Top 5 Target	Count

CCR8(C-C motif chemokine receptor 8)	1
CXCR5(C-X-C motif chemokine receptor 5)	1
BTLA(B- and T-lymphocyte attenuator)	1
TNFR2(Tumor necrosis factor receptor superfamily member 1B)	1
OX40(Tumor necrosis factor receptor superfamily member 4)	1

Drugs associated with Hifibio SAS

Nuvustotug

Target

OX40

Mechanism

OX40 agonists

Active Org.

Hifibio SAS

Originator Org.

Hifibio SAS

Active Indication

Advanced Malignant Solid Neoplasm [+6]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Emunkitug

Target

TNFR2

Mechanism

TNFR2 agonists

Active Org.

HiFiBiO Therapeutics (Hangzhou) Co., Ltd. [+2]

Originator Org.

Hifibio SAS

Active Indication

Advanced Malignant Solid Neoplasm [+9]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

HFB-200603

Target

BTLA

Mechanism

BTLA blockers

Active Org.

HiFiBiO Therapeutics (Hangzhou) Co., Ltd. [+1]

Originator Org.

Hifibio SAS

Active Indication

Advanced Malignant Solid Neoplasm [+6]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Hifibio SAS

CTR20240240

/ Not yet recruitingPhase 1

一项HFB200301（TNFR2激动剂抗体）单药治疗以及与替雷利珠单抗（抗PD-1抗体）联合用药治疗成人晚期实体瘤患者的Ia/Ib期、开放性、多中心、剂量递增和剂量扩展研究

[Translation] A Phase Ia/Ib, open-label, multicenter, dose-escalation and dose-expansion study of HFB200301 (TNFR2 agonist antibody) as monotherapy and in combination with tislelizumab (anti-PD-1 antibody) in adult patients with advanced solid tumors

主要目的：表征HFB200301单药的安全性和耐受性，并确定RDE(s)和RP2D(s)。次要目的：评估HFB200301的PK、PD，确定生物活性剂、免疫原性和初步抗肿瘤疗效。

[Translation]

Primary objective: To characterize the safety and tolerability of HFB200301 monotherapy and determine the RDE(s) and RP2D(s). Secondary objectives: To evaluate the PK, PD, bioavailability, immunogenicity and preliminary anti-tumor efficacy of HFB200301.

Start Date-

Sponsor / Collaborator

Pierre Fabre Participations SAS

[+2]

NCT05229601

/ Active, not recruitingPhase 1

A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients With Advanced Solid Tumors

The purpose of this study is to test the safety and tolerability of HFB301001 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable doses of HFB301001 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer they have.

Start Date20 Apr 2022

Sponsor / Collaborator

Hifibio SAS

100 Clinical Results associated with Hifibio SAS

0 Patents (Medical) associated with Hifibio SAS

Literatures (Medical) associated with Hifibio SAS

01 Jun 2022·Journal of Clinical Oncology

Phase I study of HFB200301, a first-in-class TNFR2 agonist monoclonal antibody in patients with solid tumors selected via Drug Intelligent Science (DIS).

Author: Zugazagoitia, Jon ; Spira, Alexander I. ; Manenti, Luigi ; Hatzis, Christos ; El-Khoueiry, Anthony B. ; Babiker, Hani M. ; Garralda, Elena ; Adrian, Francisco ; Raue, Andreas ; Leventakos, Konstantinos ; Gan, Jinping ; Chen, Margaret ; Oppelt, Peter John ; Roda, Desamparados ; Borad, Mitesh J. ; Naing, Aung

