Inozyme Pharma Appoints Kevin B. Johnson, Ph.D., MBA, as Senior Vice President, Regulatory Affairs
Inozyme Pharma (Nasdaq: INZY) announced the appointment of Dr. Kevin B. Johnson as senior vice president of regulatory affairs. Dr. Johnson, who has over 25 years of experience in global regulatory strategies for rare diseases, will spearhead Inozyme's regulatory initiatives. His previous roles include senior vice president at Magenta Therapeutics and head of regulatory affairs at IMARA Inc., where he achieved key designations for orphan diseases. Inozyme focuses on developing treatments for rare metabolic diseases linked to mineralization disorders, particularly targeting ENPP1 and ABCC6 deficiencies.
- Dr. Johnson's extensive experience in regulatory affairs enhances leadership.
- Potential for improved regulatory strategies given his past successes in rare disease approvals.
- Concerns about continuity and potential gaps in experience during the transition.
Dr. Johnson Brings More Than 25 Years of Experience in Developing and Implementing Global Regulatory and Clinical Development Strategies from Preclinical Through Product Approval
BOSTON, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY), a rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced the appointment of Kevin B. Johnson, Ph.D., MBA, as senior vice president, regulatory affairs, effective immediately.
Dr. Johnson brings to Inozyme more than 25 years of experience in developing and implementing global regulatory and clinical development strategies for rare diseases across entire product development lifecycles from preclinical through clinical development and ultimately to product approval for a variety of drugs, biologics, combination products and cell/gene therapies. Dr. Johnson will be responsible for leading Inozyme’s global regulatory strategy.
“We are thrilled to have Kevin join the Inozyme leadership team during this period of steady execution and as we prepare to enter clinical development,” said Axel Bolte, MSc, MBA, co-founder, president and chief executive officer of Inozyme Pharma. “Kevin is a talented regulatory affairs executive with deep experience in rare diseases and I look forward to Kevin’s contributions in helping Inozyme meet the needs of underserved patient communities.”
Dr. Johnson joins Inozyme from Magenta Therapeutics, Inc., where he served as the senior vice president, head of regulatory and quality, and led global strategy for a portfolio of biologics. Prior to that, he served as senior vice president, head of regulatory affairs, quality and pharmacovigilance at IMARA Inc., during which time the company received several regulatory designations for orphan diseases such as sickle cell disease and beta-thalassemia. Before IMARA, Dr. Johnson led global regulatory strategies at Vtesse (later acquired by Sucampo), addressing ultra-rare diseases such as Niemann-Pick disease type C under Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and Promising Innovative Medicine designation from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). Dr. Johnson also served as the director, global regulatory affairs for rare diseases and gene therapies at GlaxoSmithKline, working on the international regulatory team for the European approval of the gene therapy Strimvelis® for ADA-SCID, and which team subsequently received Regenerative Medicine Advanced Therapy (RMAT) designation for a retinal gene therapy product.
“Based on the compelling science and preclinical research conducted with INZ-701, Inozyme has the potential to help patients with devastating and debilitating rare metabolic diseases who currently lack effective treatment options,” said Dr. Johnson. “I am excited to join Inozyme at such an important time in the company’s growth trajectory, and I look forward to contributing to Inozyme’s success.”
Dr. Johnson holds a Ph.D. in Neurobiology from the University of North Carolina School of Medicine, an MBA from the Kenan-Flagler School of Business at the University of North Carolina, and a B.S. in Chemistry from the University of South Florida. Dr. Johnson also holds a Regulatory Affairs Certification (RAC) credential from the Regulatory Affairs Professional Society.
About Inozyme Pharma
Inozyme Pharma is a rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are pursuing the development of therapeutics to address the underlying causes of these debilitating diseases. It is well established that two genes, ENPP1 and ABCC6, play key roles in a critical mineralization pathway and that defects in these genes lead to abnormal mineralization. We are initially focused on developing a novel therapy to treat the rare genetic diseases of ENPP1 and ABCC6 deficiencies.
Inozyme Pharma was founded in 2017 by Joseph Schlessinger, Ph.D., Demetrios Braddock, M.D., Ph.D., and Axel Bolte, MSc, MBA, with technology developed by Dr. Braddock and licensed from Yale University. For more information, please visit www.inozyme.com.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to our research and development programs. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the Company’s ability to successfully resolve the clinical hold with regard to its planned Phase 1/2 clinical trial of INZ-701 for ENPP1 deficiency; obtain and maintain necessary approvals from the FDA and other regulatory authorities; continue to advance its product candidates in preclinical studies and clinical trials; replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials; obtain, maintain and protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the Company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.
Investors:
Brian Luque, Director, Investor Relations
(951) 206-1200
ir@inozyme.com
Media:
Alex Van Rees, SmithSolve
(973) 442-1555 ext. 111
alex.vanrees@smithsolve.com
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