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.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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