Passage Bio Announces Gene Therapy Manufacturing Research and Development Site

Passage Bio Announces Gene Therapy Manufacturing Research and Development Site




Passage Bio Announces Gene Therapy Manufacturing Research and Development Site

– Company invests to build in-house capabilities to support advancement of pipeline –

– In combination with dedicated CGMP suite at Catalent, the new laboratory creates foundation for integrated AAV gene therapy manufacturing –

PHILADELPHIA, Dec. 16, 2020 (GLOBE NEWSWIRE) — Passage Bio, Inc. (Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders, today announced that it has entered into a long-term lease to support Chemistry, Manufacturing and Controls (CMC) laboratory operations for the company’s gene therapy programs. The new laboratory, slated to open in the second quarter of 2021 at the Princeton West Innovation Campus in Hopewell, New Jersey, will initially focus on state-of-the-art analytical capabilities, clinical assay development and validation, biomarker assay validation and clinical product testing to support both viral vector manufacturing and clinical development.

The opening of the CMC laboratory is a key component of Passage Bio’s strategy to expand its internal manufacturing capabilities to support its lead gene therapy programs as they move into the clinic and advance toward commercialization. The CMC laboratory complements the recent opening of Passage Bio’s dedicated CGMP manufacturing suite at Catalent. These investments provide the company with the foundation for an integrated manufacturing supply chain with robust capabilities to advance multiple gene therapy programs to support clinical trials worldwide.

“Investing in an in-house CMC lab puts us in greater control of our vector manufacturing and quality control processes as we advance our gene therapy product candidates into the clinic in 2021 and beyond,” said Bruce Goldsmith, Ph.D., president and chief executive officer of Passage Bio. “The opening of this lab will be another important step to assure we have the processes in place to support the continued development of our lead gene therapy products well into the future.”

Passage Bio has leased approximately 62,000 square feet of lab space at the Princeton West Innovation Campus which is intended to support analytics, process development, quality control and pilot manufacturing. The 1.2 million-square-foot, multi-purpose research and development and biologic/pharmaceutical manufacturing campus also provides Passage Bio with readily available expansion opportunities for additional lab space and CGMP manufacturing operations to support long-term growth in the company’s gene therapy pipeline programs. Passage Bio plans to expand its headcount with more than 20 new positions in 2021 at the new CMC lab.

Alex Fotopoulos, MSc., MBA, chief technical officer of Passage Bio, added, “State-of-the-art analytics are essential for optimizing vector production and characterizing the safety and efficacy of gene therapy products as we move from early to late-stage clinical development and eventually to commercial-scale production. The lab capability and infrastructure will enable us to apply and advance cutting-edge vector analytics, along with our partners at the Penn Gene Therapy Program, to propel our gene therapy programs forward.”

About Passage Bio

At Passage Bio (Nasdaq: PASG), we are on a mission to provide life-transforming gene therapies for patients with rare, monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve. Based in Philadelphia, PA, our company has established a strategic collaboration and licensing agreement with the renowned University of Pennsylvania’s Gene Therapy Program to conduct our discovery and IND-enabling preclinical work. This provides our team with access to a broad portfolio of gene therapy candidates and future gene therapy innovations that we then pair with our deep clinical, regulatory, manufacturing and commercial expertise to rapidly advance our robust pipeline of optimized gene therapies into clinical testing. As we work with speed and tenacity, we are always mindful of patients who may be able to benefit from our therapies. More information is available at www.passagebio.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995, including, but not limited to: our expectations about timing and execution of anticipated milestones, including our planned IND submissions, initiation of clinical trials and the availability of clinical data from such trials; our expectations about our collaborators’ and partners’ ability to execute key initiatives; our expectations about manufacturing plans and strategies; our expectations about cash runway; and the ability of our lead product candidates to treat the underlying causes of their respective target monogenic CNS disorders. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop and obtain regulatory approval for our product candidates; the timing and results of preclinical studies and clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; failure to protect and enforce our intellectual property, and other proprietary rights; our dependence on collaborators and other third parties for the development and manufacture of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions caused by the coronavirus pandemic; and the other risks and uncertainties that are described in the Risk Factors section in documents the company files from time to time with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. Passage Bio undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

For further information, please contact:

Passage Bio Investors:

Sarah McCabe and Zofia Mita

Stern Investor Relations, Inc.

212-362-1200

sarah.mccabe@sternir.com

Zofia.mita@sternir.com

Passage Bio Media:

Gwen Fisher

Passage Bio

215-407-1548

gfisher@passagebio.com