Inozyme Pharma Appoints Kurt Gunter, M.D., as Chief Medical Officer
BOSTON, June 07, 2022 – Inozyme Pharma (Nasdaq: INZY) announced the appointment of Dr. Kurt Gunter as Chief Medical Officer. Dr. Gunter brings over 30 years of experience in regulatory affairs and clinical development, previously serving at Athenex and Kuur Therapeutics. He will lead Inozyme's clinical strategy for INZ-701, currently in Phase 1/2 trials for ENPP1 and ABCC6 Deficiencies. These are serious rare diseases with no approved therapies, making INZ-701 a vital potential treatment. His expertise is expected to enhance Inozyme's efforts to address unmet medical needs.
- Appointment of Kurt Gunter as CMO brings significant expertise in regulatory affairs and clinical development.
- INZ-701 is in Phase 1/2 clinical trials, aimed at treating rare diseases with no current therapies.
- Concerns about the ability to successfully advance INZ-701 through later stages of clinical trials.
- Potential risks in obtaining necessary FDA approvals for INZ-701 and managing the associated costs.
BOSTON, June 07, 2022 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of abnormal mineralization, today announced the appointment of Kurt Gunter, M.D., as chief medical officer. Dr. Gunter, who most recently served as chief medical officer, cell therapy, and head of regulatory affairs at Athenex, brings to Inozyme over 30 years of expertise in regulatory affairs, clinical development, and government relations.
“It is a pleasure to welcome Kurt to the Inozyme team to lead Inozyme’s clinical development and regulatory strategy,” said Axel Bolte, MSc, MBA, Inozyme’s co-founder, president, and chief executive officer. “Kurt’s experience across the entirety of the drug development process will be invaluable as we advance INZ-701 in our ongoing Phase 1/2 clinical trials in patients with ENPP1 Deficiency and ABCC6 Deficiency and prepare for our later-stage studies.”
“ENPP1 Deficiency and ABCC6 Deficiency represent two devastating rare diseases for which there are currently no approved therapies,” said Dr. Gunter. “I firmly believe that INZ-701 could serve as a much-needed intervention for patients suffering from these highly underserved areas, and I look forward to contributing to Inozyme’s mission of addressing these urgent unmet needs.”
Prior to Athenex, Dr. Gunter served as chief medical officer at Kuur Therapeutics (formerly Cell Medica), where he headed the medical affairs, clinical operations, and regulatory affairs departments. He also previously held positions of increasing responsibility at Hospira, Inc., including vice president, clinical development, and global medical director for hematology-oncology. Before Hospira, Dr. Gunter held positions at Zymequest, ViaCell, and Transkaryotic Therapies, Inc. While at Transkaryotic Therapies, Inc., he played an integral role in the global regulatory strategy for Replagal, an enzyme replacement therapy (ERT) approved for Fabry disease. He also previously served as president of the International Society for Cellular Therapy (ISCT), where he played a worldwide leadership role in promoting understanding of the clinical, regulatory, manufacturing, and marketing requirements for the successful development of cell and gene therapies.
Prior to his biotech career, Dr. Gunter worked at the U.S. Food and Drug Administration (FDA) as a medical officer in the Center for Biologics and was appointed acting deputy director of the Division of Cell and Gene Therapy within the Center for Biologics Evaluation and Research. He also served for five years on the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee.
Dr. Gunter earned his M.D. from the University of Kansas School of Medicine, and also has a B.S. in Biological Sciences, with Distinction, from Stanford University. His postdoctoral training included Johns Hopkins University and the U.S. National Institutes of Health.
About Inozyme Pharma
Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage 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, INZ-701, to treat the rare genetic diseases of ENPP1 and ABCC6 Deficiencies. INZ-701 is currently in Phase 1/2 clinical trials for the treatment of ENPP1 Deficiency and ABCC6 Deficiency.
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 the initiation and timing of our clinical trials, and the potential benefits of INZ-701. 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 initiate and conduct its ongoing and planned Phase 1/2 clinical trials of INZ-701 for ENPP1 Deficiency and ABCC6 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 in the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, 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.
Contacts
Investors:
Inozyme Pharma
Stefan Riley, Director of Investor Relations
857-330-8871
stefan.riley@inozyme.com
Media:
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Matt Pera
973-886-9150
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