Hear hear! Ear gene ther­a­py play­er Ak­ou­os draws $105M in fresh cap­i­tal

Come on, come on, lis­ten to the mon­ey talk.

Thriv­ing on the mo­men­tum of biotech­nol­o­gy com­pa­nies work­ing on ther­a­pies to ad­dress hear­ing loss, Boston-based Ak­ou­os has scored $105 mil­lion in an over­sub­scribed Se­ries B fi­nanc­ing, less than two years af­ter an NEA, 5AM Ven­tures-backed $50 mil­lion haul.

Man­ny Si­mons Ak­ou­os

Ak­ou­os — Greek for ‘to hear’ — is de­vel­op­ing gene ther­a­pies en­gi­neered to re­store, im­prove or pre­serve hear­ing. Along with its part­ners — the world’s largest hear­ing re­search cen­ter Mass­a­chu­setts Eye and Ear, as well as Swiss Alps-based vi­ral gene and cell ther­a­py mak­er Lon­za — Ak­ou­os is at the cusp of tak­ing its lead ther­a­py in­to the clin­ic.

The pro­gram, AK-OTOF, is de­signed to help in­di­vid­u­als with sen­sorineur­al hear­ing loss due to mu­ta­tions in the otofer­lin (OTOF) gene.

Led by Man­ny Si­mons, who con­sid­ered be­com­ing a mu­si­cian while at­tend­ing Har­vard, Ak­ou­os has an­oth­er Har­vard man on the ros­ter — co-founder and chief med­ical of­fi­cer Michael McKen­na. On Mon­day, the com­pa­ny added a third Har­vard voice to its board — Vic­ki Sato — who pre­vi­ous­ly served as pres­i­dent of Ver­tex Phar­ma­ceu­ti­cals. Heather Pre­ston of Piv­otal bioVen­ture Part­ners, which led the fresh cap­i­tal in­jec­tion, al­so earned a spot as di­rec­tor.

Oth­er in­vestors in the round in­clud­ed Cor­morant As­set Man­age­ment, Cowen Health­care In­vest­ments, EcoR1 Cap­i­tal, Fi­deli­ty Man­age­ment & Re­search Com­pa­ny, Po­laris Founders Fund, Pags­group, Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), Wu Cap­i­tal, 5AM Ven­tures, New En­ter­prise As­so­ci­ates, No­var­tis Ven­ture Fund, Part­ners In­no­va­tion Fund, RA Cap­i­tal Man­age­ment and Sofinno­va In­vest­ments.

Michael McKen­na Ak­ou­os

Hear­ing aids and cochlear im­plants do ad­dress ear dam­age caused by ge­net­ics, noise, ag­ing, or drugs, but noth­ing quite cures or in­deed tar­gets the bi­o­log­i­cal un­der­pin­nings of hear­ing loss. Vy­ing to fill that gap, a pletho­ra of de­vel­op­ers are work­ing on ther­a­peu­tics in a bur­geon­ing field.

Al­so in Boston, Ak­ou­os’ home, is Deci­bel Ther­a­peu­tics, work­ing on re­gen­er­a­tion by tar­get­ing tiny hairs that grow in the in­ner ear to ad­dress con­gen­i­tal hear­ing loss or age-re­lat­ed bal­ance dis­or­ders. Fre­quen­cy Ther­a­peu­tics has a mid-stage hair cell re­gen­er­a­tion pro­gram us­ing prog­en­i­tor cells.

Across the At­lantic, UK-based Rin­ri Ther­a­peu­tics is work­ing on treat­ing hear­ing loss by trans­plant­i­ng ot­ic neur­al prog­en­i­tor cells in­to the in­ner ear. Am­s­ter­dam-based Au­dion Ther­a­peu­tics has a com­pound in-li­censed from Eli Lil­ly, which is de­signed to turn on a chem­i­cal switch to pro­duce new sen­so­ry hair cells from oth­er cells in the in­ner ear to im­prove hear­ing.

Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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Stephan Christgau, Amanda Hayward, Andreas Segerros and Magnus Persson (Eir Ventures)

A new ven­ture fund amid a pan­dem­ic? In the Nordics? Eir Ven­tures brings it on with €76M first close

From Pharmacia and Lundbeck to Novo Nordisk and AstraZeneca, the Nordic countries have been the birthplace for some legacy pharma companies. But for all that history and reputation, Stephan Christgau counts only five specialized life science investors backing biotechs today.

That leaves plenty of room for Eir Ventures, a brand new venture fund Christgau — one of the founders of Novo Seeds — is launching with three other veteran VCs.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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