On June 1, 2023 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, reported its participation plans for the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago and the 2023 BIO International Convention in Boston (Press release, Elevar Therapeutics, JUN 1, 2023, View Source [SID1234632338]).
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Elevar, which in mid-May submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line treatment option for unresectable hepatocellular carcinoma (uHCC), also announced that it secured its license to operate as a pharmaceutical wholesaler in New Jersey, part of a process of nationwide licensure as it prepares for commercialization.
"Elevar Therapeutics is highly focused on building our sales and distribution infrastructure, and on creating new relationships in the global biotechnology community as we await the potential approval of our NDA for the combination of rivoceranib and camrelizumab as a treatment option for uHCC," said Elevar Chief Executive Officer Saeho Chong. "We look forward to discussing Elevar’s momentum in HCC and adenoid cystic carcinoma (ACC) with peers at these two prestigious gatherings."
Elevar has one abstract accepted for poster presentation and another for publication only at ASCO (Free ASCO Whitepaper) 2023, to be held June 2-6 at McCormick Place in Chicago. Presentation details are as follows:
Abstract Title: Updated results from a phase 2 study of the oral vascular endothelial growth factor receptor 2 (VEGFR2) inhibitor rivoceranib for recurrent or metastatic (R/M) adenoid cystic carcinoma (ACC)
Session Title: Head and Neck Cancer
Session Date and Time: June 5, 2023; 1:15-4:15 p.m. CDT
Presenter: Hyunseok Kang, M.D., MPH, University of California, San Francisco
Abstract Number: 6040
Poster Bd #: 32
Clinical Trial Registration Number: NCT04119453
Abstract Title: Phase 1, randomized, open-label, single-dose, crossover study to evaluate the bioequivalence of four formulations of oral rivoceranib tablets in healthy subjects
Session Title: Publication Only: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract Number: e15122
Clinical Trial Registration Number: NCT05287360
Elevar also will attend BIO 2023, to be held June 5-8 at the Boston Convention & Exhibition Center in Boston, as it seeks partnership for global commercialization of rivoceranib. BIO is the world’s largest advocacy association in its field, representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the U.S. and in more than 30 countries.
In March, Elevar announced its move to a new corporate headquarters in Fort Lee, New Jersey. It has now obtained its New Jersey Resident State Facility Inspection Report and is a licensed pharmaceutical wholesaler in the state, part of its strategic nationwide state licensing process.
"Securing a license to operate as a pharmaceutical wholesaler in New Jersey, where Elevar Therapeutics is headquartered, marks another milestone in a process that is vital to a successful product launch," said Elevar Chief Commercial Officer Paul Friel. "All 50 states and Washington, D.C. have a license requirement to sell, market and/or ship from or into their borders, and each has its own independent regulatory framework. We look forward to gaining licensure in every U.S. state as we prepare for commercialization of rivoceranib."
To learn more, visit ElevarTherapeutics.com.
About Hepatocellular Carcinoma (HCC)
HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.
About Rivoceranib
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 as a first-line treatment for uHCC in combination with camrelizumab (February 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.
About Camrelizumab
Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting 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) 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), 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 Adenoid Cystic Carcinoma (ACC)
ACC is a rare malignancy that occurs within the secretory glands, most commonly in the major and minor salivary glands of the head and neck, but also found in the breast, skin and elsewhere. It is diagnosed in about 4 of every 1 million people each year – representing a combined 3,100 annual cases in the U.S., EU and Japan – and it afflicts more than 200,000 patients throughout the world, accounting for 5 percent to 7 percent of all head and neck malignancies, according to the Adenoid Cystic Carcinoma Research Foundation. There is no approved standard of care for R/M ACC patients. A previous study showed a baseline progression-free survival (PFS) of 2.8 months for ACC (Kang EJ, et al. Clin Cancer Res. 2021;27:5272-5279).