James Porter, Nuvalent CEO

Nu­va­lent joins the IPO par­ty less than 6 months af­ter launch, while Icosavax kicks its 'soc­cer bal­l' VLPs to Nas­daq

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Less than six months af­ter emerg­ing from stealth, the Deer­field-backed biotech Nu­va­lent is al­ready prep­ping a jump to Nas­daq. And it’s a leap that could prove high­ly prof­itable for the blue chip firm.

Nu­va­lent filed its S-1 pa­per­work Wednes­day, pen­cil­ing in the $100 mil­lion raise es­ti­mate that’s be­come com­mon­place dur­ing the IPO boom of the last 15 or so months. The fi­nal fig­ure may end up high­er giv­en the biotech’s crossover raise in May hit the $135 mil­lion mark, but even if it falls short, it’s a rapid as­cent for Nu­va­lent af­ter its Jan­u­ary de­but.

It’s al­so a big win for Deer­field, which placed a big wa­ger on the com­pa­ny ear­li­er this year. Deer­field helped launch Nu­va­lent to the tune of a $50 mil­lion Se­ries A and cur­rent­ly owns more than 65% of shares.

Nu­va­lent got start­ed based on solv­ing a prob­lem that can some­times oc­cur in tar­get­ed can­cer ther­a­pies, where the tar­get is al­ways chang­ing. Even though new­er gen­er­a­tions of drugs can ap­pear to hit the tar­get, mu­ta­tions will usu­al­ly pop up that thwart the ther­a­pies from ac­com­plish­ing their mis­sions.

Matt Shair

Har­vard pro­fes­sor Matt Shair, founder and head sci­en­tif­ic ad­vi­sor of Nu­va­lent, be­lieves chem­istry can evolve fast enough to keep pace with the dis­eases, he told End­points News in Jan­u­ary. While in stealth, he pushed the biotech to uti­lize struc­ture-based drug de­sign to de­vel­op two com­pounds that tar­get the tu­mor dri­vers ROS1 and ALK for the clin­ic.

That ap­proach, Shair said, is com­ple­ment­ed with Nu­va­lent’s ef­forts to seek out physi­cian in­put for what kinds of prop­er­ties they want in a drug.

Both pro­grams have yet to reach their first in-hu­man stud­ies, but IPO funds are ex­pect­ed to help launch Phase I por­tions of planned Phase I/II stud­ies for each can­di­date and push them through to com­ple­tion. Some of the cash will al­so be ear­marked for pre­clin­i­cal pro­grams tar­get­ing ALK, IXDN and HER2 Ex­on 20 In­ser­tions.

In ad­di­tion to Deer­field, Bain Cap­i­tal al­so owns a sig­nif­i­cant chunk of the com­pa­ny, clock­ing in at 7.3%. Fi­deli­ty Man­age­ment has a 6.1% stake, while Shair him­self owns 6.5% of shares. CEO James Porter has tak­en home a mod­est 1%.

When Nu­va­lent goes pub­lic, it will trade un­der the tick­er $NU­VL.

Icosavax kicks its ‘soc­cer ball’ VLPs to Nas­daq

Icosavax al­so filed its S-1 pa­per­work Wednes­day with a $100 mil­lion place­hold­er fig­ure, aim­ing to kick its VLP plat­form to the pub­lic sec­tor.

Neil King

The tech­nol­o­gy comes out of Neil King’s lab at the Uni­ver­si­ty of Wash­ing­ton, where his team built on years-old re­search of how some vi­ral pro­teins could spon­ta­neous­ly as­sem­ble them­selves. Their work re­sult­ed in what’s es­sen­tial­ly a virus-like par­ti­cle shaped like a soc­cer ball — the “white” parts mak­ing up the struc­ture and the “black” spots rep­re­sent­ing the dis­played anti­gens, King told End­points in April.

It’s the same tech King is us­ing to de­vel­op a “su­per-sea­son­al” flu vac­cine with the NIH, though Icosavax is not in­volved in that re­search.

The biotech’s bi­va­lent vac­cine pro­gram, which will soak up most of the IPO cash, is go­ing af­ter res­pi­ra­to­ry syn­cy­tial virus and hu­man metap­neu­movirus. Icosavax’s plan is to start with the RSV “soc­cer ball” and then lay­er the hM­PV vac­cine on top of it as the new funds will help com­plete a Phase IIb study for the pro­gram.

Adam Simp­son

It’s not yet clear when the da­ta from this can­di­date will be ready, how­ev­er, as it’s not ex­pect­ed to be­gin a Phase I study un­til the sec­ond half of 2022. Oth­er IPO funds will be di­rect­ed to­ward the biotech’s Covid-19 vac­cine, with Icosavax look­ing to wrap up a Phase I/II tri­al thanks to the in­com­ing wind­fall.

Five dif­fer­ent firms hold stakes in Icosavax that range be­tween 10.8% and 13% — RA Cap­i­tal Man­age­ment, Qim­ing, Adams Street Part­ners, Aven­tis and Nan­oDi­men­sion. Chair Tadata­ka Ya­ma­da owns 4.8%, CEO Adam Simp­son has a 3.1% stake and CSO Doug Holtz­man clocks in at 1.2%.

When Icosavax goes pub­lic, it will trade un­der the tick­er $ICVX.

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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