Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Gink­go inks $144M deal with Mer­ck to en­gi­neer en­zymes to im­prove in­gre­di­ent man­u­fac­tur­ing

While Mer­ck has not been averse to part­ner­ing with small­er com­pa­nies and the odd start­up, its lat­est part­ner­ship sees it link­ing arms with Gink­go Bioworks to help boost ac­tive phar­ma­ceu­ti­cal in­gre­di­ent pro­duc­tion through the use of en­zymes.

The part­ner­ship will have Gink­go de­vel­op a strain of bio­cat­a­lysts that can be used in chem­i­cal syn­the­sis for the pro­duc­tion of APIs. Gink­go can earn up­front R&D fees and mile­stone pay­ments, as well as com­mer­cial pay­ments which have the po­ten­tial to rake in up to $144 mil­lion for the com­pa­ny.

Gink­go’s CEO Ja­son Kel­ly told End­points News that this is not new ter­ri­to­ry for Gink­go, and it has worked on projects with phar­ma com­pa­nies such as No­vo Nordisk and Bio­gen in the past. The com­pa­ny is al­so suit­ed to dis­cov­er­ies in the field of en­zymes. Kel­ly said that the process took around three months to put to­geth­er and will be look­ing to make four to five cat­a­lysts for Mer­ck.

One of the things they were ex­cit­ed about is we can do this in dif­fer­ent host strains, that is the tra­di­tion­al E. coli, which is what most folks that have worked in bio­cat­a­lysts pre­vi­ous­ly have ex­pressed these het­erol­o­gous en­zymes in E. coli and there are cer­tain types of en­zymes that don’t ex­press well in E. coli. So, we can ex­plore a big­ger en­zyme space be­cause we work in sev­er­al fun­gal hosts, in ad­di­tion to E. coli, and so that’s what they were ex­cit­ed about. They want­ed us to try to go af­ter some of these hard chem­i­cal steps.

For now, the re­search end of the deal has al­ready start­ed, ac­cord­ing to Kel­ly, and is ex­pect­ed to be com­plet­ed in around 12 to 18 months. Af­ter that, the re­searched strain will be pro­duced at a small­er lev­el be­fore Mer­ck, or an­oth­er man­u­fac­tur­er, will even­tu­al­ly make the en­zyme for com­mer­cial use.

For Kel­ly, this deal is a ma­jor step:

The re­al­i­ty is what we have on the plat­form to­day, par­tic­u­lar­ly with hav­ing more op­tions than E. coli, plus all our metage­nom­ic hunt­ing, be­ing able to go look in these gi­ant pro­pri­etary genome data­bas­es to find bet­ter en­zymes, and we have huge data­bas­es of mi­cro­bial col­lec­tions that we’ve se­quenced of our own. That is a unique as­set in the in­dus­try, and so we’re hope­ful that we get to go around and talk to every­body that’s do­ing that kind of man­u­fac­tur­ing and sell­ing them a bio­cat­a­lyst deal.

As the US gov­ern­ment is now pump­ing mil­lions of dol­lars in­to bio­man­u­fac­tur­ing for APIs, Kel­ly al­so said that com­pa­nies will be look­ing to­ward more do­mes­tic ef­forts in syn­thet­ic bio­chem­istry to help in steps that may be too ex­pen­sive. And if the deal is ul­ti­mate­ly suc­cess­ful for Gink­go, there are oth­er syn­thet­ic steps in API man­u­fac­tur­ing that the com­pa­ny can step in and try to ac­com­mo­date in the fu­ture.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Geoff McDonough, Generation Bio president and CEO

Mod­er­na part­ners on non-vi­ral gene ther­a­py with Gen­er­a­tion Bio af­ter swing­ing gene edit­ing deals

Moderna has inked a five-year partnership with gene therapy biotech Generation Bio, it announced Thursday morning, wading deeper into the genetic medicines space as it navigates beyond its vaccine work.

Moderna will pay Generation Bio $40 million upfront and invest another $36 million into the gene therapy biotech. In exchange, Moderna can license Generation Bio’s non-viral gene therapy platforms for two immune cell programs and two liver programs, with an option for a fifth program. Moderna will fund all the research work under the partnership, and could be on the hook for milestone, fee and royalty payments totaling up to $1.8 billion, a company spokesperson tells Endpoints News.

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Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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Genen­tech to halt com­mer­cial man­u­fac­tur­ing in Cal­i­for­nia HQ, with lay­offs at­tached

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate its commercial manufacturing operations from its South San Francisco headquarters said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech will produce medicines at its new clinical supply center, which opened in South San Francisco last year while many of its commercial products will be made at other production sites or by contract manufacturers.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.