- Mr. Levine adds valuable experience to the leadership team as Immunovant accelerates the development of batoclimab with the expected initiation of three pivotal trials in 2022
NEW YORK, Jan. 25, 2022 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, announced the appointment of Mark Levine as Chief Legal Officer.
“We are extremely pleased to welcome Mark Levine as Immunovant’s Chief Legal Officer,” said Pete Salzmann, M.D., Chief Executive Officer. “Mark’s broad legal experience at biopharmaceutical companies ranging from early-stage development through commercialization will enhance our existing capabilities as we plan to initiate pivotal trials for batoclimab in 2022.”
Mr. Levine joins Immunovant with more than 20 years of legal experience including negotiating mergers, acquisitions, and divestitures; managing licensing agreements and partnerships; and providing counsel to optimize development and commercialization. Mr. Levine most recently served as General Counsel and Corporate Secretary of Flexion Therapeutics, Inc., a commercial stage biopharmaceutical company, where he was a member of the executive committee and was responsible for overseeing all legal and compliance affairs related to Flexion’s launch of ZILRETTA® in the United States in 2017 and building its pipeline. Mr. Levine’s tenure at Flexion culminated in the acquisition of the company by Pacira BioSciences, Inc. in late 2021. Mr. Levine previously served as General Counsel and Corporate Secretary at Minerva Neurosciences, Inc., a publicly traded development stage biopharmaceutical company, and as Associate General Counsel at Clinical Data, Inc., a biopharmaceutical company acquired by Forest Laboratories, Inc. (now AbbVie) after the United States Food and Drug Administration (FDA)’s approval of the company’s VIIBRYD® in 2011.
Immunovant recently announced that it plans to initiate a Phase 3 study for batoclimab in myasthenia gravis (MG) in the first half of calendar year 2022, and also plans to resume development of batoclimab in thyroid eye disease (TED) and warm autoimmune hemolytic anemia (WAIHA). In addition to MG, TED and WAIHA, the Company plans to announce two new indications, which would bring the total number of indications under study to five. Of the five indications being studied, three (including MG) are expected to be initiated as pivotal trials in 2022.
“Batoclimab’s potential to meaningfully improve the lives of people with a wide range of autoimmune diseases drew me to this opportunity,” said Mr. Levine. “I’m also excited to join a talented executive team and a dynamic company culture as clinical trials are expected to resume.”
Mr. Levine holds a B.A. from Binghamton University, SUNY, and a J.D. from Washington University School of Law in St. Louis.
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases. Immunovant is developing batoclimab, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.
Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include Immunovant’s plan to initiate a Phase 3 study for batoclimab in MG in the first half of calendar year 2022; Immunovant’s plan to resume development of batoclimab in TED and WAIHA; Immunovant’s plan to initiate three pivotal trials for batoclimab in calendar year 2022; Immunovant’s plan to develop batoclimab across a broad range of autoimmune indications; Immunovant’s expectations regarding timing, the design and results of clinical trials of its product candidates and indication selections; and the potential benefits of batoclimab’s unique product attributes. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidate, including the timing of the commencement of additional clinical trials and resumption of current trials; Immunovant’s scientific approach, clinical trial design, indication selection and general development progress; future clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidate may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of the ongoing COVID-19 pandemic on Immunovant’s clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval and commercialization of its sole product candidate, batoclimab; Immunovant is at an early stage in development of batoclimab; and Immunovant will require additional capital to fund its operations and advance batoclimab through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s most recent Annual Report on Form 10-K, its Form 10-Q filed with the SEC on November 5, 2021, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
Tom Dorney, MS, MBA
Director, Investor Relations & Strategy
Immunovant, Inc.
info@immunovant.com
