GNC-035 is under clinical development by Systimmune and currently in Phase II for Relapsed Chronic Lymphocytic Leukemia (CLL). According to GlobalData, Phase II drugs for Relapsed Chronic Lymphocytic Leukemia (CLL) have a 29% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how GNC-035’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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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.
GNC-035 overview
GNC-035 is under development for the treatment of solid tumor, lung cancer, gastric cancer, ovarian cancer, advanced or metastatic breast cancer, relapsed or refractory non-Hodgkin’s lymphoma, relapsed or refractory chronic lymphocytic leukemia (CLL/SLL), relapsed or refractory acute B-lymphocytic leukemia, relapsed or refractory acute myeloid leukemia and relapsed or refractory philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia. The therapeutic candidate is a tetra specific octavalent, which acts by targeting ROR1, PDL1, 4-1BB and CD3. It is administered through intravenous route.
It was also under development for the treatment of relapsed or refractory hematological tumor and triple negative breast cancer.
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 GNC-035’s drug-specific PTSR and LoA scores, buy the report here.
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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.
