HBM7008 / Harbour BioMed - LARVOL DELTA

CLN-418-001: CLN-418 Study on Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Cullinan Therapeutics Inc. | Recruiting ➔ Completed | N=108 ➔ 48 | Trial completion date: Jun 2024 ➔ Sep 2024

Enrollment change • Metastases • Trial completion • Trial completion date • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results (GlobeNewswire) - "CLN-418 (B7H4x4-1BB bispecific immune activator):...Following a review of the data from the Phase 1 study of CLN-418, Cullinan plans to discontinue development and has notified Harbour BioMed of termination of the license agreement. In connection with the termination, Cullinan will return development and commercial rights to Harbour BioMed."

Licensing / partnership • Solid Tumor

The clinical-stage bispecific B7H4x4-1BB agonist, CLN-418, elicits robust B7H4-dependent immune activation and potent single-agent anti-tumor efficacy (CIMT 2024) - P1 | "Collectively, enriched expression of B7H4 and 4-1BB in tumors, together with robust B7H4-dependent single-agent efficacy of CLN-418 in preclinical tumor models, support the development of CLN-418 in patients with difficult-to-treat solid cancers. CLN-418-001 (NCT05306444) is a phase 1 open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CLN-418 in subjects with advanced solid tumors."

Clinical • IO biomarker • Hepatology • Oncology • Ovarian Cancer • Solid Tumor • PD-L1 • VTCN1

Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results (GlobeNewswire) - "CLN-418: Cullinan expects to provide a clinical data update from the ongoing Phase 1 dose escalation study in patients with advanced solid tumors in the second half of 2024; CLN-617: Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors.:"

Enrollment status • P1 data • Oncology • Solid Tumor

Cullinan Oncology to Present Data Demonstrating Progress Across Its Broad Immunotherapy-Pipeline at SITC 2023 (GlobeNewswire) - "Additional presentations will highlight preclinical data for three other assets: our B7H4X4-1BB bispecific immune activator (CLN-418), our T cell-engaging, CD19-targeted bispecific antibody (CLN-978), and our collagen-binding IL-2/IL-12 fusion protein (CLN-617), as well as a Trials in Progress presentation for CLN-617.”"

Clinical data • Oncology • Solid Tumor

CLN-418, a clinical-stage B7H4 x 4–1BB bispecific antibody with potential to treat patients with a wide range of solid tumors (SITC 2023) - P1 | "Conclusions B7H4 and 4–1BB expression in cancer cells, PBMC and solid tumors, together with robust B7H4-dependent single agent activity of CLN-418 in preclinical tumor models, support the development of CLN-418 in patients with difficult-to-treat solid cancers. A Phase 1 dose-escalation trial of CLN-418 is ongoing (NCT05306444)."

Clinical • IO biomarker • Breast Cancer • Endometrial Cancer • Oncology • Solid Tumor • CD8 • PD-L1 • VTCN1

Cullinan Oncology Provides Corporate Update and Reports Second Quarter 2023 Financial Results (GlobeNewswire) - "CLN-619: Cullinan intends to present initial data from the combination dose escalation arm of the study at a medical meeting in the future; CLN-418: Enrollment continued in the ongoing Phase 1 dose escalation study in patients with advanced solid tumors. Initial clinical data are expected in 2024; CLN-617: Cullinan received FDA clearance of its IND application for CLN-617 in March and anticipates initiating a Phase 1 clinical study in the second half of 2023."

P1 data • Trial initiation date • Oncology • Solid Tumor

CLN-418 Study on Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: Cullinan Oncology, LLC | Trial completion date: Dec 2023 ➔ Jun 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results (GlobeNewswire) - "CLN-418....Enrollment is ongoing in a Phase 1 dose escalation study at U.S. and Australian sites in patients with advanced solid tumors with initial clinical data expected in 2024....Consistent with prior guidance, Cullinan received FDA clearance of its Investigational New Drug (IND) application for CLN-978 in January and anticipates initiating a Phase 1 clinical study by the end of 2023....Consistent with prior guidance, Cullinan recently filed the IND application for CLN-617 in February 2023 and intends to initiate a Phase 1 clinical study by the end of 2023, pending IND clearance."

