Striv­ing for high­er res imag­ing of cells, Har­vard team de­buts start­up with back­ing from ARCH, North­pond

As sci­en­tists race to find new ways to look in­to what’s go­ing on in­side cells, ARCH Ven­ture Part­ners and North­pond Ven­tures are in­ject­ing $14 mil­lion in­to a Har­vard team promis­ing to vi­su­al­ize ac­tiv­i­ty on a “sub­cel­lu­lar lev­el” — down to every RNA.

Xi­aowei Zhuang

Xi­aowei Zhuang and David Walt are two of the promi­nent sci­en­tists be­hind Viz­gen. Zhuang, a Howard Hugh­es Med­ical In­sti­tute In­ves­ti­ga­tor and Har­vard pro­fes­sor, was the in­ven­tor of an­oth­er pop­u­lar su­per-res­o­lu­tion mi­croscopy method while David Walt was a sci­en­tif­ic founder of the se­quenc­ing gi­ant Il­lu­mi­na.

Viz­gen was found­ed on MER­FISH, or mul­ti­plexed er­ror-ro­bust flu­o­res­cence in situ hy­bridiza­tion, which was in­vent­ed by Jef­frey Mof­fitt while he was a post­doc at Zhuang’s lab. MER­FISH is, in turn, built on FISH — a tech­nol­o­gy that’s been used for decades to de­tect DNA or RNA tar­gets by send­ing flu­o­res­cent probes to bind to them.

David Walt

The new imag­ing tech­nol­o­gy lever­ages new er­ror de­tec­tion and cor­rec­tion tech­niques, in­clud­ing bar­cod­ing schemes and com­bi­na­to­r­i­al la­bel­ing and imag­ing, to achieve high­er ac­cu­ra­cy and save time.

As a re­sult, it al­lows sci­en­tists to in­ves­ti­gate many more RNA species, ac­cord­ing to the com­pa­ny.

“Giv­en its abil­i­ty to quan­ti­fy RNAs across a wide range of abun­dances with­out am­pli­fi­ca­tion bias while pre­serv­ing na­tive con­text, we en­vi­sion that MER­FISH will en­able many ap­pli­ca­tions of in situ tran­scrip­tom­ic analy­ses of in­di­vid­ual cells in cul­ture or com­plex tis­sues,” Zhuang and Mof­fitt wrote with col­lab­o­ra­tors in a pa­per in­tro­duc­ing the tech in 2015.

Walt fur­ther ex­plained why that’s use­ful in an in­ter­view with Xcon­o­my:

Every im­age that’s tak­en as a con­se­quence of the way that this process is done is done with ap­prox­i­mate­ly 100 nanome­ters of res­o­lu­tion, so you can zoom out all the way to the whole tis­sue and see where the gene ex­pres­sion is oc­cur­ring, then you can zoom in to a sin­gle cell and look at the sub­cel­lu­lar ex­pres­sion of every one of those RNAs that are present in the sam­ple.

Jef­frey Mof­fitt

That can tell re­searchers a lot about cell type, state, or­ga­ni­za­tion, in­ter­ac­tions as well as func­tion with­in the tis­sue.

“The deep in­for­ma­tion un­locked by MER­FISH ex­pos­es bi­ol­o­gy at the net­work lev­el, dri­ving in­sights that will help us build the fu­ture of hu­man health,” Kei­th Cran­dell, man­ag­ing di­rec­tor at ARCH, said in a state­ment.

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

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

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

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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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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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

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 in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.