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Voyager receives $ 30 million upfront with potential option exercise fees and milestone payments of up to $ 600 million plus royalties based on product sales
Pfizer Receives Transgene-Specific Access to Voyager’s New AAV Capsids with Improved Blood-Brain Barrier Penetration and Heart Muscle Tropism for Potential Use with Two Transgenes
CAMBRIDGE, Mass., October 6, 2021 (GLOBE NEWSWIRE) – Voyager Therapeutics, Inc. (Nasdaq: VYGR), a gene therapy company developing life-changing treatments and adeno-associated virus (AAV) platform technologies generation, today announced an agreement whereby Pfizer Inc (NYSE: PFE) may exercise options to license new capsids generated from Voyager’s RNA-based TRACERMT (Tropism Redirection of AAV by Cell-type-specific Expression of RNA) as part of Pfizer’s efforts to develop, manufacture and commercialize gene therapies, using two undisclosed transgenes to treat certain neurological and cardiovascular diseases.
“This transaction highlights the potential of our TRACER platform to identify novel AAV capsids that target desired cells and tissues with greater specificity at lower doses and with less off-target risk than serotypes. Conventional AAVs, ”said Michael Higgins, Voyager’s interim CEO. “We believe our TRACER platform has the ability to produce not only enhanced penetrating capsids of the blood-brain barrier, but also new capsids with improved tropisms in a variety of tissues and cell types, offering the promise to unleash the full potential of gene therapies for a wide range of diseases with unmet medical needs.
“Our collaboration with Voyager will provide Pfizer with access to additional AAV capsids that could help further advance our advanced gene therapy portfolio,” said Seng Cheng, Ph.D., senior vice president and chief scientific officer of the Pfizer Rare Disease Research Unit. “We are impressed with Voyager’s results to date and excited about the potential to use these new capsids to help accelerate the development of new treatment options for patients living with certain neurological and cardiovascular diseases. “
The proprietary AAV capsids derived from Voyager’s TRACER platform demonstrated superior blood-brain barrier penetration, increased heart muscle tropism, and increased transgene expression in target tissues compared to conventional AAV capsids as measured in non-human primates (PNH). Voyager presented data to the 24e American Society of Gene and Cell Therapy annual meeting for a capsid candidate demonstrating more than 1,000 times greater transgenic expression than conventional AAV9 in a wide range of brain regions when administered intravenously in NHPs. The presented results also included another capsid candidate showing significantly improved cardiac muscle transduction and dorsal root ganglia de-targeting compared to conventional AAV9. Voyager performs further screening with its TRACER platform to identify additional proprietary AAV capsids targeting multiple tissue and cell types for use in gene therapies to treat a wide range of diseases.
Under the terms of the agreement, Pfizer will have the right to evaluate selected new capsids for the central nervous system and cardiac tropisms from Voyager’s TRACER platform and to exercise capsid licensing options for one. exclusive use in Pfizer’s development of AAV gene therapies incorporating two undisclosed transgenes. These transgenes will be distinct from those planned for Voyager’s internal pipeline. Voyager will retain worldwide rights to all licensed capsids for use with other transgenes and to all other applications of its TRACER technology.
Voyager will receive $ 30 million upfront and is entitled to receive up to $ 20 million in exercise fees for two options, exercisable by Pfizer within 12 months of signing. In addition, Voyager will be eligible to earn up to $ 580 million in development, regulatory and commercial milestones associated with licensed products incorporating the two undisclosed Pfizer transgenes as well as a licensed Voyager capsid. Voyager is also eligible to receive tiered, mid to high single-digit royalties based on net sales of Pfizer products incorporating the licensed capsids.
About the TRACER AAV Capsid Discovery Platform
Voyager’s TRACER System is a widely applicable RNA-based functional screening platform that enables rapid in vivo evolution of AAV capsids with enhanced tropisms and cell and tissue-specific transduction properties in several species. , including non-human primates (PNH). Initial data from the first of many libraries selected in NHPs demonstrated that the capsid-exclusive variants efficiently penetrated the blood-brain barrier and allowed widespread biodistribution and transduction of several regions of the brain. Separate results demonstrated the ability of certain capsids to transduce heart muscle and de-target dorsal root ganglia. Voyager is conducting additional capsid campaigns derived from AAV9 and other capsid serotypes to identify new AAV vectors optimized for specific therapeutic applications.
About Voyager Therapeutics
Voyager Therapeutics (Nasdaq: VYGR) is leading the next generation of AAV gene therapy to unlock the potential of technology to treat devastating diseases. The proprietary capsids born out of the company’s TRACER screening platform fuel a rich start-up pipeline of new and second-generation programs and can elevate the field to overcome the limitations of conventional gene therapy vectors in neurological and neurological disorders. ‘other therapeutic areas. voyageherapeutics.com LinkedIn Twitter
Forward-looking statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may”, “could”, “will”, “should”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “Definitely”, “plan”, “intention”, “future”, “potential” or “continue” and other similar expressions are intended to identify forward-looking statements.
For example, all of Voyager’s claims regarding Voyager’s ability to continue to identify and develop proprietary capsids from its TRACER AAV screening platform; Voyager’s ability to identify and develop proprietary capsids from its TRACER AAV screening platform with increased transgene expression, increased blood brain barrier penetration and increased biodistribution compared to conventional AAV9 capsids; Voyager’s ability to use its new proprietary capsids in its own product development programs; Voyager’s ability to attract parties to license its new proprietary capsids or to participate with Voyager in research and development collaborations using its new proprietary capsid; Voyager’s ability to advance its AAV-based gene therapy programs; Voyager’s ability to fulfill its obligations under its license option agreement with Pfizer; Voyager’s right to receive upfront fees, milestones and royalties from Pfizer under the license option agreement; Voyager’s ability to enter into new partnerships or collaborations; and Voyager’s ability to generate sufficient cash resources to enable it to continue to identify and develop proprietary capsids from its TRACER AAV screening platform are forward-looking.
All forward-looking statements are based on estimates and assumptions by Voyager’s management which, while Voyager believes these forward-looking statements to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those Voyager expected. These risks and uncertainties include, among others, the severity and duration of the COVID-19 health crisis, the imposition of government controls and guidelines in the face of the COVID-19 health crisis, and the available financial and human resources. for Traveling to Manage COVID-19 Health. crisis; the continued development of various technology platforms, including Voyager’s TRACER platform; Voyager’s scientific approach and general development progress; the ability to attract and retain talented entrepreneurs and employees; the ability to create and protect intellectual property; sufficient liquidity; whether or when to exercise development, commercialization, licensing and other options under the Pfizer License Option Agreement and other collaborations; Voyager’s ability to negotiate and enter into licensing or collaborative agreements on terms acceptable to Voyager and third parties; and the availability or commercial potential of Voyager’s product candidates. These statements are also subject to a number of important risks and uncertainties which are described in Voyager’s most recent annual report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings. with the Securities and Exchange Commission. All information contained in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager assumes no obligation to publicly update or revise any such information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
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