TPS2670 Background: Tumor necrosis factor receptor-2 (TNFR2) is expressed on effector CD8+ T cells, CD4+ T cells, T regulatory cells, natural killer cells, and myeloid cells. Targeting TNFR2 is anticipated to yield effective anti-tumor immunity by stimulating T-cell and NK-cell activation and proliferation in the tumor microenvironment. HFB200301 is a first-in-class anti-TNFR2 agonistic monoclonal antibody that triggers both innate and adaptive immune stimulation by binding to a specific epitope on TNFR2. HFB200301 has demonstrated dose-dependent anti-tumor activity in human TNFR2 knock-in mice bearing MC38 and Hepa1-6 syngeneic tumors. Methods: HFB200301 is being evaluated in a first-in-human, open-label, multi-center, dose escalation and expansion study in adult patients with advanced solid tumors. A single-cell immune profiling platform, DIS, was deployed to identify unique tumor-infiltrating T cell signatures that could help optimize patient selection for HFB200301 treatment. It is hypothesized that the presence of an effector T cell subpopulation that express both TNFR2 and CD8A in solid tumors may represent a tumor microenvironment favorable to TNFR2 agonism. The following cancer indications have been identified based on the prevalence of a TNFR2 high/CD8 high signature: Epstein-Barr Virus positive (EBV+) gastric cancer, clear cell renal cell carcinoma (ccRCC), cutaneous melanoma, testicular germ cell tumor (TGCT), soft tissue sarcoma (STS), and PD-L1+ cancers: cervical cancer, pleural mesothelioma, lung adenocarcinoma, and head and neck squamous cell carcinoma (HNSCC). The escalation portion of the study explores increasing doses in cohorts of up to six patients, utilizing mTPI-2 design to determine recommended dose(s) for expansion (RDE(s)). Based on pharmacokinetic modeling to maximize HFB200301 activity, 60-minute intravenous infusions of HFB200301 are administered every 4 weeks. Once RDE(s) is determined, expansion into three indication-specific cohorts is planned to determine the recommended phase 2 dose (RP2D). Key eligibility criteria include histologically documented advanced or metastatic solid tumors in the above listed indications. Patient enrollment opened in February 2022 in the USA, with plans for additional clinical sites in Spain and China. The primary objective is to identify the RDE, characterize safety and tolerability of HFB200301, and determine RP2D. Secondary objectives include pharmacokinetic parameters, preliminary evidence of anti-tumor efficacy (e.g., ORR, DCR, DOR) and pharmacodynamic evaluation (e.g., T cell subsets) in the blood and in the tumor. Furthermore, a potential predictive biomarker signature derived based on the DIS single-cell immune profiling approach will be investigated retrospectively. Clinical trial information: NCT05238883.

22 Oct 2021·ScienceQ1 · CROSS-FIELD

Defining variant-resistant epitopes targeted by SARS-CoV-2 antibodies: A global consortium study

Q1 · CROSS-FIELD

Article

Author: Rikhtegaran Tehrani, Zahra ; Yu, Jian ; Zandonatti, Michelle ; Hariharan, Chitra ; Federman, Ross S. ; MacCamy, Anna ; Aracic, Sanja ; Olmedillas, Eduardo ; Tomic, Milan T. ; Snitselaar, Jonne L. ; Krebs, Shelly J. ; Liu, Junli ; Zhang, Qian ; Enriquez, Adrian ; Ho, David D. ; Sajadi, Mohammad M. ; Fernandez, Joseph M. ; Sato, Aaron K. ; Grigoryan, Gevorg ; Dennison, S. Moses ; Yuan, Tom Z. ; Kim, Hyeong Mi ; van Gils, Marit J. ; Schweizer, Liang ; Rabbitts, Terence H. ; Jiang, Weidong ; Kong, Chao ; Parekh, Diptiben ; Leung, Cheuk Lun ; Lang, Guojun ; Kim, Cheolmin ; Schendel, Sharon L. ; Buck, Tierra ; Stamatatos, Leonidas ; Li, Haoyang ; Youssef, Sawsan ; Ingraham, John ; Hastie, Kathryn M. ; Sanders, Rogier W. ; Yin, Jieyun ; Diaz Avalos, Ruben ; Lujan Hernandez, Ana G. ; Lee, Sooyoung ; Aldon, Yoann ; Feeney, Elizabeth ; Kim, Minsoo ; Shaffer, Kelly ; McGuire, Andrew T. ; Kellam, Paul ; Li, Kan ; Saphire, Erica Ollmann ; Glanville, Jacob ; Abraha, Milite ; Tan, Yongcong ; Bedinger, Daniel ; Cobb, Ronald R. ; Hui, Sean ; Ali, Hanif ; Shen, Bingqing ; Palser, Anne L. ; Tomaras, Georgia D. ; Zyla, Dawid ; Lan, Fei ; Seo, Jimin ; Lu, Yanan ; Peters, Bjoern ; Germann, Timothy ; Rayaprolu, Vamseedhar ; Yu, Xiaoying ; Green, Robin ; Mann, Colin ; Horn, Gillian Q. ; Huang, Kuan-Ying A.

