AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced the appointment of Kim Raineri, as chief manufacturing and technology officer. He brings deep global experience in the cell and gene therapy industry, with a distinguished track record of innovation and implementation of Good Manufacturing Practices (GMP).
AVROBIO’s founding chief manufacturing and technology officer, Kim Warren, Ph.D., will be retiring at the end of July. Among many other accomplishments, she led the development of plato®, the company’s proprietary gene therapy platform designed to bring gene therapy to patients worldwide through an efficient, automated, closed manufacturing system developed to be rapidly deployed to contracted manufacturing sites.
“We have made it a priority to build leadership in gene therapy manufacturing by integrating and optimizing pioneering technologies as part of our plato platform. As we continue to implement our global clinical trials and prepare for eventual commercial scale, we are delighted to bring Kim Raineri on board. His expertise in global GMP for cell and gene therapy will be highly valuable in keeping AVROBIO at the forefront of this industry,” said Geoff MacKay, AVROBIO’s president and CEO. “I also would like to thank Kim Warren for her integral contributions to AVROBIO these past five years. As one of my co-founders, Kim has played a key role in building the company and establishing plato as an unrivaled lentiviral gene therapy platform.”
“I am thrilled to join AVROBIO, a leader in lentiviral gene therapy and a true pioneer in driving manufacturing advances that address the gene therapy field’s need for faster, more scalable and more automated production,” said Raineri. “The AVROBIO team has created a state-of-the-art gene therapy platform and is clearly committed to continuous innovation on behalf of the patient communities they strive to serve. I am excited to contribute to that work.”
Raineri has broad, global experience in GMP operations, including in the cell and gene therapy, biologics and medical device spaces. Prior to joining AVROBIO, he served as the vice president of operations for Nikon CeLL innovation Co., Ltd, a Japanese contract development and manufacturing organization. During his tenure, he established the company as the preferred provider of custom process development and manufacturing services for cell and gene therapy products in the Japanese market. Previously, Raineri held management positions at Lonza, serving as the business director for the cell therapy contract manufacturing operations in Singapore for five years, and prior to that as director of operations at Lonza’s Maryland facilities. Raineri was also previously the senior manager of the Tissue Processing Lab at CryoLife Inc. He holds a B.S. from the University of Miami and an MBA from Kennesaw State University.
Our vision is to bring personalized gene therapy to the world. We aim to halt or reverse disease throughout the body by driving durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our clinical-stage programs include Fabry disease, Gaucher disease and cystinosis and we also are advancing a preclinical program in Pompe disease. AVROBIO is powered by the plato® gene therapy platform, our foundation designed to scale gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario. For additional information, visit avrobio.com, and follow us on Twitter and LinkedIn.
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 expected benefits from the appointment of Mr. Raineri to the position of chief manufacturing and technology officer, the expected benefits, timing and results of our implementation of the plato platform in our clinical trials and gene therapy programs, as well as future innovations to our plato platform and other gene therapy manufacturing technologies.
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 preclinical or 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 development timeline 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, 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.
Christopher F. Brinzey
Westwicke, an ICR Company