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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Simba Gill, CEO of Evelo Biosciences

While down 87% YOY, Evelo gets Flag­ship and oth­ers to in­fuse new cap­i­tal for come­back hope

Just four years after Flagship spinout Evelo Biosciences went public in an IPO worth $85 million, the biotech has seen its share price tank from $13 a share this time last year (ultimately reaching a peak of over $17) to now under $1.50. And today, it looks like Flagship still thinks the fledging biotech, in a down market, is still worth something after initial pre-IPO backing from the likes of Google’s GV, Celgene, Mayo Clinic and Alexandria Venture.

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Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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