FORT LEE, N.J., Aug. 03, 2023 (GLOBE NEWSWIRE) — Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced it will host a virtual key opinion leader (KOL) event on August 10, 2023, at 10 a.m. ET to discuss the Phase 3 study of rivoceranib in combination with camrelizumab in unresectable hepatocellular carcinoma (uHCC). The study resulted in a new drug application filing with the U.S. Food and Drug Administration (FDA) and a May 2024 Prescription Drug User Fee Act (PDUFA) date.
To register for the KOL event, please visit the event page.
The event will feature Amit Mahipal, MBBS, MPH (University Hospitals Seidman Cancer Center, Case Western Reserve University) and Ghassan K. Abou-Alfa, M.D. (Memorial Sloan Kettering Cancer Center), who will discuss the current treatment landscape for patients suffering from uHCC, along with the prospects for rivoceranib, a highly potent VEGFR-2 inhibitor, as a potential treatment solution.
The discussion will focus on data from the Phase 3 CARES 310 study, which evaluated the combination of rivoceranib and camrelizumab versus sorafenib in the first-line setting for uHCC. The FDA granted rivoceranib an orphan drug designation in uHCC.
Saeho Chong, Ph.D., chief executive officer of Elevar Therapeutics, will provide an overview of the company’s next steps and future directions, providing insight into the recent NDA and acceptance by the FDA.
A live question and answer session will follow the formal presentations.
About Amit Mahipal, MBBS, MPH
Dr. Mahipal is Professor of Medicine in the Department of Hematology and Oncology and Director of GI Oncology at the University Hospitals Seidman Cancer Center at Case Western Reserve University. Dr. Mahipal earned his medical degree from Maulana Azad Medical College at Delhi University in New Delhi, India, followed by his MPH in Epidemiology from the University of Minnesota. He completed his residency in Internal Medicine at the University of Connecticut Health Center and his Fellowship in Hematology/Oncology at Thomas Jefferson University Hospital in Philadelphia.
About Ghassan K. Abou-Alfa, M.D.
Dr. Abou-Alfa is a medical oncologist at Memorial Sloan Kettering Cancer Center, specializing in the treatment and management of gastrointestinal malignancies, with a particular focus on liver cancer (hepatocellular carcinoma) and biliary tract cancers (cholangiocarcinoma). At MSKCC, Dr. Abou-Alfa has held various positions, including serving as the Clinical Director of the Gastrointestinal Oncology Service and as an Attending Physician in the Department of Medicine. He has been actively involved in clinical research, exploring novel treatment approaches and therapeutic strategies for liver and biliary tract cancers. Dr. Ghassan K. Abou-Alfa received his medical degree from the American University of Beirut Faculty of Medicine in Lebanon. He then pursued further training in the United States, completing his residency in internal medicine at the State University of New York (SUNY) Downstate Medical Center in Brooklyn. Following his residency, he went on to complete a fellowship in medical oncology at the Mayo Clinic in Rochester, Minnesota.
About Hepatocellular Carcinoma (HCC)
HCC is the most common type of primary liver cancer. It accounts for approximately 90% of primary liver cancers and most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC is often diagnosed at an advanced stage and typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.
Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf®). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China in combination with camrelizumab as a first-line treatment for uHCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan®.
Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer, etc.) and treatment settings.
Camrelizumab, under the brand name AiRuiKa®, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for uHCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021.
About Elevar Therapeutics
Elevar Therapeutics, Inc. is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar’s lead proprietary drug candidate is rivoceranib. Rivoceranib, under the name apatinib in China, is commercialized by Hengrui Pharma in China and was approved in China as a single agent for the treatment of gastric cancer (2014), a second-line treatment for advanced HCC (2020), and first-line treatment in combination with camrelizumab for uHCC (January 2023). It has been granted Orphan Drug Designation in the U.S., Europe and South Korea and has been clinically tested in more than 6,000 patients worldwide in numerous cancer indications. Elevar is headquartered in New Jersey, with offices in Ireland and South Korea. Additional information is available at ElevarTherapeutics.com.
Email: [email protected]
Investor Relations Contact:
LifeSci Advisors, LLC
Ashley R. Robinson
Email: [email protected]