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LSKB ANNOUNCES ITS CLINICAL INITIATIVE TO STUDY THE SAFETY AND EFFICACY OF COMBINING APATINIB WITH IMMUNOTHERAPY
SALT LAKE CITY, USA, December 10, 2017 — LSK BioPharma (LSKB, Company) announced a new initiative to study the safety and efficacy of cancer therapies combining apatinib with immunotherapy. The first clinical study, designated LSK-AM107, will take place at the Cancer Center of Southern California in Santa Monica, California under the direction of Sant P. Chawla, MD, FRACP. The Company has finalized a clinical trial agreement with Dr. Chawla’s institution and will conduct a Site Initiation Visit (SIV) on December 18th, 2017. LSKB expects to recruit patients soon after the SIV.
LSK-AM107, titled “An Open-labeled Phase 1 Study to Evaluate the Safety and Tolerability of Apatinib with Nivolumab in Patients with Unresectable or Metastatic Cancer” is expected to enroll up to 30 patients and will assess the safety of the combination as well as preliminary efficacy from tumor response, progression-free, and overall survival.
Many cancers manipulate normal immune regulatory pathways (immune checkpoints) that allow them to hide from the immune system, shielding tumors from attack by the immune system. Cancer immunotherapy with checkpoint inhibitors such as nivolumab help restore the body’s natural antitumor immune response.
Preclinical research demonstrated the combination of apatinib, an angiogenesis inhibitor, with checkpoint inhibition is highly synergistic in limiting tumor growth. This synergy can be attributed to apatinib’s modulation of the tumor environment through upregulation of checkpoint target ligands, increasing of tumor-infiltrating lymphocytes, and decreasing of tumor immunosuppression.