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    Home > Active Ingredient News > Antitumor Therapy > Kangfang Biological AK112 was approved to carry out a phase II clinical study of single-drug or combined chemotherapy with neoadjuvant/adjuvant therapy for resectable NSCLC

    Kangfang Biological AK112 was approved to carry out a phase II clinical study of single-drug or combined chemotherapy with neoadjuvant/adjuvant therapy for resectable NSCLC

    • Last Update: 2021-11-14
    • Source: Internet
    • Author: User
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    On November 2, Kangfang Bio-Bio announced that its self-developed new tumor immunotherapy drug AK112 (PD-1/VEGF bispecific antibody) has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration to develop single-drug or Combination chemotherapy with neoadjuvant/adjuvant therapy can cut the phase II clinical study of non-small cell lung cancer (NSCLC)
    .

    Lung cancer is one of the cancers with the highest morbidity and mortality in the world, and about 85% of them are NSCLC
    .

    At present, the consensus of NSCLC neoadjuvant immunotherapy is: patients with resectable stage IB-IIIA NSCLC can consider neoadjuvant immunotherapy combined with platinum-containing dual-agent chemotherapy or neoadjuvant immune monotherapy before surgery
    .

    The efficacy of immunotherapy combined with chemotherapy is better than chemotherapy, and the safety is controllable, but the improvement of pathological remission rate is limited
    .

    Immune checkpoint inhibitors combined with anti-angiogenesis drugs have been observed to have synergistic effects in multiple tumor types, so PD-1/VEGF dual antibody combined with chemotherapy is expected to achieve better clinical benefits
    .

    AK112 is designed based on Kangfang's unique TETRABODY technology, which can block the binding of PD-1 to PD-L1 and PD-L2, and at the same time block the binding of VEGF to VEGF receptors
    .

    The combination therapy of PD-1 antibody and VEGF blocker has shown strong curative effect in a variety of tumor types such as renal cell carcinoma, non-small cell lung cancer and hepatocellular carcinoma
    .

    In view of the co-expression of VEGF and PD-1 in the tumor microenvironment, compared with combination therapy, AK112 as a single drug to block these two targets at the same time may block these two pathways more effectively, thereby enhancing anti-tumor Active
    .

    In early clinical studies, AK112 has shown good safety and tolerability in the treatment of various types of lung cancer including NSCLC and small cell lung cancer (SCLC), and has also shown excellent anti-tumor effects
    .

    On September 26, 2020, Kangfang Biological released the latest phase II clinical data of AK112 combined with chemotherapy in the first-line treatment of advanced non-small cell lung cancer, showing that the control rate of AK112 on non-small cell lung cancer can reach 100%! It is reported that the registration phase III clinical study of AK112 for the treatment of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment of NSCLC has started; AK112 first-line treatment drives the gene-negative PD-L1-positive NSCLC phase III Clinical studies and Phase III clinical studies of AK112 for the first-line treatment of extensive-stage SCLC are about to start
    .

    End reference materials: [1]https://mp.
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