HB0045 / Zhejiang Huahai Pharma - LARVOL DELTA

An antibody cocktail targeting two different CD73 epitopes enhances enzyme inhibition and tumor control. (PubMed, Nat Commun) - "HB0045 is a 1:1 mixture of two humanized monoclonal IgG1 antibodies (mAbs), HB0038 and HB0039. In various animal models of syngeneic and xenograft tumors, HB0045 inhibits tumor growth more potently than the single mAbs. Collectively, our findings provide functional and structural insights into the mechanism of a CD73-targeting antibody cocktail."

Journal • Oncology • CD73 • NT5E

A Study of HB0045 Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=71 | Recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • CD4 • MSI

good news! China’s first CD73-targeting cocktail compound antibody HB0045 has been administered to its first patient in the United States [Google translation] (Huabo Biopharm Press Release) - P1/2 | N=71 | NCT06056323 | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | "...Shanghai Huaotai Biopharmaceutical Co., Ltd...announced that the company's independently developed HB0045 project, the first domestic cocktail compound antibody injection targeting CD73, will be launched on October 3, 2023. The first ovarian cancer patient was administered the drug at Gabrail Cancer Center, the top cancer research center in the United States. The patient is currently doing well and no adverse safety events have been reported....Huaotai will continue to rapidly advance the clinical Phase I ramp-up and dose expansion trials of HB0045, and actively explore its synergy with other targets inside and outside the pipeline, broaden the scope of indications, and look forward to bringing more cancer patients more benefits in the future."

Launch • P1/2 data • Trial status • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

A Study of HB0045 Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=71 | Not yet recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

Metastases • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • CD4 • MSI

A Study of HB0045 Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=71 | Not yet recruiting | Sponsor: Huabo Biopharm Co., Ltd.

Metastases • New P1/2 trial • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • CD4 • MSI

Huahai Pharmaceutical (600521.SH): HB0045 Injection for the Treatment of Advanced Solid Tumor Clinical Trial Application Approved by US FDA [Google translation] (Zhitong Finance) - "Huahai Pharmaceutical...announced that the company's subsidiary Shanghai Huaaotai Biopharmaceutical Co., Ltd. independently developed the clinical trial application for HB0045 injection for the treatment of advanced solid tumors, which was approved by the US Food and Drug Administration. Food and Drug Administration (FDA) approved."

IND • Oncology • Solid Tumor