AVROBIO Announces the Appointment of Sean O’Bryan as Chief Regulatory Officer

Rhea-AI Summary

AVROBIO (Nasdaq: AVRO), a clinical-stage gene therapy company, has appointed Sean O’Bryan as its new Chief Regulatory Officer. O’Bryan brings over 30 years of regulatory experience in the biotech sector, most recently at Freeline Therapeutics. His appointment is expected to enhance AVROBIO's clinical programs, particularly in lysosomal disorders such as cystinosis and Gaucher disease. CEO Geoff MacKay expressed confidence in O’Bryan's expertise to accelerate AVROBIO's mission of delivering personalized gene therapies.

Positive

• Appointment of Sean O’Bryan as Chief Regulatory Officer brings over 30 years of relevant experience.
• O’Bryan's expertise is expected to enhance clinical programs in lysosomal disorders, potentially improving regulatory approvals.

Negative

• Concerns regarding continuity and experience gaps raised by the leadership change.

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a shared purpose to free people from a lifetime of genetic disease, today announced the appointment of Sean O’Bryan as chief regulatory officer. Sean brings a wealth of experience in regulatory strategy and product development to AVROBIO, as well as keen insight into the field of cell and gene therapy, where he has spent most of his career.

“We are delighted to bring Sean O’Bryan on board as we advance multiple programs in lysosomal disorders. His leadership and deep understanding of the cell and gene therapy space will be highly valuable as we progress our clinical programs in cystinosis and Gaucher disease and move our other indications forward,” said Geoff MacKay, AVROBIO’s president and chief executive officer.

O’Bryan has more 30 years of experience leading regulatory efforts in the biotech industry. He joins AVROBIO from Freeline Therapeutics, where he served as the senior vice president and head of Global Regulatory Affairs. During his tenure, O’Bryan directed the development of gene therapies from preclinical to clinical and managed CMC strategy generation and execution as well as negotiations and approvals with global agencies.

“I am thrilled to land at AVROBIO and join this incredibly talented and dedicated team,” said O’Bryan. “I look forward to leveraging my product development and regulatory expertise to make AVROBIO’s vision – to bring personalized gene therapy to the world – a reality for the patients and families we serve.”

Previously, O’Bryan was senior vice president, head of Regulatory Affairs & Quality Assurance at Axovant (now Sio Gene Therapies), leading all regulatory and quality work for multiple vector-based gene therapy programs and serving as project lead for the lysosomal disease programs. He also advanced the regulatory process for multiple cell and gene therapy programs in his previous roles as vice president, head of Regulatory Affairs and Quality Assurance at Lysogene, senior director of Regulatory Affairs and head of Regulatory CMC at bluebird bio and director, Regulatory Affairs at Sanofi/Genzyme. O’Bryan holds a B.S. from Boston University.

About AVROBIO
Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of therapeutic protein, even in hard-to-reach tissues and organs including brain, muscle and bone. AVROBIO’s pipeline is powered by our industry-leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. It includes clinical programs in cystinosis and Gaucher disease type 1, as well as preclinical programs in Gaucher disease type 3, Hunter syndrome and Pompe disease. We are headquartered in Cambridge, Mass. For additional information, visit avrobio.com, and follow us on Twitter and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “aims,” “anticipates,” “believes,” “could,” “designed to,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding the potential benefits from the appointment of Sean O’Bryan to the position of chief regulatory officer, statements regarding our business strategy for and the potential therapeutic benefits of our prospective product candidates, the anticipated overall safety profile of our product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, clinical trial results, product approvals and regulatory pathways, anticipated benefits of our gene therapy platform including potential impact on our commercialization activities, and the expected benefits and results of our implementation of the plato® platform in our clinical trials and gene therapy programs. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early-stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Any forward-looking statements in this press release are based on AVROBIO’s current expectations, estimates and projections about our industry as well as management’s current beliefs and expectations of future events only as of today 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, the risk that any one or more of AVROBIO’s product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned clinical trials of AVROBIO or our collaborators, the risk that AVROBIO may not successfully recruit or enroll a sufficient number of patients for our clinical trials, the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato® platform, the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIO’s product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, risks relating to clinical trial and business interruptions resulting from the COVID-19 outbreak or similar public health crises, including that such interruptions may materially delay our enrollment and development timelines and/or increase our development costs or that data collection efforts may be impaired or otherwise impacted by such crises, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIO’s actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled “Risk Factors” in AVROBIO’s most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties and other important factors in AVROBIO’s subsequent filings with the Securities and Exchange Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220201005131/en/

Investor Contact:

Christopher F. Brinzey

Westwicke, an ICR Company

339-970-2843

chris.brinzey@westwicke.com



Media Contact:

Kit Rodophele

Ten Bridge Communications

617-999-9620

krodophele@tenbridgecommunications.com

Source: AVROBIO, Inc.

FAQ

What is the significance of Sean O’Bryan's appointment to AVROBIO?

Sean O’Bryan's appointment as Chief Regulatory Officer is significant as he brings over 30 years of experience in regulatory strategy and product development, which could strengthen AVROBIO's clinical programs.

How might Sean O’Bryan's leadership impact AVROBIO's clinical programs?

O’Bryan's leadership is expected to enhance AVROBIO's clinical programs, particularly in treating lysosomal disorders, by leveraging his extensive regulatory expertise.

What experience does Sean O’Bryan have prior to joining AVROBIO?

Before joining AVROBIO, O’Bryan was the Senior Vice President and Head of Global Regulatory Affairs at Freeline Therapeutics, directing gene therapy development from preclinical to clinical stages.

What are some potential challenges AVROBIO might face after this management change?

Potential challenges include continuity issues and experience gaps due to the leadership change, which could impact the progression of clinical trials and regulatory approvals.

What is AVROBIO's goal in gene therapy?

AVROBIO aims to deliver personalized gene therapies to prevent, halt, or reverse genetic diseases with a single treatment, utilizing their plato® gene therapy platform.