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

Program
Indication
Antibody Discovery
Preclinical Development
Phase 1
Phase 2
Phase 3
HFB200301 Solid Tumors
HFB301001 Solid Tumors
HFB200603 Solid Tumors
HFB200902 Myeloid Malignancies/
Solid Tumors
HFB101110 Solid Tumors
HFB100204 Autoimmune Disease/Cancer
HFB2006 AID Autoimmune Disease
3+ Bispecifics Solid Tumors

We are exploring strategic partnerships for Enuzovimab (HFB30132A), a Delta variant active SARS-COV-2 neutralizing antibody with a completed Ph I healthy volunteer trial. Read more

Immune Stimulatory PathwaysCell DepletingImmune Suppressive Pathways
Stage
Phase 1
Mechanism of Action
Immune Stimulatory Pathways
Overview

Immuno-oncology

 

Target

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.

Antibody

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 Non-Human Primates.

Clinical Trial Information

The ongoing first-in-human dose escalation study enrolls patients with DIS™ selected advanced cancers. Once a recommended dose for expansion is achieved, the study will expand into cohorts for specific cancer types. Identification of biomarkers predictive of response is also being performed. For more information, visit www.clinicaltrials.gov (NCT05238883).
 

Related Announcement
HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200301
HFB200301 is a First-In-Class TNFR2 Agonist Antibody for the treatment of DIS™ Defined Solid Tumors… Read more
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
Related Announcement
HiFiBiO Therapeutics to Present Trial in Progress Poster for HFB200301 at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting
HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, announced today that clinical trial investigator, Alexander I Spira, MD, PhD, FACP, Co-Director of the Virginia Cancer Specialists (VCS) Research Institute and Director of the Thoracic and Phase I Program, will present a Trials in Progress Poster… Read more
Stage
Phase 1
Mechanism of Action
Immune Stimulatory Pathways
Overview

Immuno-oncology

 

Target

OX-40 (CD134, TNFRSF4) is a tumor necrosis factor (TNF) receptor expressed primarily on activated CD4+ and CD8+ T cells and transmits a potent costimulatory signal when engaged. Targeting OX40 with an agonistic antibody has been demonstrated to increase the activity of T cells leading to anti-tumor responses. Several agonistic antibodies against OX40 have been evaluated in the clinical trials with good tolerability. However, so far, limited clinical activities have been observed in the reported clinical trials.

Antibody

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 enhanced clinical activity.

Clinical Trial Information

The first-in-human dose escalation study will enroll patients with DIS™ selected advanced cancers. Once a recommended dose for expansion is achieved, the study will expand into cohorts for specific cancer types. For more information, visit www.clinicaltrials.gov (NCT05229601)

 

Related Announcement
HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB301001
HFB301001 is a potential best-in-class OX40 agonist antibody for the treatment of DIS™ defined solid tumors. Read more
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
Preclinical Development
Mechanism of Action
Immune Suppressive Pathways
Overview

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.

 

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

Related Article
HiFiBiO Therapeutics Announces Three Presentations at 2022 American Association for Cancer Research (AACR) Annual Meeting

We are excited to share with the oncology research community at AACR updates for two of our preclinical development programs – HFB200603, a novel anti-BTLA blocking antibody on track for IND submission, and HFB101110, an anti-CCR8 depleting antibody that was recently licensed to FibroGen…Read more

Related Article
HFB200603, a novel anti-BTLA monoclonal antibody that provides therapeutic potential for immune escape and synergizes with anti-PD-1 treatment

Presenters: Juying Li, Qian Zhang, Bingqing Shen, Manan Shah, Mingjie Chen, Sharon Li, Ling Dong, Francisco Adrian, Liang Schweizer…Read more

Stage
Preclinical Development
Mechanism of Action
Immune Suppressive Pathways
Overview

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

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.

 

Related Announcement
FibroGen and HiFiBiO Announce Transformative Partnership to Advance Next-Generation Therapies for Patients with Cancer and Autoimmune Disease
FibroGen, Inc. (Nasdaq: FGEN) and HiFiBiO Therapeutics, a private, multinational clinical-stage biotherapeutics company with expertise in immune modulation and single cell science announced a partnership covering three HiFiBiO programs… Read more
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
Preclinical Development
Mechanism of Action
Cell Depleting
Overview

Immuno-oncology

 

Target

CCR8 is a GPCR with prevalent and highly specific expression on immunosuppressive tumor infiltrating regulatory T cells (Tregs) across different tumor types. Stimulation of CCR8 by its ligand results in proliferation of Tregs in the tumor microenvironment and immune-suppression. Targeting CCR8 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.

Antibody

HFB101110, a humanized monoclonal antibody against CCR8 with potent and specific antibody-dependent cellular cytotoxicity (ADCC) activity. HFB101110 specifically recognizes an epitope on the N-terminus extracellular domain of CCR8 and does not recognize the closely related chemokine receptor CCR4. HFB101110 acts through a dual mechanism of action, by both depleting CCR8+ cells via ADCC and blocking binding of the CCL1 chemokine to its receptor CCR8.

 

Related Announcement
FibroGen Exercises Exclusive License Option for HiFiBiO’s CCR8 Program
FibroGen, Inc. (Nasdaq: FGEN), a leading biopharmaceutical company discovering, developing, and commercializing first-in-class therapeutics, and HiFiBiO Therapeutics, a private, multinational clinical-stage biotherapeutics company with expertise in immune modulation and single cell science, today announced… 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

Related Article
HiFiBiO Therapeutics Announces Three Presentations at 2022 American Association for Cancer Research (AACR) Annual Meeting

We are excited to share with the oncology research community at AACR updates for two of our preclinical development programs – HFB200603, a novel anti-BTLA blocking antibody on track for IND submission, and HFB101110, an anti-CCR8 depleting antibody that was recently licensed to FibroGen…Read more

Related Article
Targeting regulatory T cells with HFB101110, a novel anti-human CCR8 antibody for the treatment of solid tumors

Presenters: Roshan Kumar, Julie Prigent, Hombline Poullain, Ayrin Kök, Carine George, Sami Ellouze, Yun-Yueh Lu, Rebecca Silver, Clarisse Monchecourt, Ross Fulton, Qian Zhang, Nicola Beltraminelli, Bernhard Moser, Francisco Adrian, Liang Schweizer…Read more

Stage
Preclinical Development
Mechanism of Action
Cell Depleting
Overview

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

 

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
Antibody Discovery
Mechanism of Action
Immune Suppressive Pathways
Overview

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. While blocking the BTLA interaction with HVEM could re-stimulate anti-tumor immunity in oncology, BTLA agonism has the potential to dampen the immune system in auto-immune diseases.

Antibody

HFB200604 was identified as a single-digit nanomolar binder to human and cynomolgus BTLA, capable of inhibiting the proliferation of primary human B cell and activation of T cells. HFB200604 exhibits favorable mouse PK and developability profiles and controls disease in a humanized mouse model of GvHD. We foresee applications for HFB200604 in multiple immune-mediated diseases.

 

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

We are exploring strategic partnerships for Enuzovimab (HFB30132A), a Delta variant active SARS-COV-2 neutralizing antibody with a completed Ph I healthy volunteer trial. Read more

Immune Stimulatory PathwaysCell DepletingImmune Suppressive Pathways

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 Intelligence Science (DIS™) single-cell capabilities
  • Collaborations with leading immunology and oncology key opinion leaders
  • Target deconvolution using patients’ antibody repertoires