HBM1020 / Harbour BioMed - LARVOL DELTA

Phase I dose-escalation study of HBM1020: A novel anti-B7H7 antibody in patients with advanced solid tumors (ESMO 2024) - P1 | "HBM1020, as a first-in-class anti-B7H7 antibody, demonstrated promising safety and tolerability profiles in patients with advanced solid tumors. Further studies are warranted to explore the therapeutic potential of HBM1020 in solid tumors."

Clinical • Metastases • P1 data • Oncology • Solid Tumor

Harbour BioMed Announces the Latest Clinical Data on the First-in-Class Fully Human Anti-B7H7/HHLA2 Monoclonal Antibody HBM1020 at the ESMO Congress 2024 (PRNewswire) - P1 | N=50 | NCT05824663 | Sponsor: Harbour BioMed US, Inc | "Harbour BioMed...announced the latest clinical data on HBM1020, a first-in-class, fully human anti-B7H7/HHLA2 monoclonal antibody, in patients with advanced solid tumors...HBM1020 was administered intravenously at dose levels ranging from 0.3 mg/kg to 30 mg/kg every three weeks (Q3W). All 17 patients completed the dose-limiting toxicity (DLT) observation period (21 days), and no DLT events were observed. The maximum tolerated dose (MTD) has not been reached yet; PK analysis of HBM1020 demonstrated typical IgG behavior, with an elimination half-life of approximately two weeks in the dose range of 3 mg/kg to 20 mg/kg; Of the 15 patients who received post-treatment tumor assessments, 7 patients (46.7%) achieved stable disease (SD), with two patients showing tumor shrinkage of 11% and 25%."

P1 data • Solid Tumor

Harbour BioMed to Present the Latest Progress of the First-in-Class Fully Human Anti-B7H7/HHLA2 Monoclonal Antibody HBM1020 at the ESMO Congress 2024 (PRNewswire) - "Harbour BioMed...announced today that the Company will release the latest clinical data on its first-in-class fully human anti-B7H7/HHLA2 monoclonal antibody, HBM1020, for advanced solid tumors at the ESMO Congress 2024, taking place from September 13-17, 2024, in Barcelona, Spain....Data from the dose-escalation study of a phase I, multi-center, open-label trial (NCT05824663) demonstrated the promising safety and tolerability profiles of HBM1020 in patients with advanced solid tumors."

P1 data • Solid Tumor

Harbour BioMed Announces First Patient Dosed in Phase I Study of First-in-Class Anti-B7H7 (HHLA2) Antibody HBM1020 (PRNewswire) - "Harbour BioMed...announced that the first patient has been dosed in its ongoing phase I trial of the first-in-class anti-B7H7 (HHLA2) antibody HBM1020 (NCT05824663/Study 1020.1) in the United States. This study is evaluating the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM1020 in patients with advanced solid tumors....HBM1020 is a first-in-class therapeutic monoclonal antibody against B7H7/HHLA2 entering clinical development globally....HBM1020 has great potential to address huge unmet medical needs in patients with advanced malignancies."

Trial status • Oncology • Solid Tumor

A Study Evaluating the Safety, Tolerance and Anti-tumor Activity of HBM1020 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Harbour BioMed US, Inc.

Metastases • New P1 trial • Colorectal Adenocarcinoma • Oncology • Solid Tumor

Harbour BioMed Announces IND Clearance for First-in-Class Anti-B7H7 Antibody by the U.S. FDA (PRNewswire) - "Harbour BioMed...announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence clinical trials of its globally first-in-class fully human monoclonal antibody HBM1020 targeting B7H7 (also known as HHLA2) in the U.S. This is an open-label and multicenter study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM1020 in patients with advanced solid tumors. HBM1020 is also the globally first-ever monoclonal antibody targeting B7H7 cleared by the regulatory agency for clinical trials."

IND • Oncology • Solid Tumor

HBM1020 Is A Fully Human Novel Anti-B7H7 Antibody with Excellent Preclinical Efficacy and Safety Profile (SITC 2022) - "Ethics Approval The anti-tumor efficacy studies in mice were approved by the internal ethics board of the respective contract research organization (CRO). The dose-range finding toxicity studies in non-human primates were approved by Ethics Board of an appropriate contract research organizations (CROs)."

Preclinical • Bladder Cancer • Colon Cancer • Colorectal Cancer • Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD52 • CTLA4 • PD-1 • PRKDC

Harbour BioMed Announces Upcoming Poster Presentations at the 37th Society for Immunotherapy of Cancer Annual Meeting (PRNewswire) - "Harbour BioMed...announced today that the Company will present new preclinical data of five portfolio assets including HBM7008, HBM7004, HBM1047, HBM1020 and HBM1022 in five poster presentations at the 37th Society for Immunotherapy of Cancer's (SITC) Annual Meeting in Boston, via in person/virtual attendance, November 8-12, 2022."

Preclinical • Oncology • Solid Tumor

Harbour BioMed Announces 2022 Interim Results (PRNewswire) - "HBM9027 is currently in preclinical studies and is expected to be submitted for an IND application in 2023. A number of innovative global programs are expected to file IND by the end of 2022, including HBM1020, HBM1022, and HBM1007."

IND • Oncology

Harbour BioMed Reports 2021 Interim Results (BioSpace) - “HBM1020 is a fully human monoclonal antibody generated from HBM's H2L2 platform. The antibody is directed against a brand-new target in the B7 family and can enhance the anti-tumor immunity by blocking the immune checkpoint target. Preclinical data has demonstrated its immune activation and anti-tumor functional activities. It is expected to file an IND in 2022.”

IND • Oncology

Harbour BioMed Presents Novel Antibody for Cancer Immunotherapy at 2021 American Association for Cancer Research Annual Meeting (PRNewswire) - "Harbour BioMed...presents its newly discovered fully human anti-B7H7 monoclonal antibody at the American Association for Cancer Research Annual Meeting. This meeting is being held virtually from April 10-15, 2021. The anti-B7H7 antibody is a novel immune-oncology antibody with potent anti-tumor activity generated using HBM's proprietary H2L2 Harbour Mice® platform...This antibody generated from H2L2 Harbour Mice® demonstrates excellent preclinical activity and anti-tumor efficacy."

Preclinical • Oncology