Community of antibodies against COVID-19 The severe acute respiratory syndrome coronavirus 2 spike protein is the basis of many vaccines and is a primary target of neutralizing antibodies after COVID-19 infection. The Coronavirus Immunotherapeutic Consortium (CoVIC), comprising 56 partners across the world, has analyzed a panel of 269 monoclonal antibodies (mAbs) and, on the basis of competition profiles, sorted 186 mAbs that target the receptor binding domain into seven communities. Hastie et al . went on to structurally analyze representative antibody binding and used pseudovirus neutralization assays to study the effect of spike mutations on antibody function, including the combinations of mutations found in certain variants of concern. These results are important to guide both treatment and prevention efforts. —VV

15 Aug 2020·Cancer Research

Abstract 2282: Discovery and characterization of novel TNFR2 antibodies to modulate T cell activities in immunosuppressive environment

Author: Rose, Greg ; Beq, Stephanie ; Ortega, Charina ; Schweizer, Liang ; Kumar, Roshan ; Adrian, Francisco ; Mary, Pascaline ; Zhou, He ; Beltraminelli, Nicola ; Zhang, Qian ; Li, Juying ; Yang, Guang ; Delince, Matthieu ; Wei, Shuo ; Lee, Dean

AbstractTNFR2 has recently emerged as a promising therapeutic target for Immuno-Oncology. TNFR2 expression on regulatory and effector T cells in the tumor microenvironment has been associated with T cell exhaustion and resistance to immune-checkpoint blockade. In light of this, we set out to discover antibodies against human TNFR2 that could be developed as anti-cancer agents. Mouse immunization with the recombinant extracellular domain of human TNFR2 and subsequent single B cell screening using our proprietary microfluidic-based single cell platform, CelliGO™, identified a series of diverse antibodies that were characterized for binding, cross-reactivity, selectivity and functional activity. Two antibodies, HFB3-1 and HFB3-14, with sub- or single-digit-nanomolar binding affinities for human TNFR2 were selected for further characterization and humanization. Epitope mapping experiments show that the two antibodies recognize different domains of TNFR2: HFB3-1 binds to a region within the CRD2 domain and HFB3-14 binds within the CRD3 region. Despite their different binding sites, both antibodies are selective for TNFR2, cross-react with cynomolgus and rhesus monkey orthologs, and enhance the binding of human recombinant TNFα to TNFR2, as well as stimulate CD8 and conventional CD4 T cells. Humanized variants of these antibodies, HFB3-1hz6 and HFB3-14hz1c, retaining the binding and cross-reactivity profiles of the parent antibodies, were assessed for their functional activities, developability and pharmacokinetic profiles. The humanized antibodies preferentially bind to TCR-activated primary CD8 and CD4 T cells as compared to unstimulated T cells and enhance CD3/CD28-induced activation and proliferation. This co-stimulatory mechanism of action is cross-linking independent and is consistent with the antibodies' ability to enhance NFκB signaling and induce upregulation of NFκB downstream target genes. Both antibodies demonstrated good developability profile and stability under high temperature, low pH conditions and following several freeze/thaw cycles. Good plasma exposures for lead antibodies were observed in mice models. The in vivo efficacy evaluation of both antibodies in mouse tumor models as well as initial toxicology analysis are in progress. The functional profile of these antibodies along with their favorable developability and pharmacokinetic profiles support their development as a potential novel immune-therapeutic option for cancer patients.Citation Format: Shuo Wei, Guang Yang, Juying Li, Qian Zhang, Matthieu Delince, Greg Rose, Charina Ortega, Pascaline Mary, He Zhou, Dean Lee, Roshan Kumar, Stephanie Beq, Nicola Beltraminelli, Francisco Adrian, Liang Schweizer. Discovery and characterization of novel TNFR2 antibodies to modulate T cell activities in immunosuppressive environment [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 2282.

News (Medical) associated with Hifibio SAS

04 Nov 2024

·pipelinereview.com

HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200604, a Best-in-Class BTLA Agonist Antibody for the Treatment of Inflammatory and Immunology Diseases

