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Adicet Bio Appoints Nancy Boman, M.D., Ph.D., as Senior Vice President and Chief Regulatory Officer
Rhea-AI Impact
(Low)
Rhea-AI Sentiment
(Very Positive)
Tags
management
Rhea-AI Summary
Adicet Bio, Inc. (NASDAQ: ACET) has appointed Nancy Boman, M.D., Ph.D., as Senior Vice President and Chief Regulatory Officer. Dr. Boman will lead the regulatory strategy to enhance Adicet's gamma delta T cell therapy pipeline, including the initiation of a pivotal program for ADI-001 in the first half of 2023 and an IND application for ADI-925 in the second half of 2023. With nearly 30 years of experience in regulatory affairs, Dr. Boman previously held key roles at Encoded Therapeutics and AveXis, overseeing successful marketing applications.
Positive
Appointment of Nancy Boman enhances regulatory leadership.
Dr. Boman's experience in oncology aligns with advancing pipeline programs.
Potential initiation of pivotal study for ADI-001 and IND for ADI-925 by mid-2023.
Negative
Regulatory approval processes are lengthy and uncertain, potentially delaying product launches.
REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today announced the appointment of Nancy Boman, M.D., Ph.D., as Senior Vice President and Chief Regulatory Officer. Dr. Boman will spearhead Adicet’s regulatory strategy to further advance existing and new pipeline opportunities for the Company’s gamma delta T cell platform.
“We are incredibly excited to welcome Nancy to the Adicet team,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “Her vast experience in successfully filing marketing applications for more than 15 products, including in hematologic malignancies, such as non-Hodgkin’s lymphoma, is perfectly aligned with our plan to initiate a potentially pivotal program for ADI-001 in the first half of 2023. Nancy’s leadership in building and expanding global regulatory operations particularly in the oncology field, including in solid tumors, is an asset to the team and positions us well as we expect to submit an IND application for ADI-925 in the second half of 2023 and potentially advance other pipeline programs, as disclosed in our recent R&D event, to regulatory submissions and clinical trials.”
“I am pleased to join the Adicet team during this pivotal time in the Company’s growth trajectory,” commented Dr. Boman, Senior Vice President and Chief Regulatory Officer of Adicet Bio. “With the positive updates on ADI-001 to date and an emerging preclinical pipeline of potentially best-in-class gamma delta T cell therapy product candidates, I look forward to supporting the team in bringing novel therapies to patients in need.”
Dr. Boman has nearly 30 years of industry experience in the biotech and pharmaceutical industry with expertise in clinical development, chemistry, manufacturing and controls management, and regulatory operations leading more than 15 drug marketing applications. She joins Adicet from Encoded Therapeutics, Inc., where, as a Chief Regulatory Officer, she built and oversaw all aspects of the regulatory department for its gene therapy candidates. Previously, Dr. Boman led the regulatory affairs practice as Chief Regulatory Officer at AveXis Inc. (now Novartis Gene Therapies), helping manage product candidate Zolgensma®, as well as expand the commercialization of adeno-associated virus-based innovative gene therapies. Prior to that she served as Senior Vice President, Regulatory Affairs and Pharmacovigilance at Alder BioPharmaceuticals, Inc., and has also held positions in regulatory affairs and clinical development at Cell Therapeutics, Inc., Genentech, Inc. and Amgen, Inc. Dr. Boman received her M.D. in Human Medicine, her Ph.D. in Biochemistry, and B.Sc. in General Science from The University of British Columbia.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs) and adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.
Forward-Looking Statements
This press release contains "forward-looking statements" of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to business and operations of Adicet. These forward-looking statements include, but are not limited to, express or implied statements regarding future plans and expectations for ADI-001 and Adicet’s preclinical programs; the anticipated timing for the initiation of a potentially pivotal study for ADI-001 and investigational new drug (IND) application for ADI-925; Adicet’s expected growth as a company; and the anticipated contribution of the members of Adicet’s executive team to the Company’s operations and progress.
Any forward-looking statements in this press release are based on management's current expectations and beliefs 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, including without limitation, the effect of COVID-19 on Adicet’s business and financial results, including with respect to disruptions to Adicet’s business operations and ability to raise additional capital; Adicet's ability to execute on its strategy, including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results from preclinical studies may not necessarily be predictive of the results of any future clinical studies; any future preclinical or clinical studies may fail to demonstrate adequate safety and efficacy of Adicet’s product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet's actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Adicet's most recent Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent filings with the SEC. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law.
Who is Nancy Boman and what is her role at Adicet Bio?
Nancy Boman, M.D., Ph.D., is the newly appointed Senior Vice President and Chief Regulatory Officer at Adicet Bio, responsible for leading the regulatory strategy for the company's gamma delta T cell therapies.
What impact will Nancy Boman's appointment have on Adicet Bio?
Her extensive experience in regulatory affairs, especially in oncology, is expected to strengthen Adicet's regulatory strategy and improve the chances of successful submissions for clinical trials.
What are the upcoming regulatory milestones for Adicet Bio?
Adicet plans to initiate a pivotal program for ADI-001 in the first half of 2023 and submit an IND application for ADI-925 in the second half of 2023.
