CIO Bulletin

HiFiBiO Therapeutics – An emerging biotherapeutics company mobilizing the human immune system to combat disease

HiFiBiO Therapeutics is an emerging multinational biotherapeutics company mobilizing the human immune system to combat disease. The company integrates deep-rooted biological expertise with their comprehensive single-cell profiling technologies to rapidly discover and advance a pipeline of antibody drugs to treat cancer and autoimmune disorders. In addition, HiFiBiO Therapeutics aspires to benefit patients through open-innovation partnerships with industry and academia. HiFiBiO Therapeutics has operations in Paris, France, Cambridge, MA, USA, Hong Kong, Shanghai, and Hangzhou, China.

Sustainable Pipeline of Innovative Immunotherapies

HiFiBiO is developing next-generation immunotherapies that leverage their single-cell technologies and provide unique insights into immunomodulation. The company's sustainable pipeline of immunomodulatory antibodies targets multiple cell types and key immunosuppresive or inflammatory mechanisms for the treatment of cancer and autoimmune disease. They are currently enrolling cancer patients from DIS™ selected indications into two clinical studies. The first study is evaluating HFB200301, a first in class TNFR2 agonist monoclonal antibody (NCT05238883) and the second study is evaluating their next-generation fully human OX40 agonist monoclonal antibody HFB301001 (NCT05229601).

Drug Intelligence Science (DIS™): Transforming drug discovery and development through single-cell analytics

HiFiBiO's Drug Intelligence Science (DIS™) approach combines a unique single cell platform with AI-based data analysis from patient samples to overcome several significant challenges of drug discovery and development. This technology addresses a series of unmet needs and bottlenecks at the single-cell level through innovative solutions that allow broad immune cell profiling, functional screening, and deep sequence-based phenotypic characterization. They apply their droplet-based microfluidic technology with other cutting-edge single-cell methods for a variety of drug discovery and drug development applications.

Discovery of Novel Targets Leading to a New Generation of Precision Immunotherapies

Target selection based on key immunomodulatory pathways underlying immuno-suppression and inflammation in multiple immune cell types. HiFiBiO's target discovery approaches:

Target identification from proprietary single cell patient datasets, focused on mechanisms of resistance to current therapies
Multi-targeting strategy with novel multi-specific formats
Collaborations with top immunology/immuno-oncology experts in the world

Some Examples of Target-Based Immunotherapies include;

HFB200902 (Gal-9): Immuno-oncology

Target: Galactoside-binding lectin Galectin 9 (Gal-9) is a key pleiotropic immunosuppressive modulator present in the tumor microenvironment. High Gal-9 expression has been reported in different types of cancers including hematological malignancies and multiple solid tumors. Neutralization of Gal-9 has the potential to enhance anti-tumor immune responses in the tumor micro-environment.

Antibody: Their anti-Gal-9 blocking antibody, HFB200901, has demonstrated single agent anti-tumor activity in a mouse cancer model, offers improved survival in combination with anti-PD-1 therapy as compared to anti-PD-1 alone, and shows good tolerability in NHPs.

HFB100204 (CXCR5): Autoimmune diseases and hematological malignancies

Target: CXCR5 is a GPCR expressed on B cells, as well as on follicular helper T cells. CXCR5 plays a key role in the migration of B cells to germinal centers and the production of autoantibodies. It is implicated in several autoimmune diseases, such as Sjogren’s Syndrome, and in cancers such as B cell lymphomas and several solid cancer types, where it has been associated with metastasis and poor prognosis.

Antibody: HFB100204 is a humanized afucosylated IgG1 (ADCC enhanced) that selectively depletes CXCR5+ B and T follicular helper cells via ADCC, and potentially inhibits their migration

HFB200603 (BTLA/HVEM): Immuno-oncology and Autoimmune Disease

Target: BTLA is an inhibitory immune checkpoint expressed on B and T cells. Interaction of BTLA with its ligand, HVEM, provides an inhibitory signal to immune cells. Therefore, agonizing BTLA has the potential to dampen the immune system in auto-immune diseases, while blocking the BTLA interaction with HVEM could restore anti-tumor immunity in oncology.

Antibody: HFB200603 was identified as a single-digit nanomolar binder to human and cynomolgus BTLA, capable of reversing HVEM-mediated immune suppression in a BTLA-HVEM reporter system and in a primary CD4+ T cell proliferation assay. HFB200603 shows synergistic effect with anti-PD-1 to enhance IFN-γ production and demonstrates favorable developability and pharmacokinetic profiles.

Liang Schweizer, Ph.D. | Founder, Chairperson & CEO

Liang Schweizer is the Founder, Chairperson and Chief Executive Officer of HiFiBiO Therapeutics. She has over 30 years of research and industry experience with numerous publications and global keynote presentations. She is the co-inventor of 12 immuno-modulatory therapeutic antibodies with over 50 patent publications. She also has contributed to 4 marketed drugs and over 20 clinical candidates.

Previously, Liang co-founded Harbour Biomed and served as its CSO, successfully transforming a technology platform company to an antibody drug discovery enterprise. Before launching her entrepreneurial career, Liang served as Head of Asian Cancer Research at Sanofi, advancing Sanofi’s Asia-Pacific oncology pipeline as well as contributing to global oncology programs from preclinical to clinical efforts. Before joining Sanofi, she was a director at Bristol-Myers Squibb Company.

Liang received a B.S. from the University of Science and Technology of China (USTC) and an M.S. in Microbial Engineering and Chemical Engineering from the University of Minnesota. She earned her Ph.D. in Molecular Biology from the University in Zurich. Her postdoctoral training was with Dr. Harold Varmus, a Nobel Laureate, at Memorial Sloan Kettering Cancer Center (MSKCC).