Shares of Kezar Life Sciences Inc. (KZR) have gained nearly 63% from their yearly-low of $2.36, recorded on November 18, 2019, but are still nowhere near the 52-week high of $22.50 registered on February 21, 2019.
Kezar is a clinical-stage biotechnology company developing novel therapeutics for autoimmune disease and cancer. The Company’s lead drug candidate is KZR-616 a selective inhibitor of immunoproteasome that plays a crucial role in the immune system.
KZR-616 is under a phase Ib/II study in systemic lupus erythematosus patients with and without nephritis, dubbed MISSION. In the study, KZR-616 is administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).
In the phase Ib portion of the MISSION study, investigators have reported that there has been good tolerability with KZR-616, with improving disease activity in the patients, according to the Company.
Data from an interim analysis of the MISSION study is expected in the first half of 2021, with final data anticipated in the second half of next year.
According to a new study by Acumen Research and Consulting, the global Systemic Lupus Erythematosus Market size is estimated to reach US$2.7 billion by 2026, reflecting a CAGR of 7.0% from 2018 to 2026.
Bristol-Myers, Aurinia Pharma, GlaxoSmithKline, Roche, Mylan, Eli Lily, Sanofi, Pfizer and Merck are some of the big players in the Lupus drug space. During 2014 and 2019, there were 15 licensing and asset acquisition deals involving the lupus drugs, says a report by ResearchAndMarkets.com.
KZR-616 is also being studied in a phase II study in patients with active Autoimmune Hemolytic Anemia or Immune Thrombocytopenia, dubbed MARINA. This trial is designed to enroll 40 patients with either AIHA or ITP, with interim data expected in the fourth quarter of 2020 and final data in mid-2021.
Another study that merits mention is a phase II study of KZR-616 in patients with active polymyositis or dermatomyositis, dubbed PRESIDIO.
Besides the clinical programs, Kezar Life also has a compound in preclinical testing by the name KZR-261.
The Company plans to file an investigational New Drug Application for a phase I study of KZR-261 in solid tumors in the first quarter of 2021.
As of September 30, 2019, the Company’s cash, cash equivalents, and marketable securities totaled $85.2 million. Kezar received gross proceeds of $56.8 million from a public offering that closed on February 4, 2020.
KZR has traded in a range of $2.36 to $22.50 in the last 1 year.
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