- Built Internal GMP Commercial Process and Manufacturing Platform and Scaled HEK293 Suspension System to 2,000L Under His Leadership -
BEDFORD, Mass., April 12, 2021 – Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today that Tim Kelly has been promoted to Chief Operating Officer, effective immediately. Previously, Mr. Kelly held the role of Chief Technical Operations Officer and led the construction of the Company’s internal 25,000-square-foot GMP manufacturing facility, which was completed in 12 months from design to operation. As one of the first companies to scale to a 2,000-liter bioreactor with a HEK293 serum-free suspension system, Homology’s commercial scale process and platform gives the Company the ability to produce large scale volumes to support its gene therapy and editing programs, and can be further leveraged to target larger disease areas.
“From the beginning, Tim was a major driver behind the strategic decision to invest in developing our process and internal manufacturing capabilities, including realizing the value of operating under the same roof as our research and process development labs,” stated Arthur Tzianabos, Ph.D., President and Chief Executive Officer of Homology Medicines. “Tim’s more than 20 years of technical knowledge and business operations experience has been key to progressing our dual gene therapy and editing platform, and we look forward to his broader contributions to our organization as we continue to advance our mission to bring genetic medicines to patients.”
Under his leadership, Homology has attracted and grown a highly experienced technical operations team, some of whom worked alongside Mr. Kelly in developing the first commercially approved, single-use bioreactor manufacturing system many years ago while at Shire plc. This experience, coupled with Tim’s strategic vision, enabled the rapid development and optimization of Homology’s “plug and play” platform that currently serves all programs, regardless of the modality or transgene. With 3,500 liters of total capacity, Homology is advancing its Phase 2 pheNIX gene therapy clinical trial, for which it expects to report initial data by the end of this year, and plans to initiate two other clinical programs, including its first gene editing trial.
Mr. Kelly is an industry leader with a successful track record that spans senior roles at Shire plc, Sarepta Therapeutics, Inc., Biogen Idec and UCB S.A. He has been featured in many industry articles and panels and plans to participate in the upcoming 5th Annual Chardan Genetic Medicines Manufacturing Summit taking place on Tuesday, April 27 at 1:00 p.m. ET, where he will present on Homology’s manufacturing process and platform.
About Homology Medicines, Inc.
Homology Medicines, Inc. is a clinical-stage genetic medicines company dedicated to transforming the lives of patients suffering from rare genetic diseases with significant unmet medical needs by curing the underlying cause of the disease. Homology’s proprietary platform is designed to utilize its human hematopoietic stem cell-derived adeno-associated virus vectors (AAVHSCs) to precisely and efficiently deliver genetic medicines in vivo either through a gene therapy or nuclease-free gene editing modality across a broad range of genetic disorders. Homology has a management team with a successful track record of discovering, developing and commercializing therapeutics with a particular focus on rare diseases. The Company’s intellectual property covers its family of 15 AAVHSCs. Homology believes that its compelling preclinical data, scientific expertise, product development strategy, manufacturing capabilities and intellectual property position it as a leader in the development of genetic medicines. For more information, please visit www.homologymedicines.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential, safety, efficacy, and regulatory and clinical progress of our product candidates; plans and timing for the release of clinical data and for the initiation of additional clinical programs; our beliefs regarding our manufacturing capabilities; our position as a leader in the development of genetic medicines; and participation in upcoming presentations and conferences. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our business and operations, including our preclinical studies and clinical trials, and on general economic conditions; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; failure to identify additional product candidates and develop or commercialize marketable products; the early stage of our development efforts; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the capabilities of our manufacturing facility; risks relating to the regulatory approval process; our product candidates may cause serious adverse side effects; initial, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; failure to obtain U.S. or international marketing approval; ongoing regulatory obligations; effects of significant competition; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; failure to attract, retain and motivate qualified personnel; the possibility of system failures or security breaches; risks relating to intellectual property and significant costs as a result of operating as a public company. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.