CAMBRIDGE, MA, USA I November 04, 2024 I HiFiBiO Therapeutics, a clinical stage biotechnology company focused on immune modulation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for HFB200604 . HFB200604 is a best-in-class BTLA agonist monoclonal antibody, developed using HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform. The therapy is designed to restore immune tolerance in inflammatory and immunology diseases by stimulating BTLA signaling in immune cells. “HFB200604 represents our first autoimmune program to advance into clinical development, highlighting HiFiBiO’s innovative approach to rapidly translating patient insights into impactful therapies,” said Liang Schweizer, Ph.D., Founder, Chairperson, and CEO of HiFiBiO Therapeutics, “We are excited to leverage our DIS® platform to address the challenges of patient heterogeneity in inflammatory and immunology diseases, with the aim of achieving higher response rates.” Francisco Adrian, Ph.D., CSO of HiFiBiO Therapeutics, added “We are thrilled to bring our best-in-class BTLA agonist HFB200604 to patients suffering from inflammatory and immunology diseases. Our single-cell immune profiling data suggest that BTLA agonism could be a highly effective approach to reducing immune activation, and we look forward to translating compelling preclinical findings into meaningful clinical outcomes.” HiFiBiO plans to begin a single ascending dose (SAD) Phase 1 clinical study in a healthy volunteer cohort, followed by a multiple ascending dose (MAD) study in patients with selected inflammatory and immunology diseases identified through the HiFiBiO DIS® platform. HFB200604 HFB200604 is a best-in-class BTLA agonist monoclonal antibody designed to suppress activated T and B cells. Preclinical studies have shown that HFB200604 effectively inhibits T and B cell activation and demonstrated in vivo activities in a mouse model. About HiFiBiO Therapeutics HiFiBiO Therapeutics is a clinical-stage biotech driving a robust clinical pipeline of transformative immunotherapies targeting cancer and autoimmune diseases. HiFiBiO achieves an unprecedented understanding of immune modulation in human diseases by pioneering a unique high-resolution translational platform, Drug Intelligence Science (DIS®), which combines unique single-cell capabilities with AI/ML approaches. Using patient samples, DIS® enables the discovery of novel targets, effective antibody drugs, and predictive biomarkers to enhance the probability of success for immunotherapies. Moreover, HiFiBiO has established partnerships with major multinational pharmaceutical and biotech companies and has been recognized as one of the 2023 Fierce 15 biotech companies. For additional information, please visit www.hifibio.com SOURCE: HiFiBiO Therapeutics

ImmunotherapyINDPhase 1

07 Oct 2024

·hifibio.com

HiFiBiO Therapeutics to Showcase DIS® Enabled Translational Insights from Ongoing Phase 1 Clinical Trials for Two Novel Immuno-Oncology Antibodies at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

CAMBRIDGE, MA – October 7, 2024 – HiFiBiO Therapeutics, a clinical stage immune modulation biotechnology company today announced its participation in the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place November 6-10 in Houston, Texas. The company will present a pioneering clinical development strategy, showcasing the predictive power of its Drug Intelligence Science (DIS®) platform to guide the Phase I development of two novel monoclonal antibodies: a first-in-class TNFR2 agonist HFB200301 (NCT05238883) and a best-in-class BTLA antagonist HFB200603 (NCT05789069). DIS® provides a single cell and AI/ML-driven approach to selecting the most promising tumor types, dose regimen, and patient population for clinical success. HiFiBiO’s unique DIS® approach enables the translation of complex clinical data including patient history, imaging, PK/PD, and genomic sequencing into meaningful patient selection strategies for enhanced clinical benefit. This patient-data guided translational strategy demonstrates the company’s deep commitment to innovative research and impactful therapies to address the highest unmet medical needs. Details on the poster presentations are as follows: Title: Predictive and Generative AI to guide the clinical development of HFB200301, a first-in-class TNFR2 agonist: Drug Intelligence Science (DIS®). Abstract Number: 1233 Session Date: Friday, 8 November 2024 Speaker: Spencer Huggett, PhD, HiFiBiO Inc. Title: Utilizing Drug Intelligence Science (DIS®) for tumor type selection and molecular characterization of HFB200603, a best-in-class B and T Lymphocyte Attenuator (BTLA) monoclonal antagonist. Abstract Number: 1224 Session Date: Saturday, 9 November 2024 Speaker: Spencer Huggett, PhD, HiFiBiO Inc. The initial data from these abstracts will be available on the SITC website starting on November 5 at 9 am EST. Additionally, the posters will be accessible on the HiFiBiO Therapeutics website following the live presentation. About HiFiBiO Therapeutics HiFiBiO Therapeutics is a clinical-stage biotech driving a robust clinical pipeline of transformative immunotherapies targeting cancer and autoimmune diseases. HiFiBiO achieves an unprecedented understanding of immune modulation in human diseases by pioneering a unique high-resolution translational platform, Drug Intelligence Science (DIS®), which combines unique single-cell capabilities with AI/ML approaches. Using patient samples, DIS® enables the discovery of novel targets, effective antibody drugs, and predictive biomarkers to enhance the probability of success for immunotherapies. Moreover, HiFiBiO has established partnerships with major multinational pharmaceutical and biotech companies and has been recognized as one of the 2023 Fierce 15 biotech companies. For additional information, please visit www.hifibio.com HiFiBiO® is a trademark of HiFiBiO Therapeutics and its affiliates

