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
3010
2003
3013
2009
1002
1011
2005
2006
2008
2012
Immune Stimulatory PathwaysInfectious DiseaseCell DepletingImmune Suppressive Pathways
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 Announcements
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 Announcements
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
IND Enabling Studies
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
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 Announcements
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 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

 

HFB2005 is an inhibitory immune checkpoint. Its expression on tumor cells inhibits T cell functions in the tumor microenvironment. HFB2005 has been shown to be highly expressed on certain type of tumors. Patients with high levels of HFB2005 expression on tumor cells have a poorer prognosis.

 

We have identified potent binders capable of blocking the interaction of ligand to its relevant receptors.

 

 

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
Lead Antibody Identification
Mechanism of Action
Cell Depleting
Overview

Immuno-oncology

 

HFB2008 is a potential novel marker of Myeloid-Derived Suppressor Cells (MDSCs), also expressed on multiple different tumor cell types including kidney and liver cancer cells. MDSCs are immunosuppressive cells present in the tumor microenvironment in a wide range of cancers and depleting them offers an attractive strategy for promoting anti-tumor immunity that may be complementary to approaches currently used in the clinic.

 

 

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

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