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. 

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Francesco De Rubertis

Medicx­i's David Grainger and Francesco De Ru­ber­tis pump €200M in­to six com­pa­nies and what they say is a first-of-its kind fund

In what they’re billing as a first for biotech, David Grainger, Francesco De Rubertis and their team at Medicxi have put down €200 million to sweep up stakes in six companies from their predecessor VC and pump new money into them.

Medicxi didn’t disclose which companies it was investing in but the portfolio draws from Index Ventures Life VI, one of the last funds the Medicxi team launched while they were still part of the multinational, tech-focused VC firm Index Ventures. That team kept advising Index on their life sciences portfolio even after they spun out to form their own firm in the middle of 2016.

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News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.