SAN DIEGO, Feb. 10, 2026 (GLOBE NEWSWIRE) -- A demonstrated 100% concordance between biomarker-guided predictions from pre-treatment patient samples and clinical outcomes validates Yatiri Bio’s platform as a breakthrough in oncology patient stratification.
Yatiri Bio, a precision medicine company utilizing an AI-driven proteomic platform (ProteoCharts™) to identify therapeutically sensitive patient populations, reports results from a blinded retrospective clinical validation study evaluating Foghorn Therapeutics’ FHD-286 (camibirstat) in patients with relapsed or refractory acute myeloid leukemia (R/R AML) or myelodysplastic syndrome (MDS). FHD-286 is a novel, potent, and selective inhibitor of the ATPase subunits of the BAF complex, SMARCA4 and SMARCA2. Inhibition of this complex has demonstrated cytotoxic activity in selected AML cell lines in preclinical models and has been associated with clinical responses in an R/R AML and MDS Phase 1 trial.
Yatiri Bio’s AML ProteoCharts™ is a molecularly defined disease landscape that integrates unbiased proteomic profiles from AML patient samples with associated clinical metadata, and drug testing on proprietary patient-derived cellular models with proteomic profiles of the drug-perturbed systems. These patient-derived cellular models capture patient heterogeneity beyond other commercially available cell lines which allows for highly refined patient clusters. Using deep neural networks, an AML model was developed and evaluated with FHD-286. This approach identified a distinct set of biomarkers for FHD-286 that accurately stratify patients according to therapeutic sensitivity.
In this study, Foghorn Therapeutics provided eight blinded pre-treatment peripheral blood mononuclear cell (PBMC) samples from patients with relapsed or refractory AML or myelodysplastic syndrome (MDS) enrolled in a Phase 1 trial (ClinicalTrials.gov identifier: NCT04891757). Analysis of these blinded samples demonstrated 100% concordance between ProteoCharts™ predictions and observed clinical responses, supporting the reliability of the platform for patient stratification and its potential to inform targeted clinical development.
Yatiri Bio correctly identified patients who achieved complete or partial responses (CR/PR) and accurately classified patients who experienced stable disease or treatment failure. All predictions were generated exclusively from pre-dose peripheral blood samples, without access to additional patient information, including mutational status, dosing, trial arm assignment, or clinical outcomes. Yatiri Bio’s results suggest that patient selection based on predictive biomarkers could have significantly altered the observed response rate.
“Our mission is to match the right patients to the right therapies before clinical trials begin,” said Dr. Jackson. “As the biotech industry becomes more capital disciplined, eliminating clinical ambiguity through more precise patient stratification is not optional, it is essential.”
As a result of this work, Yatiri Bio and Foghorn Therapeutics have now signed a collaboration agreement for Foghorn to supply material for the further clinical development of FHD-286. Utilizing Yatiri Bio’s biomarkers may enable identification of sensitive patients before treatment and help those patients suffering from R/R AML or MDS. The terms of the agreement include clinical, and sales milestones valued at >$40M.
About Yatiri Bio
Yatiri Bio is a precision medicine company focused on the identification and validation of biomarkers that predict therapeutic responses in oncology. The company develops predictive assays to stratify patients prior to treatment, with the goal of improving clinical trial success rates and accelerating the development of effective therapies. Yatiri Bio is already advancing partnerships with biopharmaceutical companies seeking to de-risk clinical development by integrating biomarker-based patient selection into early-stage trials. The company plans to expand its ProteoCharts™ across hematologic and solid tumors in 2026, including MDS, ovarian cancer, prostate, breast, and CRC. Pharmaceutical companies interested in a collaboration in these or other indications should reach out to info@yatiribio.com for more information.
