Biogen and Ginkgo Bioworks Partner to Redefine AAV-Based Vector Manufacturing

Biogen_John Tlumacki/The Boston Globe via Getty

John Tlumacki/The Boston Globe via Getty Images

Less than two weeks after Ginkgo Bioworks announced a merger with special purpose acquisition company (SPAC) Soaring Eagle Acquisition Corp., it announced a collaboration partnership with Biogen

The two companies, they claim, “aim to redefine the industry standard for manufacturing recombinant adeno-associated virus (AAV)-based vectors.” This is a hot area in gene and cell therapies.

Gingko Bioworks is known as “the organism company.” Its focus is on using microorganisms to engineer various products in a vast swath of markets. This includes fragrances, food and agriculture, antibiotics, vaccines, therapeutics and enzymes. 

In November 2020, Gingko was offered a $1.1 billion loan from the U.S. government for COVID-19 testing and manufacture of raw materials for possible therapies. After its merger with Soaring Eagle and the resultant initial public offering (IPO), it is expected to have a market value of $15 billion.

Under the terms of the deal with Biogen, the company will have access to Ginkgo’s cell programming platform. Gingko will use its technology and resources to improve the AAV production titers of Biogen’s gene therapy manufacturing. 

Biogen is paying Ginkgo $5 million up front, with milestone payments up to another $115 million.

“We believe that Ginkgo’s unique combination of cell programming expertise, proprietary tools and knowledge of biological systems make them an ideal collaboration partner to explore a large number of design ideas with the goal of optimizing constructs,” said Alphonse Galdes, Head of Pharmaceutical Operations and Technology at Biogen. 

“They share our goal of ensuring approved therapies are not delayed by manufacturing constraints and are available to patients worldwide.”

Biogen has a big date just around the corner. The U.S. Food and Drug Administration (FDA) has a target action date of June 7 for Biogen’s aducanumab for Alzheimer’s disease. The drug has had a complex history, with a significant amount of controversy. 

The drug was initially dropped in March 2019 after data suggested it would not meet its primary endpoint. Further data analysis found the drug was promising at the highest dose in a subpopulation. After further investigation, they submitted the application to the agency. 

If approved, analysts have projected annual sales of about $4.8 billion by 2026. However, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted against the drug. The most optimistic analysts have the odds for approval at about 50/50.

And earlier this month, Biogen reported that its gene therapy for X-linked retinitis pigmentosa (XLRP), cotoretigene toliparvovec, missed the primary endpoint of the Phase II/III XIRIUS trial. XLRP is a rare, inherited disease of the retina. 

The company otherwise observed positive trends in some of its secondary endpoints. The therapy is an AAV8 vector-based gene therapy administered by subretinal injection. It allows for delivery of a full-length functioning retinitis pigmentosa GTPase regulator (RPGR) protein in XLRP patients whose disease is the result of RPGR gene mutations.

But the Gingko deal is only the latest in a stream of agreements that show Biogen is working seriously on developing its gene therapy capabilities. Only a week before the trial announcement, Biogen signed a strategic collaboration deal with Capsigen to engineer novel AAV capsids for gene therapy. 

Washington-based Capsigen uses a proprietary TRADE platform and technologies to find and develop novel AAV capsids for disease-specific transduction profiles. 

And in March, Biogen announced plans to build a new gene therapy manufacturing facility in North Carolina to support its manufacturing for itself and its partners. 

Earlier in the year, the company signed a licensing deal with Germany’s CEVEC Pharma for its ELEVECTA Technology to manufacturing AAV vectors for gene therapies. And in January, Biogen and Germany’s ViGeneron GmbH inked a gene therapy collaboration focused on AAV therapies for inherited eye diseases.

Jason Kelly, chief executive officer of Ginkgo Bioworks, said, “We are excited to collaborate with Biogen as they aim to develop treatments that may potentially slow, halt or cure neurological and neurodegenerative diseases and seek to enhance the industry standard for AAV manufacturing. Synthetic biology is leveraging the power of living cells to develop the next generation of therapeutics, everything from CAR-T, to CRISPR and gene therapies, which we believe will have a material impact on the lives of many.”

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