LSK BioPharma and Jiangsu Hengrui Medicine Announce FDA Clearance to Initiate a Phase 3 Clinical Trial in Advanced Hepatocellular Carcinoma (HCC)

April 8, 2019 |

5 min read

LSK BioPharma and Jiangsu Hengrui Medicine, Co., Ltd. announced that the Companies have received FDA clearance to initiate a clinical trial in the United States

SALT LAKE CITY and SHANGHAI, April 8, 2019 /PRNewswire/ -- LSK BioPharma (or “LSKB”), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or “Hengrui”), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, today announced that the Companies have received FDA clearance to initiate a clinical trial in the United States in first-line patients with advanced hepatocellular carcinoma (HCC), evaluating the safety and efficacy of LSKB’s rivoceranib, a selective VEGFR-2 inhibitor commonly known as apatinib, in combination with Hengrui’s camrelizumab (SHR-1210), a humanized anti-PD-1 monoclonal antibody currently under NDA review in China for classic Hodgkin’s Lymphoma (cHL).

“We are happy with this important regulatory milestone in our global clinical collaboration,” said Dr. Sung Chul Kim, LSKB’s President. “We are enthusiastic to work with Hengrui to hopefully help more HCC patients through development of this combination therapy.”

“As one of the leading biopharmaceutical companies in China, Hengrui is committed to developing breakthrough medicines for patients worldwide. This milestone is another step towards our mission. We look forward to working with LSKB to jointly make a difference for HCC patients around the world,” said Dr. Piaoyang Sun, Chairman of Hengrui.

Currently, Hengrui is conducting an open-label, single arm multicenter phase 2 study (NCT03463876) to evaluate the efficacy and safety of the combination of camrelizumab and apatinib in patients with advanced HCC in China, where Hengrui has received approval of apatinib monotherapy for advanced gastric cancer. At ASCO 2018, it was reported that the objective response rate (ORR) and disease control rate (DCR) were 50.0% and 85.7%, respectively, among 14 evaluated advanced HCC patients treated by camrelizumab in combination with apatinib in an open-label, phase 1 study in China (Xu et al., NCT02942329). In addition, camrelizumab and apatinib combination therapy is also being evaluated by Hengrui for multiple indications including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC) in China.

Based upon earlier studies, it is hypothesized that the combination of rivoceranib and camrelizumab may enhance the immune system, aiding the fight against cancer. In addition to the known anti-angiogenic effects of rivoceranib, it may also enhance camrelizumab’s anti-tumor activity by normalizing tumor vasculature and reversing the tumor suppressive immune microenvironment.

About Rivoceranib (Apatinib)

Rivoceranib, also known as apatinib or Aitan^® (brand name) in China, is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib is investigational outside of China including in the United States; and safety and efficacy have not been established. It acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis.

Hengrui, who owns the China rights to rivoceranib, received the approval from China National Medical Products Administration (NMPA, formerly known as CFDA) in 2014 to market the drug under the brand name Aitan^® in China for advanced gastric cancer. LSKB, which holds the global rights (ex-China), has completed enrollment of a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib (apatinib) is currently listed in 220 clinical studies on www.clinicaltrials.gov with over 20,000 patients enrolled or planned to be enrolled in trials targeting numerous cancers including GC, colorectal cancer (CRC), HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to improve outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib 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.

Rivoceranib was developed by Advenchen Laboratories in Southern California under the designation YN968D1. The compound was exclusively licensed to Hengrui in China (2005) and LSKB (2007) for rest of the world.

About Camrelizumab (SHR-1210)

Camrelizumab (SHR-1210) is an investigational humanized monoclonal antibody recognizing the programmed death-1 (PD-1) receptor. Camrelizumab functions as an immune checkpoint inhibitor by specifically blocking the interaction between PD-1 and PD-L1 and reversing the immunosuppressive signal of PD-1 on the T cell. Approximately 20 clinical trials on camrelizumab in multiple indications including lung cancer, liver cancer, gastric cancer, esophageal cancer, nasopharyngeal carcinoma, lymphoma, melanoma and other advanced solid tumors are being conducted in China and Australia as monotherapy or in combination with other therapeutic agents. A marketing application for camrelizumab for relapsed/refractory classic Hodgkin’s Lymphoma was submitted by Hengrui to China NMPA, which was accepted in April 2018, and is currently under review.

About LSK BioPharma

LSKB is a privately-held biopharmaceutical company with offices in Utah, California, and South Korea. LSKB specializes in the clinical development of promising targeted therapies for unmet medical needs in cancer. LSKB’s lead proprietary drug candidates is rivoceranib, a selective VEGFR-2 inhibitor which has demonstrated clinical efficacy in a variety of solid tumors. LSKB can be found on the web at www.lskbiopharma.com.

About Jiangsu Hengrui Medicine Co., Ltd.

Jiangsu Hengrui Medicine Co., Ltd., established in 1970, is a leading biopharmaceutical company based in China with annual net sales of over $2.2 billion in 2017. Hengrui is devoted to empowering healthier lives through research, with a team of over 20,000 employees in China, the United States, Australia, Japan and Germany. Hengrui currently has 4 China NMPA approved new molecular entities, 2 programs under China NDA as well as over 35 new molecular entities in clinical development in China, the United States, and Australia, across oncology, anesthesiology and pain management, immunology & inflammation, and cardiovascular and metabolic diseases. For additional information, please visit http://www.hrs.com.cn and https://www.hengruitx.com.