IND • New P1 trial • P1 data • Oncology • Solid Tumor

Cullinan Oncology Licenses U.S. Rights to the First Clinical-Stage B7H4 x 4-1BB Bispecific Immune Activator from Harbour BioMed (GlobeNewswire) - "Cullinan Oncology...and Harbour BioMed...announced that Cullinan Oncology has entered into an exclusive license with Harbour BioMed for the development and commercial rights of HBM7008 (CLN-418) in the U.S. CLN-418/HBM7008 is a B7H4 x 4-1BB bispecific immune activator developed from next-gen heavy chain only antibody (HCAb)-based multi-specific antibody discovery platform HBICE®, currently in a Phase 1 clinical study being conducted at U.S. and Australian sites in patients with advanced solid tumors....Under the agreement, Cullinan Oncology will pay Harbour BioMed an upfront license fee of $25 million at closing for the exclusive right to develop and commercialize CLN-418/HBM7008 in the U.S. Harbour BioMed will be eligible to receive up to $148M in development and regulatory milestones plus up to an additional $415M in sales-based milestones as well as tiered royalties up to high teens on potential U.S. commercial sales."

Licensing / partnership • Oncology • Solid Tumor

HBM7008 (B7H4x4-1BB HBICE) Synergizes HBM7004 (B7H4xCD3 HBICE) for Solid Tumor Therapy (SITC 2022) - "Ethics Approval The cancer tissue microarray was purchased from Fanpu Biotech, Inc. The company ensured ethical approval from the patients, and patient consent for publication."

IO biomarker • Hematological Malignancies • Oncology • Solid Tumor • HER-2 • TNFRSF9 • VTCN1

HBM7008, a first-in-class bispecific antibody targeting both B7-H4 and 4-1BB, exhibits robust anti-tumor immunity and low toxicity through B7-H4-directed 4-1BB activation (SITC 2022) - "However, 4-1BB agonistic antibody urelumab shows dose-limiting hepatotoxicity in clinical trials. The anti-tumor efficacy and pharmacodynamics studies in mice were approved by the internal ethics board of the respective contract research organization (CRO). The good laboratory practice-compliant toxicity studies in non-human primate were approved by Ethics Board of an appropriate contract research organizations (CROs)."

Cervical Cancer • Endometrial Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD8 • VTCN1

Harbour BioMed Announces Dosing of First Patient in Phase I Trial of B7H4x4-1BB Bispecific Antibody in the United States (PRNewswire) - "Harbour BioMed...announced that, it has successfully completed the dosing of first patient in the global phase I trial of B7H4x4-1BB bispecific antibody HBM7008 in the United States. This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of HBM7008 in patients with solid tumors."

Trial status • Oncology • Solid Tumor

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 IND Clearance for B7H4x4-1BB Bispecific Antibody by the U.S. Food and Drug Administration (PRNewswire) - "Harbour BioMed...announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the B7H4x4-1BB bispecific antibody (HBM7008), which has successfully completed the dosing of first patient in the phase I trial of HBM7008 in Australia in May 2022 and received an IND approval from China National Medical Products Administration in early June 2022."

IND • Oncology • Solid Tumor

Harbour BioMed Announces IND Approval for B7H4x4-1BB Bispecific Antibody (PRNewswire) - "Harbour BioMed...announced that China National Medical Products Administration (NMPA) had approved the investigational new drug (IND) application to commence phase I trial of its B7H4x4-1BB bispecific antibody (HBM7008) in China. This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of HBM7008 in patients with solid tumors. It has successfully completed the dosing of first patient in the phase I trial of HBM7008 in Australia on 25 May 2022."

New P1 trial • Oncology • Solid Tumor

Harbour BioMed Announces Dosing of First Patient in Phase I Trial of B7H4x4-1BB Bispecific Antibody (PRNewswire) - "Harbour BioMed...announced that it has successfully completed the dosing of first patient in phase I trial of B7H4x4-1BB bispecific antibody HBM7008 in Australia. This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of HBM7008 in patients with solid tumors."

Trial status • Oncology • Solid Tumor

HBM7008 -Study on Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: Harbour BioMed US, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

HBM7008 -Study on Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=108 | Not yet recruiting | Sponsor: Harbour BioMed US, Inc.

New P1 trial • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Harbour BioMed Announces Approval for Phase I Trial of B7H4x4-1BB Bispecific Antibody in Australia (PRNewswire) - "Harbour BioMed...announced that, it has been approved by the Institutional Review Boards (the 'IRBs') to commence phase I trial of its B7H4x4-1BB bispecific antibody (HBM7008) in Australia. This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of HBM7008 in patients with solid tumors."

New P1 trial • Oncology • Solid Tumor

Harbour BioMed Reports 2021 Interim Results (PRNewswire) - "HBM7008: HBM7008 is a bispecific antibody targeting Tumor Associated Antigen (B7H4)x4-1BB...It is expected to file a CTA/IRB submission in the second half of 2021; HBM1007: HBM1007 is a fully human monoclonal antibody against CD73 generated from HBM's H2L2 platform...HBM1007 is being studied in preclinical setting and an IND application is expected to be submitted in 2022."

Clinical • IND • Oncology