Elevar Therapeutics to Participate in ASCO 2023 and BIO 2023; New Jersey-based Company Secures State License as It Builds Toward Commercialization FORT LEE, N.J., June 01, 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 its participation plans for the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and the 2023 BIO International Convention in Boston. “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 had one abstract accepted for poster presentation and another for publication only at ASCO 2023, to be held June 2-6 at McCormick Place in Chicago. Presentation details are as follows:
Session Date and Time: June 5, 2023; 1:15-4:15 p.m. CDT
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 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.
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 inhibitorsVEGF 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®. 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). 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 (2023). It has been granted Orphan Drug Designation in the U.S., Europe and South Korea and has been clinically tested in more than 1,000 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: rostmann@rosecomm.com