HFB200603 / HiFiBiO - LARVOL DELTA

HFB-200603-01: A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=83 | Active, not recruiting | Sponsor: HiFiBiO Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Gastric Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • BRAF

Evaluation of HVEM and PD-L1 expression profile in tumors as potential predictive biomarkers for HFB200603, a BTLA antagonist, as monotherapy and in combination with tislelizumab (ESMO 2025) - P1 | "MSS-CRC pts with PD-L1 CPS ≥ 10 (n=7) compared to CPS < 10 (n=7) had a higher CB rate (57% vs 14%), ORR (14% vs 0%), and prolonged mTOT of 4.4 vs 2.2 months (p=0.059). Conclusions Biomarkers in the tumor microenvironment related to HVEM and PD-L1 expression were identified as potential predictors of CB in response to HFB200603 ± TIS treatment."

Biomarker • Combination therapy • IO biomarker • Monotherapy • Colorectal Cancer • Oncology • Solid Tumor • BTLA • CD8 • PD-L1

Utilizing drug intelligence science (DIS®) for tumor type selection and molecular characterization of HFB200603, a best-in-class B and T lymphocyte attenuator (BTLA) monoclonal antagonist (SITC 2024) - P1 | "Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

IO biomarker • Clear Cell Renal Cell Carcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BTLA • CD8

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 (ESMO 2024) - P1 | "HFB200603 shows favorable safety and dose-dependent PK with receptor saturation. Proof-of-concept is demonstrated by peripheral T cell activation. Accrual is ongoing in pts with heavily pretreated refractory solid tumors."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • BTLA

HiFiBiO Therapeutics to Present Phase 1 Clinical Trial Data for Two Novel Immuno-Oncology Antibodies at the 2024 Annual Congress of the European Society for Medical Oncology (HiFiBiO Press Release) - "HiFiBiO Therapeutics, a clinical stage immune modulation biotechnology company today announced its participation in the 2024 Annual Congress of the European Society for Medical Oncology (ESMO), taking place September 13-17 in Barcelona, Spain....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)....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."

IND • P1 data • Immunology • Inflammation • Solid Tumor

A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=83 | Recruiting | Sponsor: HiFiBiO Therapeutics | Phase classification: P1a/1b ➔ P1

Combination therapy • Metastases • Phase classification • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • BRAF

A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=83 | Recruiting | Sponsor: HiFiBiO Therapeutics | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • BRAF

A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=83 | Not yet recruiting | Sponsor: HiFiBiO Therapeutics

Combination therapy • Metastases • New P1 trial • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • BRAF

HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200603 (Businesswire) - "HiFiBiO Therapeutics...announced today the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for HFB200603. HFB200603 is a novel monoclonal antibody against the immune checkpoint BTLA that blocks the interaction with its ligand, HVEM. HFB200603 is designed to reverse HVEM-mediated immune suppressive effects and induce the production of inflammatory cytokines in various solid tumors selected by HiFiBiO’s proprietary Drug Intelligence Science (DIS™) platform....The planned Phase 1 clinical study will consist of an initial dose escalation followed by expansion cohorts, including combination treatment with Novartis’ Tislelizumab, in selected solid tumors identified through HiFiBiO DIS™ platform."

IND • New P1 trial • Oncology • Solid Tumor

HiFiBiO Therapeutics Announces Clinical Trial Supply Agreement to Evaluate HFB200603 in Combination with Tislelizumab in Patients with DIS Selected Advanced Solid Tumors (Businesswire) - "HiFiBiO Therapeutics...announced today a second clinical trial supply agreement with Novartis to evaluate HiFiBiO’s HFB200603, a novel anti-BLTA monoclonal antibody in combination with tislelizumab, Novartis anti-PD-1 immune checkpoint inhibitor, for the treatment of advanced solid tumor indications preselected by HiFiBiO’s proprietary Drug Intelligence Science (DIS™) platform....Under the terms of the agreement, HiFiBiO Therapeutics will maintain control of the HFB200603 program, including global R&D and commercial rights. Novartis has agreed to supply tislelizumab for use in combination with HFB200603."

Licensing / partnership • Oncology • Solid Tumor