Trastuzumab imbotolimod is under clinical development by Bolt Biotherapeutics and currently in Phase II for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer). According to GlobalData, Phase II drugs for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) have a 45% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Trastuzumab imbotolimod’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Trastuzumab imbotolimod overview

Ttrastuzumab imbotolimod (BDC-1001) is under development for the treatment of HER2 low expressing and HER2 positive breast and non-breast HER2 advanced malignancies including gastric cancer, gastroesophageal, colorectal cancer and endometrial cancer. It is administered through the intravenous route. BDC-1001 is a HER2 ISAC comprised of trastuzumab biosimilar (EG12014) conjugated with a non-cleavable linker to a proprietary TLR7/8 agonist payload. It acts by targeting toll-like receptor 7 (TLR7) and toll-like receptor 8 (TLR8). The drug candidate is developed based on the immune-stimulating antibody conjugate (ISAC) platform and Boltbody technology.

Bolt Biotherapeutics overview

Bolt Biotherapeutics is a clinical-stage biopharmaceutical company that develops novel immunotherapies for the treatment of cancer. The company develops immuno-oncology therapeutics by using the Boltbody ISAC platform. Its pipeline products include BDC-1001 and BDC-3042. Its BDC-1001 product treats HER2-positive colorectal, endometrial, gastroesophageal and metastatic breast cancer. Bolt Biotherapeutics’ BDC-3042 product treats solid tumors. Its Boltbody ISAC platform works in collaboration with Genmab A/S, Innovent Biologics, Inc and Toray Membrane USA, Inc. Bolt Biotherapeutics is headquartered in Redwood City, California, the US.

For a complete picture of Trastuzumab imbotolimod’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 February 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.