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.

Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha raise $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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My­ovant lands a fresh $200M loan as FDA mar­ket­ing de­ci­sion looms; Amarin goes it alone in Eu­rope

Myovant is getting ready to roll out its commercial operations to back relugolix, now under FDA review for prostate cancer.

The startup has added a fresh $200 million in support from Sumitomo Dainippon Pharma, which controls a majority of the stock $MYOV. Sumitomo is handing the cash over as a loan, bringing its total to $600 million. Myovant — which is gearing up for a showdown with AbbVie — has also filed an NDA to sell relugolix for uterine fibroids and recently posted positive late-stage data for endometriosis.

Ver­sant de­buts Ridge­line's start­up #4, armed with $30M and al­ter­na­tive TCR cell ther­a­pies for sol­id tu­mors

For all the iterations and advances in TCR therapies for cancer, any experimental treatments involving T cell receptors share one trait: By definition, they only recognize antigens presented as peptides on the major histocompatibility complex (MHC) on cells.

Versant reckons it’s time to expand the arsenal. With $30 million in initial funding, its Ridgeline Discovery Engine in Switzerland has been working on a non-peptidic approach that it says has tumor-agnostic potential, especially in solid tumors. They’ve named it Matterhorn, after a Swiss mountain as they did with the three other companies that have emerged from the Basel-based incubator.

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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CF Foun­da­tion, Long­wood team on new in­cu­ba­tor for com­pa­nies with cut­ting-edge CF treat­ments

Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

The CF Foundation, whose venture philanthropy efforts helped fund Vertex’s line of powerful CF drugs, is teaming with Longwood Fund to create a CF incubator. The incubator will identify new companies with platforms or technologies that can be applied in the rare genetic condition. The partners can then finance early development in exchange for a commitment from the companies to focus on applications in cystic fibrosis.