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HiFiBio Therapeutics Launches AI-Guided Trial in Advanced Solid Tumors

NEW YORK – HiFiBio Therapeutics on Friday said it began a Phase Ia/Ib study of its agonistic anti-TNFR2 antibody HFB200301 using the drug intelligence science (DIS) platform to gauge treatment benefit and select tumor indications most likely to benefit from the drug.

Indications selected by HiFiBio's DIS platform are based on a mechanistic signature enriched in certain cancer types. The platform combines single-cell microfluidics with machine learning to analyze bulk transcriptional data and data from HiFiBio's single-cell database covering 18 tumor types and eight autoimmune diseases. 

In the Phase Ia/Ib trial, HiFiBio researchers will evaluate the safety and tolerability of HFB200301 alone and in combination with Novartis' anti-PD-1 antibody tislelizumab in patients with advanced cancers. In the first part of the study, participants will receive increasing doses of HFB200301 with or without tislelizumab until a safe and tolerable dose is found. In the second part of the trial, patients will be assigned to a group based on the type of cancer they have and will receive HFB200301 alone or with tislelizumab at the dosage determined in the first part of the trial.

According to the company, the study includes a comprehensive biomarker plan encompassing phenotypic and genotypic readouts from bulk and single-cell analysis of blood and tumor samples collected prior to and during treatment. A biomarker signature will be used to assess correlates of clinical activity, guide selection of a recommended dose, and identify indications for expansion.