HiFiBiO Therapeutics Company Profile

Background

HiFiBiO Therapeutics is a global clinical-stage biotechnology company dedicated to developing curative immunotherapies for patients with high unmet medical needs. The company leverages its proprietary Drug Intelligence Science (DIS®) platform to gain deep insights into immune modulation across various diseases, aiming to enhance the probability of success for immunotherapies from target discovery to patient treatment.

Key Strategic Focus

HiFiBiO Therapeutics focuses on:

Immuno-Oncology and Autoimmune Diseases: Developing innovative antibody therapeutics targeting both innate and adaptive immunity to treat cancer and autoimmune disorders.

DIS® Platform Utilization: Employing its unique DIS® platform, which combines single-cell capabilities with AI/ML approaches, to discover novel targets, effective antibody drugs, and predictive biomarkers.

Global Clinical Development: Advancing a robust pipeline of transformative immunotherapies through strategic collaborations and internal development programs.

Financials and Funding

HiFiBiO Therapeutics has secured significant funding to support its research and development initiatives:

Series D Financing (June 2021): Raised $75 million in an oversubscribed round led by Mirae Asset Financial Group, with participation from B Capital Group, Sherpa, and existing investors such as IDG and Sequoia Capital China. The funds are allocated to advance two lead antibody oncology assets into Phase I clinical trials and to further develop the DIS® platform.

Series B Financing (May 2018): Secured $37.5 million led by Sequoia China and LYFE Capital, supporting the company's transformation into a multinational biopharmaceutical enterprise and the advancement of its antibody drug pipeline.

Pipeline Development

HiFiBiO Therapeutics is advancing several key candidates:

HFB200301: A first-in-class anti-TNFR2 agonistic monoclonal antibody currently in Phase I clinical trials for advanced solid tumors, both as a monotherapy and in combination with tislelizumab, an anti-PD-1 immune checkpoint inhibitor.

HFB301001: A differentiated second-generation anti-OX-40 antibody being developed as a potential novel treatment for solid tumor indications.

HFB200603: A best-in-class BTLA antagonist currently in Phase I clinical trials for advanced solid tumors.

Technological Platform and Innovation

HiFiBiO Therapeutics' DIS® platform is a cornerstone of its innovation strategy:

Proprietary Technologies: The DIS® platform integrates single-cell profiling technologies with advanced AI/ML-based data analytics to gain unprecedented insights into human disease biology.

Scientific Methodologies: Utilizing microfluidic single-cell technology, the platform enables rapid discovery of novel antibody therapeutics with predictive biomarkers, enhancing the probability of clinical success.

Leadership Team

Liang Schweizer, PhD: Founder, Chairperson, and CEO. Dr. Schweizer brings over 30 years of experience in biomedical research and drug discovery, previously holding senior management roles at Sanofi and Bristol-Myers Squibb.

Jeff He: Chief Operating Officer. With more than 20 years in corporate finance, strategy, and operations, Mr. He was previously an Executive Vice President at ChemPartner.

Colin Brenan, PhD: Chief Commercial Officer. Dr. Brenan is one of the original founders of HiFiBiO Inc. and continues to serve in a leadership capacity.

Fred Dom: Chief Financial Officer. Mr. Dom, also an original founder, has assumed the role of CFO, contributing to the company's financial strategy.

Competitor Profile

Market Insights and Dynamics

The immunotherapy market is experiencing significant growth, driven by advancements in cancer treatment and autoimmune disease management. The global immunotherapy market is projected to reach substantial figures by 2025, with increasing investments in research and development.

Competitor Analysis

Key competitors in the immunotherapy space include:

Kite Pharma (a Gilead Company): Focuses on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies. Kite has collaborated with HiFiBiO to develop technology for the discovery of neoantigen-reactive TCRs.

Pfizer Inc.: Engages in antibody research collaborations, including a partnership with HiFiBiO to develop and validate high-throughput antibody discovery platforms.

Strategic Collaborations and Partnerships

HiFiBiO Therapeutics has established several significant collaborations:

Kite Pharma: Entered into a research collaboration to develop technology for the discovery of neoantigen-reactive TCRs for cancer treatment.

Pfizer Inc.: Achieved milestones in an antibody research collaboration focusing on high-throughput antibody discovery platforms.

Novartis: Entered a clinical trial supply agreement to evaluate HFB200301 in combination with tislelizumab in patients with advanced solid tumors.

Operational Insights

HiFiBiO Therapeutics differentiates itself through:

DIS® Platform: The integration of single-cell technologies with AI/ML analytics provides a competitive edge in target discovery and biomarker identification.

Global Presence: With operations across the USA, France, and China, the company leverages a diverse talent pool and market access.

Open Innovation Model: Collaborations with leading pharmaceutical companies and academic institutions enhance its research capabilities and pipeline development.