– AskBio Secures 100% Ownership of TAAV Manufacturing Solutions, SL to Manufacture AAV doggybone DNA (dbDNA) Technology from San Sebastian, Spain
– Touchlight to Commence Independent AAV dbDNA Manufacture Through Its Existing CDMO Operation in Hampton, United Kingdom
Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, and Touchlight, a biotechnology company pioneering enzymatic DNA production, have announced a revised structure to their former joint venture, Touchlight AAV.
Under the revised arrangement implemented on 1 February 2022, both parties benefit from co-exclusive rights to independently supply the Adeno-Associated Virus (AAV) market with doggybone DNA (dbDNA™) through their respective independently owned Contract Development and Manufacturing Organisations (CDMO).
Additionally, AskBio has secured 100 percent ownership of the San Sebastian manufacturing site for its production of research, clinical and commercial AAV dbDNA. It will be operated through the former Touchlight AAV organization, which will be rebranded and operate as TAAV, as part of the restructure. TAAV will retain its right to manufacture AAV dbDNA both for AskBio’s internal product development pipeline as well as continuing to provide AAV dbDNA to third-party customers from their new, recently completed state-of-the-art facility in San Sebastian, Spain.
Through the transaction, Touchlight regains co-exclusive rights to manufacture and sell its proprietary technology, dbDNA for AAV production.
Touchlight DNA Services, the CDMO arm of the Touchlight group, supplies services, development and GMP materials across viral vectors, cell therapy, mRNA and DNA vaccines, which now expands its offering into the AAV market.
Demand for dbDNA has grown rapidly in the last year and the technology promises to revolutionise how genetic medicine is developed and manufactured. As a result of these transactions, both organizations expect continued expansion and significant growth of their provision of dbDNA to the AAV market.
dbDNA is a linear, double stranded, covalently closed DNA molecule which is produced in an enzymatic manufacturing process. It has the potential to enable faster, safer and more scalable DNA production than other traditional methods without contamination of the plasmid DNA backbone.
Financial details of the agreement are not disclosed.
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG acquired in 2020, is a fully integrated gene therapy company dedicated to developing life-saving medicines that have the potential to cure genetic diseases. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes therapeutics for Pompe disease, Parkinson’s disease and congestive heart failure, as well as out-licensed clinical indications for hemophilia and Duchenne muscular dystrophy. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK, the company has generated hundreds of proprietary third-generation AAV capsids and promoters, several of which have entered clinical testing. Founded in 2001 and an early innovator in the gene therapy field, the company holds more than 800 patents in areas such as AAV production and chimeric and self-complementary capsids. Learn more at www.askbio.com or follow us on LinkedIn and Twitter.
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Touchlight is a privately-owned biotechnology company based in London, U.K., focused on the discovery and development of DNA-based genetic medicines, including DNA vaccines and gene therapies. Touchlight has developed a novel, synthetic DNA vector known as “doggybone” or dbDNA™. dbDNA™ is a minimal, linear, covalently closed structure, that eliminates bacterial sequences. Touchlight’s revolutionary enzymatic production platform enables unprecedented speed, scale, and the ability to target genes with a size and complexity that is impossible with current technologies. Touchlight is applying dbDNA across advanced therapeutic modalities, both in-house and with partners. The company also provides contract manufacturing capabilities to produce dbDNA as a critical starting material for advanced therapy production through its manufacturing arm, Touchlight DNA Services. Learn more at https://www.touchlight.com
For more information about Touchlight please contact:
Founded in 2018 as a joint venture between AskBio and Touchlight, TAAV holds rights to manufacture doggybone DNA (dbDNA), as an alternative to plasmid DNA for use in the adeno-associated virus (AAV) market. Touchlight’s proprietary dbDNA technology is a disruptive technology in the DNA market and is deployed within TAAV to create a new industry standard for transfection-based AAV production. Touchlight’s synthetic process enables TAAV to offer high yield at small scales, shortening manufacturing timelines, facilitating quicker production of AAV and increasing safety by eliminating residual bacterial sequences of plasmid DNA in the AAV product. TAAV launched its state-of-the-art facility located in San Sebastian, Spain, comprised of four suites and additional support labs, that are specifically designed for the manufacture of high quality AAV dbDNA.
AskBio Forward-Looking Statements
This press release contains “forward-looking statements.” Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding AskBio’s manufacturing capabilities. These forward-looking statements involve risks and uncertainties, many of which are beyond AskBio’s control. Known risks include, among others: AskBio may not successfully be able to execute on its business plans and goals, including meeting its expected or planned timelines, its reliance on third-parties, clinical development plans, manufacturing processes and plans, and bringing its product candidates to market, due to a variety of reasons, including the ongoing COVID-19 pandemic, possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved in a timely manner, potential disagreements or other issues with our third-party collaborators and partners, and regulatory, court or agency feedback or decisions, such as feedback and decisions from the United States Food and Drug Administration or the United States Patent and Trademark Office. Any of the foregoing risks could materially and adversely affect AskBio’s business and results of operations. You should not place undue reliance on the forward-looking statements contained in this press release. AskBio does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses, before special items, amounted to 4.9 billion euros. For more information, go to www.bayer.com.
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