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HiFiBiO Therapeutics to Present Phase 1 Clinical Trial Data for Two Novel Immuno-Oncology Agonists at the 2024 Annual Meeting of the American Society of Clinical Oncology

CAMBRIDGE, MA – May 24, 2024 – HiFiBiO Therapeutics, an innovative clinical stage biotechnology company committed to improving patient lives with single cell precision, today announced its participation in the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO), set for May 31-June 4, 2024, in Chicago, IL.  

 

The company will present Phase 1 trial data on two novel agonists: the first-in-class TNFR2 agonist HFB200301 (NCT05238883) and the next-generation OX40 agonist HFB301001 (NCT05229601). These agonists were developed using HiFiBiO’s innovative Drug Intelligence Science (DIS®) platform, which incorporates microfluidic single-cell technology and advanced AI/ML data analysis to assess patient tumor samples. The aim is to select optimal tumor types and predictive biomarkers to enhance the probability of clinical success. Insights gained from these Phase 1 trials will guide the recommended dosages and patient stratification strategy for Phase 2. 

 

In addition to advancing Dose Expansion studies for each of the agonists, the company is also advancing a third clinical program, the best-in-class BTLA antagonist HFB200603 (NCT05789069). 

  

HiFiBiO’s novel immunotherapies and robust translational strategy demonstrate the company’s deep commitment to innovative research and its development of impactful therapies to address unmet medical needs. 

  

Details on the poster presentations are as follows: 

 

Title: Phase I dose escalation trial of the first-in-class TNFR2 agonist monoclonal antibody, HFB200301, in monotherapy and in combination with tislelizumab, an anti-PD-1 monoclonal antibody, in adult patients with advanced solid tumors 

Abstract Number: 2526 

Session Date and Time: 6/1/2024. 9 – 12 pm CDT  

Presenter: Desamparados Roda, MD, PhD, Hospital Clínico Universitario de Valencia 

View the full abstract here.

 

Title: A phase I monotherapy dose escalation study of HFB301001, a novel next generation OX40 agonist monoclonal antibody, in adult patients with advanced solid tumors 

Abstract Number: 2531 

Session Date and Time: 6/1/2024. 9 – 12 pm CDT  

Presenter: Anthony El-Khoueiry, MD, University of Southern California Norris Comprehensive Cancer Center 

View the full abstract here.

 

The posters will be available on the HiFiBiO Therapeutics website shortly after the live presentation.  

 

About HFB200301

HFB200301 is a first-in-class, agonistic monoclonal antibody targeting TNFR2. It is designed to stimulate both innate and adaptive immune responses. The stimulation of T-cells and NK-cells within the tumor microenvironment is expected to enhance anti-tumor immunity effectively. To enhance the probability of clinical success, HiFiBiO Therapeutics is leveraging its DIS® platform to select tumor types most likely to respond to HFB200301, based on target biology and single-cell insights from patient-derived tumors, including refractory tumors.

About HFB301001

HFB301001 is a next-generation, agonistic monoclonal antibody targeting OX40. Prior OX40 agonist antibodies have demonstrated promising preclinical activity but had limited clinical impact, likely due to their pharmacological properties. HFB301001 overcomes these limitations by binding to a unique, non-competing epitope, thus preserving the OX40/OX40L interaction. Moreover, HFB301001 does not decrease OX40 surface levels upon co-stimulation. To enhance the probability of clinical success, HiFiBiO Therapeutics is leveraging its DIS® platform to select tumor types most likely to respond to HFB301001, based on target biology and single-cell insights from patient-derived tumors, including refractory tumors.

About HiFiBiO Therapeutics 

HiFiBiO Therapeutics is a clinical-stage US biotech with a global footprint 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 

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