News brief­ing: Beam bags a $260M pri­vate place­ment; mi­Ra­gen re­brands to Virid­i­an Ther­a­peu­tics

Agios vet John Evans has demon­strat­ed how to raise big mon­ey for a lit­tle biotech.

The Beam Ther­a­peu­tics CEO — and ARCH part­ner — has pieced to­geth­er a $260 mil­lion pri­vate place­ment from a group of back­ers that in­cludes Per­cep­tive Ad­vi­sors, Far­al­lon Cap­i­tal, Cas­din Cap­i­tal, Red­mile Group and Cor­morant As­set Man­age­ment. And there are 3 main goals they’ll pur­sue with it: clin­i­cal de­vel­op­ment, strate­gic part­ner­ships and gen­er­al cor­po­rate pur­pos­es.

Beam us­es a CRISPR plat­form built on the ideas of gene-edit­ing pi­o­neers David Liu, Feng Zhang, and J Kei­th Joung. And the biotech raised $180 mil­lion when it went pub­lic {BEAM} about a year ago. — John Car­roll

Fol­low­ing re­struc­tur­ing, mi­Ra­gen changes name to Virid­i­an Ther­a­peu­tics

mi­Ra­gen Ther­a­peu­tics is get­ting a new name for the new year, tak­ing on the moniker of a com­pa­ny it ac­quired back in Oc­to­ber.

The com­pa­ny an­nounced Tues­day it is re­brand­ing as Virid­i­an Ther­a­peu­tics and, with the move, is get­ting a new stock tick­er. Be­gin­ning Wednes­day, all shares pre­vi­ous­ly trad­ed un­der $MGEN will con­vert to $VRDN to co­in­cide with the name change.

Virid­i­an al­so an­nounced the ap­point­ment of Jonathan Vi­o­lin pres­i­dent, CEO and mem­ber of the board of di­rec­tors. The com­pa­ny al­so hired Bridge­Bio vet­er­an Bar­rett Katz to be CMO.

The ex-mi­Ra­gen out­fit slashed its work­force in half start­ing last Au­gust, part of a re­struc­tur­ing ef­fort that side­lined new dis­cov­ery ef­forts. For­mer CEO Lee Rauch, for whom Vi­o­lin is tak­ing over, had on­ly served in the po­si­tion since Sep­tem­ber af­ter William Mar­shall re­signed from the po­si­tion. Vi­o­lin pre­vi­ous­ly served as COO.

Virid­i­an is now bet­ting its fu­ture on VRDN-001, the thy­roid eye dis­ease (TED) can­di­date it picked up from the Oc­to­ber ac­qui­si­tion. The IGF-1R mon­o­clon­al an­ti­body was orig­i­nal­ly li­censed from Im­muno­Gen. — Max Gel­man

Inn­o­dem nets $6M Se­ries A to de­vel­op tri­al man­age­ment app for neu­ro­log­i­cal dis­eases

A new com­pa­ny out of Mon­tre­al will have an eas­i­er time look­ing in­to neu­rode­gen­er­a­tive dis­eases, thanks to a $6 mil­lion Se­ries A round.

Inn­o­dem Neu­ro­sciences an­nounced the fundraise Tues­day morn­ing, not­ing the fi­nanc­ing was led by Morn­ing­side Ven­tures. The biotech plans to re­search sev­er­al dis­eases in­clud­ing mul­ti­ple scle­ro­sis, Alzheimer’s dis­ease, Parkin­son’s dis­ease, fron­totem­po­ral de­men­tia and can­cer-re­lat­ed cog­ni­tive im­pair­ment, some­times re­ferred to as “chemo brain.”

The com­pa­ny’s pri­ma­ry tech­nol­o­gy in­volves an app for smart­phones and tablets that help re­searchers di­ag­nose pa­tients by cap­tur­ing eye move­ment bio­mark­ers and gaze map­ping bio­mark­ers. Inn­o­dem then us­es deep learn­ing to re­fine its orig­i­nal al­go­rithm and de­vel­op tech­nol­o­gy to help phar­ma­ceu­ti­cal com­pa­nies man­age clin­i­cal tri­als. — Max Gel­man

On­co­Host bags $8M Se­ries B to fund tri­als in melanoma and NSCLC

Per­son­al­ized can­cer ther­a­py play­er On­co­Host has some new cash to play with.

The com­pa­ny has pulled in $8 mil­lion in a Se­ries B to help fi­nance on­go­ing clin­i­cal tri­als, open a US-based af­fil­i­ate and pre­pare for the up­com­ing launch of a pro­pri­etary ma­chine learn­ing-based plat­form. On­co­Host says the plat­form can com­bine pro­teom­ic analy­sis with AI to pre­dict pa­tient re­sponse to im­munother­a­py, al­low­ing for more op­ti­mal treat­ment strate­gies.

Tues­day’s round was led by Our­Crowd, an in­vest­ment plat­form built specif­i­cal­ly for star­tups. On­co­Host’s tri­als are cur­rent­ly fo­cused on melanoma and non-small cell lung can­cer pa­tients and will soon ex­pand to oth­er in­di­ca­tions. — Max Gel­man

Ep­i­darex Cap­i­tal backs a new twist to IL-2 out of UVA

You can count one more play­er in the hunt for next-gen IL-2 ther­a­pies.

Slate Bio is launch­ing with $1.75 mil­lion seed fi­nanc­ing from Ep­i­darex Cap­i­tal, UVA Li­cens­ing & Ven­tures Group Seed Fund, Cen­ter for In­no­v­a­tive Tech­nol­o­gy’s GAP Bi­o­Life Fund, VTC Seed Fund, Phar­maDi­rec­tions and oth­ers.

The sci­en­tif­ic foun­da­tion comes from the Uni­ver­si­ty of Vir­ginia School of Med­i­cine out of Char­lottesville — one of those “un­der­ven­tured” ar­eas Ep­i­darex likes to look to for fresh ideas.

Walk­ing the fine line be­tween the po­ten­cy and tox­i­c­i­ty of IL-2 has been one of the Holy Grails in R&D, not to men­tion it usu­al­ly has a short half life. Slate’s an­swer is a bi­func­tion­al IL-2/IL-33 fu­sion cy­tokine that aug­ments reg­u­la­to­ry T cells, with a fo­cus on au­toim­mune and in­flam­ma­to­ry dis­eases.

“While Fc-Fu­sions and PE­Gy­lat­ed low-dose IL-2 may im­prove the short half-life of IL-2, these bi­o­log­ics are re­strict­ed to a sin­gle path­way, a nar­row ther­a­peu­tic win­dow and lim­it­ed dura­bil­i­ty,” the com­pa­ny not­ed in a re­lease. — Am­ber Tong

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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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.

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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Mesoblast gets a $110M life­line from Surg­Cen­ter De­vel­op­ment; uniQure still un­sure if gene ther­a­py spurred can­cer event

Mesoblast faced rough waters in 2020, but on Monday were thrown a financial lifeline.

The Australian stem cell therapy player has raised $110 million in a private placement, the company announced, offering 60 million shares to the US investor group SurgCenter Development. SurgCenter received the shares at a 6.5% discount from Mesoblast’s closing price on Feb. 25.

Mesoblast plans to use the funds to boost supply of its lead candidate remestemcel-L ahead of what they hope is a potential approval in pediatric GvHD when they return to the FDA, as well as advancing manufacturing and development of their rexlemestrocel-L platform for chronic heart failure and chronic low back pain.

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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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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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.