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

Target Evaluation
Antibody Discovery
Lead Antibody Identification
Clinical Candidate Selection
IND Enabling Studies
Phase 1
Phase II
Phase III
HFB3013 The coronavirus SARS-CoV-2 and the COVID-19 disease caused by it has rapidly emerged as a serious threat to global public health.
HFB3010HFB301001 is a novel fully human IgG1 class OX-40 agonistic antibody with an optimized pharmacological profile.
HFB2003TNFR2 is a TNF receptor family member expressed on effector and regulatory T cells.
HFB2009Galactoside-binding lectin Galectin 9 (Gal-9) is a key pleiotropic immunosuppressive modulator present in the tumor microenvironment.
HFB1002HFB1002 is a GPCR expressed on B cells, as well as on follicular helper T cells.
HFB1011HFB1011 is a GPCR with prevalent and highly specific expression on immunosuppressive tumor infiltrating regulatory T cells (Tregs) across different tumor types.
HFB2006HFB2006 is an inhibitory immune checkpoint expressed on B and T cells. Interaction of HFB2006 with its ligand provides an inhibitory signal to immune cells.
HFB2012HFB2012 is expressed on tumor cells and suppresses tumor cell killing by innate immune cells through an inhibitory signal that inhibits phagocytosis.
HFB1014Early stage program focused on multiple mechanisms of immune modulation
HFB2015Early stage program focused on multiple mechanisms of immune modulation
Immune Stimulatory PathwaysInfectious DiseaseCell DepletingImmune Suppressive Pathways
Stage
Phase 1
Mechanism of Action
Infectious Disease
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.

Related News
Droplet Microfluidic Screening and Sequencing Can Vastly Expand the Universe of New Antibody Therapeutics

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

 

Stage
IND Enabling Studies
Mechanism of Action
Immune Stimulatory Pathways
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.

Related Announcement
Clinical approach and biomarker strategy for HFB301001, a novel OX40 agonistic antibody
Presenters: Ross Fulton, Jinping Gan, Yun-Yueh Lu, Julianna Crivello, Zachery Duda, Zhiyuan Wang, Rebecca Silver, Alexandra Staskus, Charina Ortega, Sami Ellouze, Carine George, Sophie Foulon, Wenhua Xu, Xing Cai, Joyce Pi, Dean Lee, Monika Manne, Ruina Jin, Yuan Wang, Hongkai Zhang, Nicola Beltraminelli, Francisco Adrian, Robert Petit, Liang Schweizer, Andreas Raue. Read more
Related Announcement
HFB301001, a novel OX40 agonistic antibody with a unique pharmacological profile and innovative biomarker strategy
Presenters: Andreas Raue, PhD, Project Leader, Senior Director, Head of Drug Intelligent Science (DIS™) at HiFiBiO Therapeutics and Robert Petit, PhD, Senior Scientific Advisor.  Read more

 

Stage
IND Enabling Studies
Mechanism of Action
Immune Stimulatory Pathways
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.

Related Announcement
Mechanism of Action and Biomarker Strategy for HFB200301, an Anti-TNFR2 Agonist Antibody for the Treatment of Cancer
Presenters: Shuo Wei, Ross Fulton, Yun-Yueh Lu, Qian Zhang, He Zhou, Andreas Raue, Mingjie Chen, Wenhua Xu, Xing Cai, Juliana Crivello, Zachary Duda, Zhiyuan Wang, Rebecca Silver, Alexandra Staskus, Charina Ortega, Sami Ellouze, Carine George, Sophie Foulon, Dean Lee, Monika Manne, Nicola Beltraminelli, Jinping Gan, Francisco Adrian, Liang Schweizer, Jennifer Watkins-Yoon. Read more
Related Announcement
Discovery and characterization of novel TNFR2 antibodies to modulate T cell activities in immunosuppressive environment
Presenters: Francisco Adrian, PhD, Senior Vice President, Head of Research and Shuo Wei, PhD, Project Leader, Principal Scientist, Disease Biology. Read more
Stage
Clinical Candidate Selection
Mechanism of Action
Immune Suppressive Pathways
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.

Related Announcement
HFB9-2, a novel Galectin 9 neutralizing antibody for the treatment of AML and other cancers
Presenters: Germain Margall, Muriel David, Julie Prigent, Dean Lee, Wenhua Xu, Joyce Pi, Xing Cai, Tengfei Wang, Ouyang Li, He Zhou, Andreas Raue, Nicola Beltraminelli, Mingjie Chen, Jia Wu, Mingfang Feng, Angelo Paci, Julia Delahousse, Véronique Saada, Stéphane de Botton, Pierre Busson, Stephanie Beq, Francisco Adrian, Liang Schweizer, Yun-Yueh Lu. Read more
Related Announcement
HFB9-2, a novel Galectin-9 neutralizing antibody to reverse immune suppression in the tumor microenvironment
Presenters: Roshan Kumar, PhD, Senior Director, Head of Discovery Biology and US External Innovation and Yun-Yueh Lu, PhD, Project Leader, Principal Scientist, Disease Biology. Read more
Stage
Clinical Candidate Selection
Mechanism of Action
Cell Depleting
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.

Related Announcement
Discovery and characterization of a novel anti-human CXCR5 antibody for the treatment of B cell lymphomas
Presenters: Ayrin Kök, Germain Margallducos, Stephanie Beq, Clarisse Monchecourt, Hombline Poullain, Muriel David, Sami Ellouze, Carine George, Mingjie Chen, Yun-Yueh Lu, Juying Li, Qian Zhang, Jean Wang, Adam Woolfe, Louise Gody, Francisco Adrian, Liang Schweizer, Nicola Beltraminelli. Read more
Related Article
High-throughput single-cell activity-based screening and sequencing of antibodies using droplet microfluidics

Mining the antibody repertoire of plasma cells and plasmablasts could enable the discovery of useful antibodies for therapeutic or research purposes…Read more

Stage
Clinical Candidate Selection
Mechanism of Action
Cell Depleting
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.

Related Article
High-throughput single-cell activity-based screening and sequencing of antibodies using droplet microfluidics

Mining the antibody repertoire of plasma cells and plasmablasts could enable the discovery of useful antibodies for therapeutic or research purposes…Read more

Stage
Clinical Candidate Selection
Mechanism of Action
Immune Suppressive Pathways
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.

Related Article
High-throughput single-cell activity-based screening and sequencing of antibodies using droplet microfluidics

Mining the antibody repertoire of plasma cells and plasmablasts could enable the discovery of useful antibodies for therapeutic or research purposes…Read more

Stage
Antibody Discovery
Mechanism of Action
Immune Suppressive Pathways
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.

Related Article
High-throughput single-cell activity-based screening and sequencing of antibodies using droplet microfluidics

Mining the antibody repertoire of plasma cells and plasmablasts could enable the discovery of useful antibodies for therapeutic or research purposes…Read more

Stage
Antibody Discovery
Mechanism of Action
Immune Stimulatory Pathways
Overview

 

Early stage program focused on multiple mechanisms of immune modulation

Stage
Antibody Discovery
Mechanism of Action
Immune Stimulatory Pathways
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