Collaboration with Everest Medicines will address critical unmet medical needs for patients with active lupus nephritis in Asia
Kezar is eligible to receive up to $132.5 million in total payments plus tiered royalties
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–$Republic of Kazakhstan—Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncological diseases, today announced a strategic partnership with Everest Medicines, a biopharmaceutical company engaged in leading and oncology diseases, has entered into a collaboration and licensing agreement dedicated to the development, manufacturing and commercialization of innovative medicines and vaccines to develop and commercialize Kezar’s novel, best-in-class selectivity in Greater China, South Korea and Southeast Asia. Immunoproteasome inhibitor Zetomipzomib.
Under the terms of the agreement, Kezar will receive an initial upfront payment, as well as future payments upon achievement of development, regulatory and commercialization milestones, which could total up to $132.5 million. Everest Medicines will also pay tiered royalties based on net sales. Everest Medicines will have exclusive development and commercialization rights to zetomizomib in Greater China, South Korea, Singapore, Malaysia, Thailand, Indonesia, Vietnam and the Philippines.
Everest Medicines, together with Kezar, will conduct PALIZADE, a global, placebo-controlled Phase 2b clinical trial evaluating zetomizomib in patients with active lupus nephritis (LN) in Greater China, South Korea and Southeast Asia. Everest Medicines has a successful track record of conducting clinical trials in kidney disease, which offers the potential to accelerate enrollment in these regions. For the PALIZADE trial, Everest Medicines will contribute its local regulatory and clinical trial expertise and will be responsible for study costs in the licensing region. In addition to LN, Kezar and Everest Medicines have the opportunity to collaborate on future clinical trials and indications to continue the development of Zetomipzomib.
“The collaboration with Everest Medicines is an important milestone in the development of Zetomipzomib. ” said Kezar co-founder and CEO John Fowler. “Everest stood out as the ideal regional partner due to its strong focus on nephrology and a talented team with deep global pharmaceutical experience. Clearly, they understand the broad potential of zetomizomib and their team will integrate seamlessly with ours to help drive enrollment in our global lupus nephritis trial, PALIZADE. It is known that many autoimmune diseases, including LN and SLE, have a higher prevalence in Asia, and we are pleased that through this collaboration, more patients in need will have access to zetomizomib. “
It is estimated that there are 1 million patients with systemic lupus erythematosus (SLE) in China, and 40-60% of SLE patients suffer from kidney disease. Infection is the main cause of death among SLE patients in China, accounting for 65% of deaths.
“We are pleased to enter into our partnership with Kezar through our collaboration on zetomizomib,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Renal and autoimmune diseases are key therapeutic areas for Everest. We look forward to working closely with our partners on clinical trials and leveraging Everest’s strong expertise in clinical development and regulatory filings to bring this innovative therapy to the region as quickly as possible. “
Stifel served as Kezar Life Sciences’ exclusive financial advisor in this transaction.
Zetomipzomib (KZR-616) is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential in multiple autoimmune diseases. Preclinical studies have shown that selective immunoproteasome inhibition can produce broad anti-inflammatory responses in animal models of multiple autoimmune diseases while avoiding immunosuppression. Data generated from Phase 1 and 2 clinical trials demonstrate that zetomipzomib exhibits favorable safety and tolerability in the treatment of severe chronic autoimmune diseases.
PALIZADE is a global, placebo-controlled, randomized, double-blind Phase 2b clinical trial evaluating the efficacy and safety of two dose levels of zetomizomib in patients with active LN. Target enrollment is 279 patients randomly assigned (1:1:1) to receive 30 mg zetomizomib, 60 mg zetomizomib, or placebo subcutaneously once weekly for 52 seconds, in addition to standard background therapy. week. Background therapy may, but is not required to, include standard induction therapy. During the first 16 weeks, the dose of corticosteroids will be forced to be tapered to 5 mg or less per day. End-of-treatment assessment will be conducted at Week 53. The primary efficacy endpoint was the proportion of patients who achieved complete renal response (CRR) at week 37, including a urine protein to creatine ratio (UPCR) of 0.5 or less who did not receive rescue or contraindicated drugs.
About Kezar Life Sciences
Kezar Life Sciences is a clinical-stage biopharmaceutical company discovering and developing novel treatments for immune-mediated and oncological diseases. The company is pioneering first-in-class small molecule therapeutics that leverage master regulators of cellular function to inhibit multiple disease drivers with a single, powerful target. Zetomipzomib, its lead development asset, is a selective immunoproteasome inhibitor that has completed Phase 2 clinical trials in lupus nephritis. The product candidate also has the potential to treat a variety of chronic immune-mediated diseases. KZR-261 is the first anti-cancer clinical candidate on the company’s platform targeting the Sec61 translocon and protein secretion pathway. An open-label, dose-escalation Phase 1 clinical trial of KZR-261 is ongoing to evaluate safety, tolerability and preliminary tumor activity in solid tumors. For more information, visit www.kezarlifesciences.com and follow us on LinkedIn, Facebook, Twitter and Instagram.
About Everest Pharmaceuticals
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative medicines and vaccines to address critical unmet medical needs of patients in Asian markets. Everest Medicines’ management team has deep expertise and extensive experience in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations from leading global pharmaceutical companies and local Chinese pharmaceutical companies. Everest Medicines has built a portfolio of potentially global first-in-class or first-in-class molecules, many of which are in late-stage clinical development. The company’s therapeutic areas of interest include renal disease, infectious diseases, mRNA platforms and autoimmune diseases. For more information, please visit their website at www.everestmedicines.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “could,” “should,” “expect,” “believe,” “potential” and similar expressions (as well as other words or expressions that refer to future events, conditions or circumstances ) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that may result in Kezar’s clinical development plans , future results or performance could differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the potential payment and receipt of milestone payments and royalties, clinical trial collaborations and The development of zetomizomib in other indications, statements about the potential acceleration of clinical trial enrollment, the design, initiation, timing, scope and results of clinical trials, the expected therapeutic effects of Kezar’s product candidates and their ability to address unmet medical needs capabilities, the regulatory development and potential commercialization of Kezar’s product candidates and the likelihood of Kezar’s product candidates receiving regulatory approval. Many factors could cause differences between current expectations and actual results, including unexpected safety profiles observed during clinical studies or effectiveness data, difficulties in enrolling and conducting clinical trials, disputes or failure to perform under collaboration and licensing agreements, changes in anticipated or existing competition, changes in the regulatory environment, uncertainty and timing of the regulatory approval process, and the unexpected litigation or other disputes. Other factors that could cause actual results to differ from those expressed or implied by the forward-looking statements in this press release are discussed in Kezar’s filings with the Securities and Exchange Commission, including the “risk factors” contained therein. Except as required by law, Kezar disclaims any obligation to update any forward-looking statements contained herein to reflect changes in expectations, even if new information becomes available.
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