Business Fortune
Clinical-stage biotechnology is crucial to converting scientific findings into secure and efficient medical interventions. It guarantees that before new treatments are administered to patients, they must pass stringent human studies to confirm their safety, effectiveness, and dose. Without it, there might be significant dangers associated with experimental medicines, which would impede medical breakthroughs and leave many diseases without cures.
Ignoring this step would also have moral and financial repercussions, including resource waste, unsuccessful therapies, and a decline in public confidence. By guaranteeing that only the safest and most effective treatments make it to market, clinical-stage biotech protects healthcare. HiFiBiO Therapeutics fills this gap by developing a biotech that leads the industry in providing revolutionary immunotherapies.
Creating Therapeutic Immunotherapies for Patients
Curative immunotherapies for patients with significant unmet medical needs are being pioneered by HiFiBiO Therapeutics. With its proprietary Drug Intelligence Science (DIS®) platform, the business is focusing on the underlying causes of illness. DIS® uses AI/ML analytics and unique single cell technologies to provide a comprehensive knowledge of cellular pathology across a range of disorders. To improve patient clinical outcomes, this platform is being used in target discovery, antibody selection, and predictive biomarker identification.
HiFiBiO was founded in 2017 with the intention of using state-of-the-art single cell technology and deep immune modulation knowledge to provide patients with life-changing medications. Their plan is to increase the clinical likelihood of success by utilizing DIS®, a revolutionary single-cell translational platform, to develop a pipeline of ground-breaking immunotherapies.
Platform-Services for DIS ®
To improve success from target to patient, HiFiBiO's Drug Intelligence Science (DIS®) platform combines cutting-edge single-cell technology with AI/ML analysis. Their DIS®-powered methodology advances innovative immunomodulatory treatments by producing deep insights into the biology of illness. In order to increase success rates and reduce turnaround times, HiFiBiO uses DIS® at every step of drug research and development.
Clinical
To create data-driven predictive biomarker hypotheses, extensive information is gathered and examined from imaging, sequencing, PK/PD analysis, and patient history. Finding predictive biomarkers to prospectively select patients for improved clinical response is made possible by the insights this approach produces.
Preclinical
To guide the selection of indications and enable more effective and efficient clinical trials, a great deal of ex-vivo and computational analysis of patient samples is carried out in order to obtain insights into disease biology.
Discovery
Target Discovery: To find pertinent targets implicated in illnesses with significant medical demand, patient samples and data are analyzed experimentally and computationally. DIS® offers a high-resolution perspective at the cellular level for identifying targets that are solely linked to illness.
Antibody Discovery: Powered by bioinformatics software (AbSolutionTM) for data analysis of individual B cells, HiFiBiO's DIS® driven antibody discovery platform enables the screening of millions of species-agnostic B cells in a matter of hours (CelliGoTM). To increase their degree of efficiency and get better results, their machine learning model directs antibody binding prediction and affinity maturation. Consequently, they have developed a cutting-edge antibody discovery platform with a remarkable success rate and shorter turnaround times.
Pipeline
In order to treat cancer and immunology and inflammation diseases (I&I), HiFiBiO is creating next-generation immunotherapies. Their sustainable pipeline of immunomodulatory antibodies targets various cell types and important immunosuppressive or inflammatory mechanisms.
First-in-class TNFR2 agonist monoclonal antibody emunkitug (HFB200301, NCT05238883), next-generation fully human OX40 agonist monoclonal antibody nuvustotug (HFB301001, NCT05229601), and best-in-class BTLA antagonist monoclonal antibody HFB200603 (NCT05789069) are the three Phase 1 clinical programs that HiFiBiO currently has underway. Dose escalation has been accomplished satisfactorily in all three programs.
Numerous initiatives in their preclinical pipeline target important immune cell types implicated in I&I. The most sophisticated, HFB200604 is an IND-clearing best-in-class BTLA agonist antibody.
Liang Schweizer, | Founder, Board Chair and CEO
Liang Schweizer is the Founder, Board Chair, and CEO of HiFiBiO Therapeutics, bringing over 30 years of research and industry experience. In addition to co-inventing 12 immuno-modulatory therapeutic antibodies with more than 50 patent publications, she has produced several articles and given keynote addresses all over the world. She has contributed to more than 30 clinical candidates and five commercialized medications. She received the EY Entrepreneur of the Year New England award in 2024, and in 2023, HiFiBiO Therapeutics was awarded a Fierce 15 Biotech.
Prior to HiFiBiO, Liang was a co-founder of Harbour Biomed, where he served as CSO and turned the company from a technological platform into an antibody drug discovery company. She formerly oversaw Asian Cancer Research at Sanofi, where she advanced Asia-Pacific cancer pipelines and supported international initiatives from preclinical to clinical phases. She was a director at Bristol-Myers Squibb as well.
Liang has an M.S. in Microbial Engineering and Chemical Engineering from the University of Minnesota and a B.S. from the University of Science and Technology of China (USTC). After graduating from the University of Zurich with a Ph.D. in Molecular Biology, she worked as a postdoc at Memorial Sloan Kettering Cancer Center under Nobel Laureate Dr. Harold Varmus.
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