On September 5, 2022 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, reported that clinical trial investigator, Anthony B. El-Khoueiry, MD, Associate Director for Clinical Research and Phase I Program Director at the University of Southern California, Norris Comprehensive Cancer Center, and Associate Professor of Clinical Medicine at the Keck School of Medicine of USC, will present a Trials in Progress Poster for HFB301001 on Monday, September 12 from 12:00 to 13:00 CEST at the 2022 ESMO (Free ESMO Whitepaper) Congress held September 9 – 13, 2022, in Paris, France (Press release, HiFiBiO Therapeutics, SEP 5, 2022, View Source [SID1234618988]).
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"HFB301001 is positioned as a second generation anti-OX40 antibody that induces T cell activation and demonstrates anti-tumor activity in animal models compared to first-generation antibodies," said Anthony El-Khoueiry, MD. " USC Norris is excited to be part of this Phase I clinical study (NCT05229601), our second program working with HiFiBiO Therapeutics."
"We look forward to sharing the clinical study for HFB301001 in DIS selected indications including soft tissue sarcoma, renal cell carcinoma, hepatocellular carcinoma, and HNSCC," said Luigi Manenti, MD, Chief Medical Officer of HiFiBiO Therapeutics. "We believe HFB301001’s optimized pharmacological profile combined with our dosing strategy and with our DIS driven clinical development plan will allow us to differentiate from first generation anti-OX40 antibodies, and potentially make a difference for these patients."
Details on the poster presentation are as follows:
Title: Phase I study of HFB301001, a novel OX40 agonist monoclonal antibody, in patients with solid tumors selected via Drug Intelligence Science (DIS)
Poster Number: 783TiP
Poster Session: Investigational Immunotherapy
Location: Hall 4
Session Date and Time: Monday, September 12 9:00 – 17:00 CEST
The abstract can be viewed here. The full e-poster will be available on the virtual platform on Saturday, September 10 at 9:00 CEST.
HFB301001 (OX40)
HFB301001 is a novel fully human IgG1 class OX40 agonistic antibody with an optimized pharmacological profile. In contrast to other anti-OX40 antibodies, the agonistic activity of HFB301001 is further enhanced in the presence of the endogenous ligand OX40L and does not result in reduced expression of OX40 on T cells. HFB301001 demonstrated enhanced anti-tumor activity in a human OX40 knock-in mouse model compared to a competitor antibody and is positioned as a best-in-class differentiated molecule for enhanced clinical activity. HiFiBiO is applying a biomarker strategy by leveraging its DIS platform to select indications and patients who may benefit the most from HFB301001 treatment.