Akero el­bows its way in­to a crowd­ed NASH field, with $65M and a strat­e­gy for tack­ling a block­buster mar­ket

Over the last few weeks we’ve been treat­ed to a cou­ple of sto­ries about small biotechs which en­joyed a swift run-up in stock val­ues af­ter post­ing their beau­ty shots of clin­i­cal da­ta for NASH drugs. NASH re­mains the big new dis­ease tar­get that is suck­ing up a lot of R&D at­ten­tion at large and small bio­phar­mas around the world, and in­vestors are look­ing to ride one of the win­ning play­ers to the promised land.

You can now add a new com­pa­ny to watch in this sul­try re­search zone. And it’s a brand new ba­by that’s been gift­ed with $65 mil­lion in op­er­at­ing cap­i­tal and a deeply ex­pe­ri­enced Pfiz­er vet to head up the re­search work.

The com­pa­ny has been dubbed Akero, which is de­but­ing to­day with a Cam­bridge base and $65 mil­lion in Se­ries A cash, with Ap­ple Tree Part­ners lead­ing the way. 

Now, with all the clin­i­cal work that’s been go­ing on for the last few years in NASH, you might think that we’ve al­ready seen the even­tu­al win­ners jump for­ward. But then, you haven’t met the peo­ple at Akero.

The start­up has in-li­censed an FGF21 drug that’s al­ready been through ear­ly-stage work at Am­gen, which let it go be­cause of their move away from meta­bol­ics.

This isn’t the first FGF21 in the clin­i­cal. Bris­tol-My­ers has one that has been through Phase II. 

Tim Rolph

“My ex­pe­ri­ence with FGF21 goes back 8 years,” says Akero CSO Tim Rolph. It start­ed at Pfiz­er and con­tin­ued af­ter he left the phar­ma gi­ant. The sci­ence around FGF21, he adds, has grown ex­po­nen­tial­ly in the last 3 to 4 years. 

“It’s a mech­a­nism that us­es the whole body to get to a bet­ter place,” says Rolph. “It plays an es­sen­tial role restor­ing cells un­der stress — that’s what drove my in­ter­est.”

Jonathon Young, the CEO, and Rolph went to go out in search of drug, and found this pro­gram at Am­gen, which li­censed it out. And the two are pumped about the en­gi­neer­ing work that has gone in­to it to give the drug longer dura­bil­i­ty.

Ap­ple Tree Part­ners, where Young has been a part­ner, seed­ed the project. At­las Ven­ture, ven­Bio Part­ners and Ver­sant Ven­tures all joined as co-leads, mak­ing an im­pres­sive group of deep-pock­et in­vestors. They’ll be rep­re­sent­ed on the board by Aaron Kantoff, Kevin Bit­ter­man, Aaron Roys­ton and Gra­ham Walm­s­ley.

Young — like a lot of start­up biotech CEOs — gets a lit­tle skit­tish when you try to nail down the staff plans right now. There are the two founders, he says, with plans to add more em­ploy­ees. We’ll see how that goes. 

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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A T-cell play­er with back­ing from Roche takes next big step for BiTE drugs with 'on-of­f' switch to avoid tox­i­c­i­ty

The bispecific T cell engager field is absolutely packed with big-name players who have crowded in despite some high-profile failures in the class. Now, a Bay Area biotech thinks it may have the key to tackling BiTE toxicity, using an old “on-off switch” idea to give doctors more control of the drugs’ effect on patients.

San Francisco-based Soteria Biotherapeutics uncloaked Monday with a $42 million Series A co-led by Roche Venture Fund and 5AM Ventures with participation from the Novartis Venture Fund to advance its bispecific T cell engagers with an “on-off” switch the founders think can avoid some of the dire safety flags endemic to the class.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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