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.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Andrew Phillips, Nexo Therapeutics CEO

Scoop: Ver­sant, NEA launch new biotech helmed by ex-CEO of pro­tein de­grad­er C4 Ther­a­peu­tics

Long-time biotech venture firms Versant and New Enterprise Associates are backing a new startup run by former C4 Therapeutics chief executive Andrew Phillips.

The fledgling biotech has raised at least $30 million so far, according to paperwork filed with the SEC this week. The round could balloon to $60 million.

Phillips, who left protein degradation startup C4 in 2020 to be a managing director at Cormorant Asset Management, is running the show of the new venture as president, the SEC filing outlines. He also served as interim CEO of Cormorant-backed and Hansoh Pharmaceutical-partnered Blossom Bioscience last year.

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J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.