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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

CEO Stephen Yoder (Pieris)

Pieris fi­nal­ly vaults FDA hold on next-gen sol­id tu­mor hunter, clear­ing the path for mid-stage tri­al

Finally freed from the restraints of a partial FDA clinical hold on its lead HER2-positive solid tumor candidate, Pieris Pharmaceuticals is now racing toward Phase II.

The FDA slapped a partial hold on Pieris’ PRS-343 back in July, restricting the biotech from enrolling new patients in a Phase I trial. While Pieris was allowed to continue dosing patients who were already enrolled, the agency requested they conduct an additional “in-use and compatibility study” before recruiting any more.

News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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The IPO flood keeps ris­ing with 4 more biotechs and a SPAC on their way to Nas­daq

After a record year for biotech IPOs in 2020, forecasts were bullish on another strong year showing for public offerings — and 2021 hasn’t disappointed so far. Now, a clutch of four biotechs chasing rare disease and cancer and a New York SPAC are ready to join the party.

Three more companies filed to head to Nasdaq on Tuesday, as well as a SPAC, with an additional Dutch biotech filing Friday. All in all, early days indicate another big year, at least to start, with 12 companies either pricing or filing their IPOs in the first 20 days of January.