Pipeline
Pipeline
Sustainable Pipeline of Innovative Immunotherapies
We are developing next-generation immunotherapies that leverage our single-cell technologies and provide unique insights into immunomodulation.
Our sustainable pipeline of immunomodulatory antibodies targets multiple cell types and key immunosuppresive or inflammatory mechanisms for the treatment of cancer and autoimmune disease.
Our Pipeline
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Mechanism of Action
Overview
COVID19
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.
We are developing an anti-SARS-CoV2 antibody, HFB30132A, isolated from the blood of a COVID-19 convalescent patient that binds the viral Spike protein and demonstrates strong neutralization of live virus infection of mammalian host cells.
Research published in Nature Biotechnology shows how single-cell microfluidic technology can rapidly reveal previously hidden immune responses, with potential applications in multiple disease areas including COVID-19…Read more
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Mechanism of Action
Overview
Immuno-oncology
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.
HFB301001 is under development as a potential novel treatment option for cancer coupled with patient stratification biomarkers in solid tumor indications.
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Mechanism of Action
Overview
Immuno-oncology
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.
We are developing an anti-TNFR2 monoclonal antibody, HFB200301, as a first-in-class therapeutic capable of co-stimulating T cell proliferation and displaying strong in-vivo anti-tumor immunity and good tolerability for the treatment of biomarker selected patients with advanced cancer.
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Mechanism of Action
Overview
Immuno-oncology
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.
We are developing an anti-Gal-9 neutralizing antibody with single agent and combination anti-tumor activity and with potential as a first-in-class treatment for AML and solid tumors.
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Mechanism of Action
Overview
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.
We have identified potent binders capable of blocking B cell migration and stimulating cell killing via ADCC, with potent in vivo activity.
Mining the antibody repertoire of plasma cells and plasmablasts could enable the discovery of useful antibodies for therapeutic or research purposes…Read more
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Mechanism of Action
Overview
Immuno-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.
We have identified potent binders capable of stimulating cell killing via ADCC and blocking the binding of the HFB1011 immunosuppresive ligand.
Mining the antibody repertoire of plasma cells and plasmablasts could enable the discovery of useful antibodies for therapeutic or research purposes…Read more
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Mechanism of Action
Overview
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.
We have identified potent binders capable of blocking the interaction of ligand to its relevant receptor.
Mining the antibody repertoire of plasma cells and plasmablasts could enable the discovery of useful antibodies for therapeutic or research purposes…Read more
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Mechanism of Action
Overview
Immuno-oncology
HFB2012 is expressed on tumor cells and suppresses tumor cell killing by innate immune cells through an inhibitory signal that inhibits phagocytosis. Blockade of HFB2012 interaction with its ligand is expected to restore anti-tumor innate immunity.
Mining the antibody repertoire of plasma cells and plasmablasts could enable the discovery of useful antibodies for therapeutic or research purposes…Read more
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Mechanism of Action
Overview
Early stage program focused on multiple mechanisms of immune modulation
Stage
Mechanism of Action
Overview
Early stage program focused on multiple mechanisms of immune modulation
Discovery of Novel Targets Leading to a New Generation of Precision Immunotherapies
We take a multi-faceted approach to target the immune system, including key immunosuppressive cell types, suppressive and stimulatory pathways, and pleiotropic immune modulators, to shift the immune balance in cancer and autoimmune diseases.
Our target discovery approaches:
- Profiling of patient samples using our Drug Intelligent Science (DIS™) single-cell capabilities
- Collaborations with leading immunology and oncology key opinion leaders
- Target deconvolution using patients’ antibody repertoires
