BLB-01D1 is under clinical development by Systimmune and currently in Phase III for Esophageal Squamous Cell Carcinoma (ESCC). According to GlobalData, Phase III drugs for Esophageal Squamous Cell Carcinoma (ESCC) have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how BLB-01D1’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.

BLB-01D1 overview

BLB-01D1 (BLB-029A1,SIB-029A) is under development for the treatment of HER 2 negative breast cancer, epithelial tumor, advanced or metastatic urologic tumors, metastatic breast cancer, advanced or metastatic gastrointestinal tumors and Triple-Negative Breast Cancer (TNBC), non-small cell lung cancer, head and neck squamous cell carcinoma, recurrent head and neck squamous cell carcinoma nasopharyngeal carcinoma, small cell lung cancer, metastatic ovarian cancer, epithelial ovarian cancer, primary peritoneal cancer, endometrial cancer, vulvar cancer, vaginal cancer and primary sarcoma of the gynecological reproductive system, cervical cancer, fallopian tube cancer, metastatic urothelial carcinoma, prostate cancer, renal cell carcinoma, gastric cancer, metastatic colorectal cancer and penile cancer. The therapeutic candidate is a bispecific EGFRxHER3 antibody-drug conjugate (ADC) with a Topo-1 inhibitor payload and a cleavable linker.
It was also under development for the treatment of lung cancer, colon cancer, head and neck cancer. It is administered through intravenous, intravenous drip route and parenteral.

Systimmune overview

Systimmune, a subsidiary of Sichuan Biokin Pharmaceutical Co Ltd, is a biopharmaceutical company. It utilizes specificity-enhanced bi-specific antibody (SEBA), guidance and navigation control (GNC) and HIRE-ADC platforms to develop novel therapeutic bi-specific, multi-specific antibodies and antibody-drug conjugates (ADCs) for the treatment of cancer. The company’s pipeline products include SI-B001, SI-B003, BL-B01D1, BL-M07D1 and BL-M02D1 target solid tumors; GNC-038, GNC-035 and GNC-039 treats lymphoma, leukemia, solid tumors and glioblastoma; and BL-M11D1 and BL-M05D1 are monospecific antibodies for R/R AML (acute myeloid leukemia) and gastric cancer. Systimmune is headquartered in Redmond, Washington, the US.

For a complete picture of BLB-01D1’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

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.