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LOXO-305 is a highly specific, non-common BTK inhibitor developed by precision therapy company Loxo Oncology.
2019, Lilly acquired Loxo Oncology for about $8 billion, acquiring a range of new drugs, including LOXO-305.
screenshot source: CDE website Bruton tyrosine kinase (BTK) plays a key role in B cellularular conductor (BCR) signaling.
BTK responds to BCR signals, causing B cells to survive, multiply, differentiate, and produce antibodies.
BTK is missing, the BCR signal is not sufficient to induce the differentiation of B cells.
addition, BTK mutations can cause abnormal BCR signal conduction.
BTK has been identified as a molecular target in a variety of B-cell leukemias and lymphomas.
LOXO-305 is a highly specific, non-co-priced BTK inhibitor that binds to BTK reversibleity and is designed to be developed to address cancer patients who are resistant or insuperable to current BTK inhibitors.
It is highly active not only for wild-type BTK, but also for BTK, which carries the cysteine-481 (C481) mutation, which is the main cause of tumor resistance to co-priced BTK inhibitors.
, LOXO-305 is currently conducting Phase 1/2 clinical trials worldwide.
September, the FDA awarded LOXO-305 orphan drugs for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
at the 2019 annual meeting of the American Society of Hematology (ASH), Lilly announced the results of phase 1/2 clinical trials of LOXO-305 for the treatment of patients with B-cell malignancies such as chronic lymphoblastic leukemia and set cell lymphoma (MCL).
data show that LOXO-305 provides objective remission in a variety of dosages, and these patients have received a variety of pre-treatment and demonstrated access to the drug.
a total of 28 patients were treated with LOXO-305 in a Phase 1/2 clinical trial called BRUIN.
results showed that out of 13 CLL patients who could be evaluated, 10 patients had a response (8 partial remission, 2 partial remission and lymphocyte growth), reaching a total remission rate of 77%.
of the six MCL patients who could be evaluated, 1 patient achieved complete remission, 2 reached partial remission, with a total remission rate of 50%, and two of the patients who were relieved had previously progressed after treatment with other BTK inhibitors.
the arrival of BTK inhibitors provides treatment options for patients with B-cell malignancies such as leukemia and lymphoma, but there are still patients with access resistance or insuperableness.
LOXO-305 is expected to offer a new treatment option for this type of patient.
: The Drug Review Center of the State Drug Administration of China. Retrieved Nov 24, 2020, from [2]Lilly Presents Interim Clinical Data from LOXO-305 Dose Escalation Trial in B-Cell Leukemias and Lymphomas at the American Society Hematology Annual Meeting. Retrieved December 9, 2019, from [3] Results from the First-in-Human, Proof-of-Concept Phase 1 BRUIN Trial in Pretreated B-Cell Malignancies for LOXO-305, a Next-Generation, Highly Selective, Non-Covalent BTK Inhibitor. Retrieved December 9, 2019, from Source: Medical Mission Hills