Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Ther­a­peu­tics start­ed out last April with a mod­est $50 mil­lion to mine tar­get­ed mus­cle dis­ease ther­a­pies from its in-house con­ju­gate tech­nol­o­gy. The biotech has now con­vinced more in­vestors that it’s got gems on its hands, clos­ing $115 mil­lion in fresh fi­nanc­ing to push its next-gen oligonu­cleotide drugs in­to the clin­ic.

Joshua Brumm

Vi­da Ven­tures and Sur­vey­or Cap­i­tal led the round, joined by a group of oth­er new back­ers in­clud­ing Welling­ton Man­age­ment Com­pa­ny, Lo­gos Cap­i­tal and Franklin Tem­ple­ton.

At­las — where Dyne was in­cu­bat­ed — al­so re­turned along­side For­bion and MPM.

Ste­fan Vi­torovic, who co-found­ed Vi­da with Arie Bellde­grun and oth­ers, took the lead on this one. Dyne’s FORCE plat­form match­es ex­act­ly their ap­petite for bold vi­sions in the fu­ture of med­i­cine, with the po­ten­tial to de­liv­er “life-chang­ing out­comes” for pa­tients with mus­cle dis­eases, he said.

This is how the biotech plans to do it: By link­ing an an­ti­body to an oligonu­cleotide, Dyne’s ther­a­pies are en­gi­neered to hone in on mus­cle cells and de­grade on­ly dis­ease-caus­ing RNA, there­by avoid­ing sys­temic tox­i­c­i­ty is­sues.

Ro­mesh Sub­ra­man­ian

Ro­mesh Sub­ra­man­ian, a co-founder of what is now Trans­late Bio, helped launch the op­er­a­tions as an en­tre­pre­neur-in-res­i­dence at At­las. He’s since hand­ed the CEO ba­ton to Joshua Brumm and moved to the CSO post.

“When you de­liv­er a naked oli­go, very lit­tle gets to the mus­cle,” he told C&EN back in 2019.

That means a lack of speci­fici­ty and po­ten­tial safe­ty prob­lems for drugs like Sarep­ta’s con­tro­ver­sial Ex­ondys 51. While Dyne is aim­ing di­rect­ly at that mar­ket with its Duchenne mus­cu­lar dy­s­tro­phy pro­gram, its ini­tial fo­cus is on my­oton­ic dy­s­tro­phy.

Trail­ing close­ly is a third ther­a­py for fa­cioscapu­lo­humer­al mus­cu­lar dy­s­tro­phy, fol­lowed by dis­cov­ery work in the car­diac and meta­bol­ic are­nas.

Su­san­na High

How would the ap­proach com­pare to gene ther­a­pies, which are crop­ping up at Sarep­ta and oth­er new­er play­ers fo­cused on mus­cle dis­eases? We didn’t get a chance to ask Dyne, which is shy­ing away from in­ter­views this morn­ing — per­haps a sign of up­com­ing plans in a boom­ing biotech IPO mar­ket.

Un­der Brumm, Dyne has been on a bit of a hir­ing spree re­cent­ly, poach­ing Su­san­na High from blue­bird to be COO, ap­point­ing ex-Cel­gene ex­ec Daniel Wil­son as VP of in­tel­lec­tu­al prop­er­ty, and scoop­ing De­bra Feld­man from Sage Ther­a­peu­tics as head of reg­u­la­to­ry.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

A handful of biotechs are hitting Wall Street just before the start of the weekend, with three companies — Caribou Biosciences, Sophia Genetics and Absci — all pricing big raises Wednesday and Thursday. Gamma delta T cell-focused IN8bio relaunched its IPO campaign months after postponing it last November, seeking a slightly lower raise. And another SPAC has filed for a public debut.

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Victor Perlroth, Kodiak Sciences CEO

Ko­di­ak turns down $125M pay­ment from Bak­er Bros. deal, slash­es roy­al­ty cap by 55%

Following a massive public raise last November, Kodiak Sciences has re-worked a royalty sale agreement with an old partner — and declined new funds in the process.

Kodiak is turning down a planned $125 million payment from Baker Bros. Advisors, according to an SEC filing, cutting short an agreement that saw the biotech hand over a 4.5% stream of royalty sales on its experimental anti-VEGF therapy KSI-301 for retinal vascular diseases. In conjunction with the move, Kodiak is shrinking the royalty cap from just over $1 billion to $450 million.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

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