Hongyu Tian

- Project team leader for a Phase II clinical trial focused on elucidating the MoA of AHB-137, a leading ASO therapeutic for functional cure of chronic hepatitis B (CHB), with an emphasis on immune modification. - Project team leader for a preclinical collaboration with an overseas KOL lab on translational research to uncover the MoA of the company lead ASO therapeutic in HBV clearance, focusing on modulation of the hepatic immune system using ex vivo model. - Designed and authored the biomarker strategy for the clinical trial protocol and regulatory submission. - Execute clinical biomarker studies to elucidate the MoA of AHB-137 through integrated virology and immunology analysis in peripheral blood and liver biopsy using both conventional assays and multi-omics approaches (scRNA-seq, CyTOF, spatial transcriptomics, Olink, proteomics). - Provide strategic oversight of CRO partnerships, including evaluation, selection, contracting, and performance management of ten CROs. Oversee assay validation and optimization, sample logistics, data transfer, troubleshooting, and compliance. Ensure smooth execution, timely deliverables, and high-quality data generation across biomarker studies. - Develop biomarker analysis strategies to identify predictive, PD and resistent biomarkers to support clinical development.

Lead clinical biomarker studies for Phase I anti-LILRB2 (a checkpoint on myeloid cells) in solid tumor indications. - Designed biomarker strategies, authored and reviewed biomarker plans in clinical trial protocols and regulatory documents. - Developed clinical biomarker assays, outsourced the validated assays to CROs. - Selected CROs, managed them for performing different biomarker analysis—held weekly or ad hoc communication meetings, emailing, sample QC, data interpretation, document revising, etc. - Collaborated with bioinformatics scientists to mine gene expression data, having identified pharmacodynamic biomarkers that reflect the MoA of anti-LILRB2/anti-PD-1, and baseline predictive biomarkers correlated with clinical responses. - Participated in strategic discussions on applying biomarker learning and target biology to indication selection. - Proficient user of public RNAseq databases including TISCH scRNAseq database, cancer TCGA bulk RNAseq database, Gene Expression Omnibus (GEO) database, Human Protein Atlas, etc; knowing how to obtain useful information from these datasets to be applied in biomarker learning. - Key contributor to the biomarker section of a manuscript about the anti-LILRB2 in phase I trial. Lead multiple translational research focused on immuno-oncology and autoimmune disease indications. - Led an anti-CD3 bispecific T cell engager translational study program (myeloid targeted). Studied target expression analysis across indications, investigated pharmacodynamic MOA, assessed pharmacokinetics and toxicity, and discovered predictive biomarkers for indication/patient selection. - Conducted translational research for an antibody targeted on pDC as a therapeutics for treating lupus and supported regulatory documents writing for pre-IND meeting.

Lead multiple multiple drug discovery programs and collaboration effort - Discovery lead for an anti-CD3 bispecific T cell engager program (myeloid targeted). Validated target and developed bioassays for lead selection. - Biology lead for validating stroma modulator, DDR1, as a possible cancer target for antibody therapeutics. - Conducted translational research for combining an antibody against a myeloid cell surface molecule with anti-CD47 in a collaboration with a pharma company. - Successfully managed or collaborated with internal and external stakeholders including academic partners and CROs, as well as supervised laboratory staff.

Discovery lead for a novel immune checkpoint project targeting B7H4 that spans target validation and antibody discovery from A to Z. The effort led to selection of a lead panel of antibodies. Considerable experience in working with antibody engineering scientists for lead optimization.

- Served as principal investigator exploring tumor microenvironment roles in tumor progression, focusing on tumor-secreted proteins, tumor-associated angiogenesis, and tumor-infiltrated immune cells for novel therapy development. - Initiated projects, securing grants from NIH, DoD, Susan G. Komen, and Cure HHT foundations; successfully funded by Susan G. Komen and Cure HHT as principal investigator. - Discovered and validated preclinical targets and biomarkers in breast cancer microenvironment regulating the TGF-beta pathway. - Investigated fibulin-3 and βIGH3 roles in tumor progression through loss/gain function in cell-based models and xenograft mouse model. - Explored endoglin's roles in tumor-associated angiogenesis and Hereditary Hemorrhagic Telangiectasia. - Developed and tested novel therapies (bevacizumab and TRC105 combination) using in vitro assays and in vivo murine models. - Explored tumor hypoxia-induced VEGF regulation of immune checkpoint ligands for novel anti-angiogenesis and immune checkpoints therapy. - Conducted hands-on experiments: cell-based analysis, biochemistry assays, molecular biology assays, in vivo xenograft, and syngeneic mouse models. - Led three projects, mentoring junior staff, fostering collaborations, presenting at domestic/international conferences, and publishing as the first author in Oncogene (2015), ATVB (2017), and The FASEB J (2018).

- Received a Susan G. Komen Postdoctoral Fellowship grant for identifying novel TGF-β regulators in the breast cancer microenvironment. - Initiated and secured grants from DoD and Susan G. Komen, receiving $180,000 (2011-2014) from Susan G. Komen for the postdoctoral fellowship. - Established tools for screening and identifying tumor-secreted proteins regulating the TGF-beta pathway. - Developed in vitro cell models for studying various steps of tumor-associated angiogenesis. - Collaborated internally and externally with other labs to enhance research outcomes. - Presented projects at international and domestic conferences and published data as the first author in The EMBO Journal, a top-tier journal.