HiFiBiO Therapeutics is an emerging multinational biotherapeutics company mobilizing the human immune system to combat disease. The company integrates deep-rooted biological expertise with our 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.
Microfluidics Single-cell Antibodies
TechnologiesAI Companies (Drug Discovery)
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Drug Intelligent Science (DIS™)
Transforming drug discovery and development through single-cell analytics
We are transforming discovery and development by combining our Data Intelligence with our Single-Cell Science to achieve optimal outcomes for target discovery, drug candidate identification, lead optimization, and patient selection.
The coronavirus SARS-CoV-2 and the COVID-19 disease caused by it has rapidly emerged as a serious threat to global public health. HiFiBiO has committed to a humanitarian effort for the rapid identification and development of antibodies against SARS-CoV-2 to both treat infected patients and prevent the spread of the infection. Our SARS-CoV-2 neutralizing candidate antibody, HFB30132A, binds the viral Spike protein with sub-nM affinity and potently blocks the binding to the human receptor ACE2 and the infection of mammalian epithelial cells by live virus.
HFB301001 is a novel fully human IgG1 class OX-40 agonistic antibody with an optimized pharmacological profile. In contrast to other anti-OX-40 antibodies, the agonistic activity of HFB301001 is further enhanced in the presence of the endogenous ligand OX-40L and does not result in reduced expression of OX-40 on T cells. HFB301001 demonstrated superior anti-tumor activity in a human OX-40 knock-in mouse model compared to a competitor antibody and is positioned as a best-in-class differentiated molecule for potentially better clinical activity. Identification of a biomarker predictive of response to HFB301001 is ongoing using HiFiBiO’s proprietary Drug Intelligent Science (DIS™) platform.
TNFR2 is a TNF receptor family member expressed on effector and regulatory T cells. , In tumors, TNFR2 is expressed more broadly on activated and exhausted T cells than other T cell costimulatory receptors. Therefore, targeting TNFR2 is anticipated to yield greater anti-tumor immunity by stimulating T-cell activation and proliferation in the tumor microenvironment than targeting other costimulatory receptors. Our First-in-Class agonistic anti-TNFR2 candidate antibody, HFB200301, binds potently and selectively to TNFR2, recognizes cyno TNFR2, and induces CD4 and CD8 T cell activation and proliferation cooperatively with TNFα without requiring crosslinking. In vivo, HFB200301 demonstrates potent antitumor activity alone and combined with anti-PD-1 and is well tolerated in mouse and NHPs.
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 such as Acute Myeloid Leukemia (AML) and Acute Lymphocytic Leukemia (ALL), and multiple solid tumors. Neutralization of Gal-9 has the potential to enhance anti-tumor immune responses in the tumor micro-environment. Our 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.
Autoimmune diseases and hematological malignancies
HFB1002 is a GPCR expressed on B cells, as well as on follicular helper T cells. HFB1002 plays a key role in the migration of B cells to germinal centers and the production of autoantibodies. HFB1002 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.
Immuno-oncology and Autoimmune Disease
HFB2006 is an inhibitory immune checkpoint expressed on B and T cells. Interaction of HFB2006 with its ligand provides an inhibitory signal to immune cells. Therefore, agonizing HFB2006 has the potential to dampen the immune system in auto-immune diseases, while blocking the HFB2006 interaction with its ligand could restore anti-tumor immunity in oncology.
HFB1011 is a GPCR with prevalent and highly specific expression on immunosuppressive tumor infiltrating regulatory T cells (Tregs) across different tumor types. Stimulation of HFB1011 by its ligand results in proliferation of Tregs in the tumor microenvironment and immune-suppression. Targeting and blockade by monoclonal antibodies of the mouse ortholog has shown anti-tumor activity in various syngeneic models. Targeting HFB1011 with an antibody able to mediate cell killing through antibody-dependent cellular cytotoxicity (ADCC) offers the potential to selectively deplete highly immunosuppressive Tregs in the tumor microenvironment and promote anti-tumor immunity.
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