LSKB Announces its Clinical Initiative to Study the Safety and Efficacy of Combining Apatinib with Immunotherapy

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.

LSKB is also planning to support an Investigator Initiated Trial (IIT) at a US institution studying the safety and efficacy of apatinib in combination with pembrolizumab. This study is expected to enroll its first patients in early 2018.

About Apatinib Apatinib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Apatinib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, apatinib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. LSK BioPharma, which holds the global rights (ex-China), has partnered development and marketing in South Korea with Bukwang Pharmaceutical Co., Ltd. The Company is currently conducting a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) Phase 3 clinical trial of apatinib in advanced or metastatic gastric cancer patients. Apatinib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating apatinib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.

About CCSC and SORC

The Cancer Center of Southern California (CCSC) and Sarcoma Oncology Research Center (SORC) is a fully integrated cancer treatment and clinical research center, led by Founder and Director, Sant P. Chawla, MD, FRACP.  Dr. Chawla is a recognized leader in the field of sarcoma and oncology, combining FDA approved treatments with emerging investigational medicine via clinical trials, for optimal patient care. The SORC specializes in trials for rare sarcomas, solid tumors and phase 1 research.  As a private research institution, SORC/CCSC delivers highly personalized care and offers expanded treatment options for patients through research based treatments, as clinically indicated.  Dr. Chawla has conducted clinical research for more than 30 years, making key contributions to many clinical development programs.

About LSK BioPharma LSKB is a privately-held biopharmaceutical company based in Salt Lake City, Utah. The Company specializes in clinical development of promising targeted therapies for unmet medical needs in cancer. LSKB is developing two proprietary drug candidates; apatinib, a selective VEGFR-2 inhibitor which has demonstrated clinical efficacy in a variety of solid tumors and a selective BTK/JAK3 inhibitor (designated LSK9985) with the potential to treat hematologic malignancies and rheumatoid arthritis as an immunosuppressive agent. LSKB can be found on the web at www.lskbiopharma.com.

Contact: Angie Price angieprice@lskbiopharma.com

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