Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Near­ly a year ago, as the pan­dem­ic en­croached and the stock mar­ket cratered, Flag­ship and ARCH Ven­ture an­nounced three mega-funds worth a com­bined $2.6 bil­lion. They want­ed, ARCH’s Bob Nelsen said, to re­store con­fi­dence “that there was mon­ey out there and a lot of it” to in­vest in biotech.

Since then, the stock mar­ket has re­turned — al­most fright­en­ing­ly so — and Nelsen has kept rais­ing and spend­ing cash. On Thurs­day, he an­nounced a new fund, worth $1.85 bil­lion. It’s the largest pot yet for a VC fa­mous for its deep pock­ets.

This time, he said, there’s no mes­sage oth­er than what they’ve been say­ing for years.

“It’s just a con­tin­ued con­fi­dence in ba­sic sci­ence, and in­no­va­tion that’s hap­pen­ing in health­care; it’s re­al­ly a rev­o­lu­tion­ary time,” he told End­points News. It’s “keep­ing your head down and con­tin­u­ing to do what you do.”

His­tor­i­cal­ly, ARCH has been known for back­ing huge plays with record in­vest­ments, most re­cent­ly launch­ing Re­silience with $800 mil­lion and a plan to re­think how all bi­o­log­ic drugs are made. An­oth­er ma­jor bet, the in­fec­tious dis­ease start­up Vir, may yet play a ma­jor role in the pan­dem­ic, lead­ing one of the ma­jor ef­forts to de­vel­op a neu­tral­iz­ing an­ti­body for Covid-19.

In an­nounc­ing the new fund, Nelsen ticked off a range of ar­eas the firm will look to pur­sue, most of which ARCH has pre­vi­ous­ly pushed for­ward, in­clud­ing gene edit­ing and cell ther­a­py.

“Men­tal health is at the top of my mind,” he said.

ARCH has played a key role in pre­vi­ous men­tal health biotechs, most no­tably back­ing Sage Ther­a­peu­tics and Karuna. Nelsen said they may al­so in­vest in ap­proach­es to the is­sue out­side drug de­vel­op­ment, back­ing ef­forts in con­sumer health and health tech.

Al­though known for its huge plays, ARCH al­so hands out about 20 so-called “poor” deals that can range as low as $50,000 and ei­ther pro­vide seed cash for a par­tic­u­lar idea or help feed in­to a larg­er com­pa­ny. Both Vir and Re­silience, for ex­am­ple, com­bined mul­ti­ple small­er com­pa­nies in­to a large one, which then gar­nered sig­nif­i­cant in­vest­ment.

Not all those in­vest­ments, though, have worked out. Last year, Nelsen stepped away from the board of Uni­ty Biotech­nol­o­gy, an an­ti-ag­ing start­up that at­tract­ed sig­nif­i­cant in­vest­ment but failed a ma­jor tri­al last year. It’s at least the sec­ond ma­jor set­back he’s seen in an an­ti-ag­ing play, af­ter a late 90s, ear­ly 2000s bet on Cyn­thia Keny­on’s Elixir Phar­ma­ceu­ti­cals went un­der.

Still, ARCH in­clud­ed it on a list of po­ten­tial ar­eas for the new fund, and Nelsen said he hasn’t lost faith. They’re con­tin­u­ing to mon­i­tor the field, he said.

Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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CEO Marco Taglietti (Scynexis)

'N­ev­er been more ur­gent:' Scynex­is looks to tack­le su­per­bug cri­sis with late-stage read­out for an­ti­fun­gal hope­ful

As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.

“The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic,” CEO Marco Taglietti said in a statement.

A spot­light schiz­o­phre­nia drug in Neu­ro­crine's $2B Take­da deal flunks its first ma­jor test. But it's not giv­ing up yet

When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”

On Tuesday, we got some idea of how difficult.

San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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