Carolyn Loew, Glympse Bio CEO

Gilead-part­nered Glympse snares $46.7M for their NASH-snoop­ing biosen­sors

Since its emer­gence at JP Mor­gan six years ago, the NASH field has been held back not on­ly by the ques­tion of how to treat the dis­ease, but al­so by the ques­tion of how you di­ag­nose it. It’s sim­ply not that dif­fi­cult to tell if a liv­er is fat­ty or scarred or in full-on cir­rho­sis.

The method used in most tri­als is nee­dle biop­sy, where you take a hol­low nee­dle, stick it through some­one’s skin and in­to their liv­er and suck out some cells. You stain those cells and ex­am­ine them un­der the mi­cro­scope. It’s safe but very painful, and that pain lim­its how of­ten you can test a pa­tient in a tri­al, and, down the line, how many of the mil­lions of Amer­i­cans sus­pect­ed to have NASH would ac­tu­al­ly be test­ed for the dis­ease and po­ten­tial­ly pre­scribed an ap­proved drug.

Which is why Glympse Bio was able to raise a $22 mil­lion Se­ries A two years ago off their NASH di­ag­no­sis plat­form and land a col­lab­o­ra­tion with Gilead, ar­guably the largest com­pa­ny mak­ing a ma­jor push in­to the field. And why to­day, they were able to land an­oth­er $46.7 mil­lion in a Se­ries B from Sec­tion 32 and more than 10 oth­er in­vestors to bring that plat­form clos­er to use in tri­als and doc­tors’ of­fices.

“In NASH specif­i­cal­ly there’s a re­al need for a tech­nol­o­gy that can both di­ag­nose dis­ease and pre­dict treat­ment re­sponse,” Glympse CEO Car­olyn Loew told End­points News. “What we have the abil­i­ty to do is de­tect re­al-time bi­o­log­i­cal changes at the site of dis­ease.”

Glympse is one of sev­er­al dif­fer­ent com­pa­nies try­ing to de­vel­op bet­ter di­ag­nos­tic tools for NASH. Gen­fit is de­vel­op­ing a blood-based test, one that ap­pears like­ly to be­come an in­creased fo­cus for the com­pa­ny af­ter the NASH drug went bust in Phase III ear­li­er this year. In­ter­cept has used a range of ex­per­i­men­tal met­rics along­side tra­di­tion­al ones in their most re­cent tri­als.

Glympse’s plat­form in­volves in­ject­ing in­to pa­tients tiny biosen­sors that are meant to “query” the body for dis­ease. Ba­si­cal­ly, they mea­sure the pro­teas­es, pow­er­ful cut­ting en­zymes that are dis­reg­u­lat­ed in in­flam­ma­to­ry con­di­tions and can­cers. In­ves­ti­ga­tors col­lect those sen­sors from urine to get a mea­sure­ment. “It’s safe, re­peat­able, non-in­va­sive,” Loew said.

The idea is that these sen­sors can de­tect pa­tients who have NASH or are at risk of de­vel­op­ing NASH bet­ter than nee­dle biop­sies that are used to de­tect liv­er scar­ring or the scans that are used to de­tect fat­ty buildup, both of which can be in­ac­cu­rate. The ac­cu­ra­cy of the nee­dle biop­sy, in par­tic­u­lar, can de­pend on where in the liv­er you prick.

“The sam­ple you take is very vari­able and how pathol­o­gists read the slides is al­so very vari­able,” Loew said.  “So you’ve got this in­her­ent vari­abil­i­ty.”

The sen­sors are al­so sup­posed to be able to pre­dict and de­tect re­sponse to treat­ment. In the long term, Loew said, they could be used to test pa­tients for NASH or NASH risk ear­li­er than cur­rent­ly pos­si­ble and fig­ure out quick­ly whether or not a ther­a­py works. In the short­er term, Glympse is work­ing with Gilead to se­lect pa­tients for their clin­i­cal tri­als and quick­ly mea­sure if the drug is work­ing, al­low­ing the Cal­i­for­nia drug­mak­er to de­cide faster if fur­ther in­vest­ment is worth­while.

Mean­while, Glympse is al­so de­vel­op­ing biosen­sors for can­cer and in­fec­tious dis­ease. The in­fec­tious dis­ease pro­gram re­mains un­der wraps — a Covid-19 test, maybe? — but the idea be­hind the can­cer pro­gram is that it will al­low clin­i­cians and drug de­vel­op­ers to know much quick­er than cur­rent­ly pos­si­ble whether a drug is hav­ing a bi­o­log­i­cal ef­fect, al­low­ing a doc­tor to switch ther­a­pies or a com­pa­ny to fo­cus re­sources else­where. Loew said it will be par­tic­u­lar­ly im­por­tant for im­munother­a­pies, which of­ten take longer to show their ef­fects.

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Andrea Pfeifer, AC Immune CEO (AC Immune)

Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

The German billionaires behind BioNTech have found a new vaccine project to back.

Through their family office Athos Service, twin brothers Thomas and Andreas Strüngmann are leading a $25 million private placement into Switzerland’s AC Immune — which concurrently announced that it’s shelling out $58.7 million worth of stock to acquire Affiris’ portfolio of therapies targeting alpha-synuclein, including a vaccine candidate, for Parkinson’s disease.

Rajiv Shukla, Constellation Alpha Holdings

Can­del gets busy IPO week mov­ing with down­sized raise as Ra­jiv Shuk­la's third SPAC goes pub­lic

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

In a week that’s expected to see several biotechs price their IPOs, Candel Therapeutics got things kicked off Tuesday with a muted opener.

The company helmed by former GlaxoSmithKline vet Paul Peter Tak made its way to Nasdaq thanks to a $72 million raise, which was downsized by about 15% than originally anticipated, according to Renaissance Capital. Candel priced at $8 per share after initially seeking to launch in the $13 to $15 range.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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