Rich Hey­man's Metacrine tacks on an­oth­er $65M to tack­le a su­pe­ri­or NASH drug

Just six months af­ter un­wrap­ping its B round to push a NASH drug through the clin­ic, San Diego’s Metacrine is ramp­ing up ef­forts to­wards that cause with a $65 mil­lion in­fu­sion of cash.

Rich Hey­man

The mon­ey comes from a long list of new in­vestors led by Ven­rock, and it brings the start­up’s to­tal VC haul to $125 mil­lion since its 2015 found­ing. The com­pa­ny was co-found­ed by se­r­i­al en­tre­pre­neur Rich Hey­man — the man be­hind Aragon and Ser­agon, which both sold for over $1 bil­lion in the span of one year — and Ronald Evans, the Salk sci­en­tist be­hind a slew of biotech com­pa­nies, in­clud­ing Lig­and Phar­ma­ceu­ti­cals and the re­cent­ly ac­quired Mi­to­bridge. Both Evans and Hey­man are still in­volved with Metacrine: Hey­man is chair­man, while Evans sits on the board.

Metacrine is tack­ling ther­a­pies in liv­er, gas­troin­testi­nal and meta­bol­ic dis­eases, with a lead NASH pro­gram called MET409.

Ken Song

The com­pa­ny’s CEO, Ken Song, who’s led Metacrine for just un­der two years now, told me late last year he’s acute­ly aware of the need to dif­fer­en­ti­ate from oth­er play­ers pur­su­ing NASH.

“This is prob­a­bly one of the most com­pet­i­tive ar­eas in biotech right now,” Song said. “It’s an enor­mous dis­ease in­di­ca­tion, and there’s no ap­proved ther­a­pies in the space. Those two fac­tors are dri­ving a lot of in­ter­est. Every week there’s an­oth­er new an­gle or new tar­get.”

The start­up’s shtick is not to find a brand new tar­get to take down NASH. In­stead, Song said the com­pa­ny is fo­cus­ing on the on­ly clin­i­cal­ly-val­i­dat­ed tar­get in the space: the Far­ne­soid X Re­cep­tor. FXR is a nu­clear hor­mone re­cep­tor, which is a class of pro­teins Evans hap­pens to be an ex­pert in.

The tar­get has been val­i­dat­ed by In­ter­cept, a com­pa­ny that’s in its own Phase III tri­al in­volv­ing a bile acid FXR ag­o­nist in NASH. But Song said this ap­proach ap­pears to come with some un­want­ed side ef­fects for pa­tients: itch­i­ness and a boost to their LDL cho­les­terol.

Metacrine has ideas on what’s caus­ing both side ef­fects: the bile acid. So the com­pa­ny plans to try out a non-bile acid FXR ag­o­nist in hopes to re­solve the is­sues.

The com­pa­ny plans to use cash from this re­cent round to fi­nance MET409’s progress in the clin­ic, with a Phase I study set for ear­ly 2019. Metacrine al­so has plans for ap­pli­ca­tions in IBS-D, and in­flam­ma­to­ry bow­el dis­ease, and to ex­pand its pipeline through some in­ter­nal dis­cov­ery work.

“The strong in­ter­est from high-qual­i­ty in­vestors fur­ther val­i­dates the po­ten­tial of MET409 for treat­ing liv­er and gas­troin­testi­nal dis­eases,” Song said in a state­ment. “We have pur­pose­ful­ly de­signed an in­dus­try lead­ing FXR ag­o­nist port­fo­lio with the po­ten­tial for best-in-class ther­a­py in NASH and first-in-class ther­a­pies for IBS-D and IBD.”

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.

RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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