impact translational initiatives that informed early clinical development strategies, such as novel patient selection/CDx strategy, indication prioritization, and dose finding algorithm (by creating a quantifiable PD model). In addition, I successfully supported start-up activities for the first in-house solid tumor CAR-T trial, including contribution to the IND milestone. My efforts in mentoring junior biomarker leads and managing resources contributed to the overall success of our clinical trials.

• Integrated translational research and clinical development: Developed clinical biomarker strategy and delivered high quality biomarker targets: - Developed assays to inform patient selection, PK/PD, and dose & schedule design - Supported CDx development for early- and late-stage clinical trials. - Drove data generation, in-depth analysis, and provided interpretation key to decision making - Wrote protocols/ICF/SIV/CSR documents. Supported IND filings. • Developed translational strategies for both solid tumor and heme malignancies. Drove translational investigations essential for clinical applications: Identified questions, composed research proposal, designed experiments and led matrixed team to accomplish goals. • Spearheaded rational combination strategy: Applied novel theory and composed proposals for “cold” and IO-refractory tumors. • Championed biomarker discovery and assay design by employing emerging technologies. Effectively engaged diverse technology groups to develop new assays for biomarker exploration. • Collaborated with internal and external stakeholders. Managed scientific collaboration with KOLs. Extended internal capabilities through interaction with CROs.

• Led the analytical flow cytometry platform in Teva biomarker development laboratory. Established instrument and assay requirements for flow cytometry-based method validation. Demonstrated in-house flow cytometry capability for semi-quantitative and quantitative biomarker analysis. • Conducted translational studies in Immuno-oncology, inflammatory and neurological diseases. Led the development of multiple clinical biomarker assays for patient stratification, target engagement, pharmacodynamics, diagnostic and safety applications. • Implemented fit-for-purpose biomarker approaches, composed biomarker proposals/plans, conducted assay development, wrote SOPs, managed CROs, and collaborated with a broad range of functional teams and stakeholders.

• Initiated and led multiple immunotherapy discovery programs, including cancer vaccine and adjuvants, bispecific antibodies/TCE, immune checkpoint blockade, ADC, and T cell agonists. • Demonstrated track record of success in directing preclinical studies, including small and large molecule efficacy testing, PK/PD study, and combination therapy. • Expertise in immunotherapy model development and ex vivo MOA investigation. • Expertise in the development of a broad array of functional, biochemical and immunological assays. • Published research results and filed patent applications.

• Developed several antibody therapeutic programs targeting both neoplastic cells and tumor microenvironment. Provided key results to support Go/No-Go decisions. • Expertise in Target identification, validation and MOA studies. • Expertise in immunohistochemistry and successfully managed internal and external studies. • Established automated IHC platform and real time cell imaging system and trained multiple personnel.

• Conducted cancer immunology research in understanding the connection between tumor-associated macrophages, hypoxia, and cancer. • In-depth investigation on the role of hypoxia-inducible factors (HIFs) in macrophage functions.

Research Area: Molecular Immunology

Research Area: Therapeutic Protein