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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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