Rob Brainin (Genuity)

Meet the lat­est ge­nom­ic da­ta com­pa­ny — aka WuXi NextCODE with­out the Chi­na op­er­a­tions

Just five years af­ter WuXi en­gi­neered a deal to merge its genome cen­ter with NextCODE Health, the WuXi NextCODE brand is be­com­ing his­to­ry as the com­pa­ny cuts off the Chi­nese op­er­a­tions and fo­cus­es on the US, Ice­land and Ire­land.

The new name, Ge­nu­ity Sci­ence, eras­es all ref­er­ences to WuXi NextCODE’s sto­ried his­to­ry. The US and Ice­land of­fices of the ge­nomics com­pa­ny were spun out of de­CODE Ge­net­ics af­ter it got ac­quired by Am­gen — with its own twists and turns. Its $400 mil­lion ex­pan­sion in­to Ire­land took place in late 2018, com­plete with the ac­qui­si­tion of Ge­nomics Med­i­cine Ire­land.

Where­as WuXi NextCODE had moved its head­quar­ters from Shang­hai to Cam­bridge over two years, Ge­nu­ity will shift its com­mand cen­ter to Boston.

Ac­cord­ing to the com­pa­ny, the rea­son for cut­ting off its Chi­na ties is pure­ly le­gal. Chi­na tight­ened its Hu­man Ge­net­ics Re­source Reg­u­la­tion and oth­er rules in mid-2019, and NextCODE was among many com­pa­nies that were des­ig­nat­ed as for­eign en­ti­ties — erect­ing se­ri­ous con­straints to their work and pos­si­bil­i­ty for growth overnight.

The ca­pa­bil­i­ties they had in Shang­hai were “val­ued by a num­ber of our in­ter­na­tion­al cus­tomers,” said Rob Brain­in, whose cards now say CEO of Ge­nu­ity.

Now that it’s gone, they have poured more re­sources in both Dublin and Woburn, MA, to do some of the things their Chi­nese col­leagues used to han­dle.

Be­tween the three re­main­ing sites, Ge­nu­ity has more than 200 em­ploy­ees sourc­ing, con­sol­i­dat­ing and an­a­lyz­ing ge­nom­ic da­ta for part­ners. Re­cent­ly, they’ve be­gun sup­port­ing Irish re­search in­sti­tu­tions in se­quenc­ing the genomes of Covid-19 pa­tients.

Of­fi­cial sep­a­ra­tion from the Shang­hai of­fice is slat­ed for lat­er this year, al­though Ge­nu­ity is al­ready con­sid­er­ing what to do with it.

De­spite the shake­up, its in­vestor base ac­tu­al­ly re­mains the same, fea­tur­ing some mar­quee names such as Temasek, ARCH and Se­quoia Cap­i­tal. None of them, Brain­in felt com­pelled to add, will have ac­cess to sen­si­tive in­for­ma­tion or in­ter­nal da­ta.

As he clar­i­fied in an email:

WuXi NextCODE is not owned by WuXi AppTec or oth­er WuXi com­pa­nies. Since 2017, WuXi NextCODE has been op­er­at­ing as an in­de­pen­dent pri­vate com­pa­ny with for­mer WuXi Phar­maT­e­ch share­hold­ers serv­ing among the com­pa­ny’s many in­vestors.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

Stephen Hahn, AP

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

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Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is paying out a $25 million upfront for the rights to sell Turning Point Therapeutics’ lead drug repotrectinib in Greater China. The San Diego-based biotech is also in line for up to $151 million in milestones, along with mid-to-high teen royalties. Zai plans to add sites to the Phase II trial of the drug, which is designed to treat ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI.

Sin­gu­lar fo­cus on ROR1 earns Velos­Bio $137M to fund PhI ADC and oth­er pro­grams

Years after selling Acerta to AstraZeneca for $7 billion, largely on the promise of its BTK inhibitor, Dave Johnson has once again gathered hefty financial support behind a new cancer target.

Matrix Capital Management and Surveyor Capital are leading a $137 million round for VelosBio, which has recently begun a Phase I study for its lead antibody-drug conjugate targeted against ROR1. Johnson took up the CEO post in October 2018.

Roger Tung, Concert Pharmaceuticals CEO (Concert)

Con­cert gets BTD for alope­cia drug, set­ting up a late-stage show­down with gi­ant ri­val Pfiz­er

Concert Pharmaceuticals’ path to developing a drug that treats alopecia areata has been bumpy, but the pharma company scored a win Wednesday.

The FDA granted Concert a Breakthrough Therapy Designation (BTD) for its oral Janus kinase inhibitor, named CTP-543, paving the way for a Phase III study of the drug to begin in the fourth quarter of 2020. The news follows positive Phase II results from last September, which saw the drug meet its primary endpoint in both 8 mg and 12 mg twice-daily doses.