On April 30, 2024 HiFiBiO Therapeutics, an innovative clinical stage biotechnology company committed to improving patient lives with single cell precision, reported its participation in the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), set for May 31-June 4, 2024, in Chicago, IL (Press release, HiFiBiO Therapeutics, APR 30, 2024, View Source [SID1234642461]).
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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
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
Abstracts highlighting initial data will be available at meetings.asco.org/abstracts-presentations on May 23 at 5:00 PM ET. The posters will be available on the HiFiBiO Therapeutics website shortly after the live presentation.