On August 22, 2024 HiFiBiO Therapeutics, a clinical stage immune modulation biotechnology company reported its participation in the 2024 Annual Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), taking place September 13-17 in Barcelona, Spain (Press release, HiFiBiO Therapeutics, AUG 22, 2024, View Source [SID1234646058]).
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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
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
The initial data from these abstracts will be available on the ESMO (Free ESMO Whitepaper) website starting on September 9 at 0:05 CEST. Additionally, the posters will be accessible on the HiFiBiO Therapeutics website following the live presentation.