ImmunotherapyAACRPhase 1

14 Sep 2024

·hifibio.com

HiFiBiO Therapeutics to Present Phase 1 Clinical Trial Data for Two Novel Immuno-Oncology Antibodies at the 2024 Annual Congress of the European Society for Medical Oncology

CAMBRIDGE, MA – August 22, 2024 – HiFiBiO Therapeutics, a clinical stage immune modulation biotechnology company today announced its participation in the 2024 Annual Congress of the European Society for Medical Oncology (ESMO), taking place September 13-17 in Barcelona, Spain. The company will present compelling Phase 1 trial data on two novel monoclonal antibodies: the first-in-class TNFR2 agonist HFB200301 (NCT05238883) and the best-in-class BTLA antagonist HFB200603 (NCT05789069). These programs have shown promise both as monotherapy and in combination with anti-PD-1, demonstrating the capability to elicit a robust anti-cancer immune response, even in IO refractory tumors. Harnessing its innovative Drug Intelligence Science (DIS®) platform, HiFiBiO is at the forefront of advancing these therapies by specifically selecting tumor types, optimizing dosing regimens, and identifying predictive biomarkers to increase the probability of clinical success. The insights gained from these Phase 1 trials will play a critical role in guiding Phase 2 dosing strategies and patient selection criteria. HiFiBiO’s novel immunotherapies and comprehensive translational strategy demonstrate the company’s deep commitment to innovative research and developing impactful therapies to address unmet medical needs. HiFiBiO is now applying this strategy to inflammation and immunology, with plans to submit an IND application for a novel BTLA agonist by the end of September. Details on the poster presentations are as follows: Title: Model-informed dose optimization of HFB200301, a TNFR2 agonist monoclonal antibody (mAb), in monotherapy and in combination with the anti-PD-1 mAb tislelizumab (TIS), in patients (pts) with advanced solid tumors. Presentation Number: 1011P Session Date: Saturday, 14 September 2024 Speaker: Desamparados Roda Perez, MD, PhD, Hospital Clínico Universitario de Valencia View the poster here. Title: Phase I dose escalation study of HFB200603, a best-in-class BTLA antagonist monoclonal antibody (mAb), in monotherapy and in combination with the anti-PD-1 mAb Tislelizumab (TIS) in adult patients (pts) with advanced solid tumors. Presentation Number: 1006P Session Date: Saturday, 14 September 2024 Speaker: María de Miguel, MD, PhD, MBA, START Madrid – CIOCC HM Sanchinarro View the poster here. The initial data from these abstracts will be available on the ESMO website starting on September 9 at 0:05 CEST. Additionally, the posters will be accessible on the HiFiBiO Therapeutics website following the live presentation. About HiFiBiO Therapeutics HiFiBiO Therapeutics is a clinical-stage biotech driving a robust clinical pipeline of transformative immunotherapies targeting cancer and autoimmune diseases. HiFiBiO achieves an unprecedented understanding of immune modulation in human diseases by pioneering a unique high-resolution translational platform, Drug Intelligence Science (DIS®), which combines unique single-cell capabilities with AI/ML approaches. Using patient samples, DIS® enables the discovery of novel targets, effective antibody drugs, and predictive biomarkers to enhance the probability of success for immunotherapies. Moreover, HiFiBiO has established partnerships with major multinational pharmaceutical and biotech companies and has been recognized as one of the 2023 Fierce 15 biotech companies. For additional information, please visit www.hifibio.com HiFiBiO® is a trademark of HiFiBiO Therapeutics and its affiliates

ImmunotherapyPhase 1ASCO

100 Deals associated with Hifibio SAS

100 Translational Medicine associated with Hifibio SAS

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Pipeline

Pipeline Snapshot as of 08 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 1 Clinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Nuvustotug ( OX40 )	Renal Cell Carcinoma More	Phase 1
Emunkitug ( TNFR2 )	Advanced Malignant Solid Neoplasm More	Phase 1
HFB-200902 ( galectin-9 )	Bone Marrow Neoplasms More	Preclinical
HFB-3024 ( KLRG1 )	Inflammation More	Preclinical
HFB-101110 ( CCR8 )	Solid tumor More	Preclinical

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