Oxford professor Adrian Hill (Eddie Keogh/Reuters via Alamy)

The com­pa­ny be­hind As­traZeneca's Covid-19 vac­cine just went pub­lic, weeks af­ter com­plet­ing mon­ster Se­ries B, as Were­wolf al­so makes the Nas­daq leap

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The com­pa­ny be­hind the tech­nol­o­gy for As­traZeneca’s Covid-19 vac­cine is prepped and ready to hit Nas­daq.

British biotech Vac­citech priced its IPO late Thurs­day night, pulling in a $110.5 mil­lion raise and will de­but at the mid­point of their range at $17. It’s a quick pub­lic leap for the com­pa­ny, hav­ing com­plet­ed a Se­ries B just last month — though that crossover proved to be huge at $168 mil­lion.

Once Vac­citech be­gins trad­ing, it will do so on the tick­er $VACC.

Sarah Gilbert

For­mer­ly a small biotech that spun out of Ox­ford in 2016, Vac­citech has seen its pro­file ex­pand sharply over the course of the Covid-19 pan­dem­ic. The com­pa­ny was found­ed on re­search from vac­ci­nol­o­gists Adri­an Hill and Sarah Gilbert, with Gilbert orig­i­nal­ly look­ing to raise funds for a po­ten­tial MERS vac­cine, per a Ju­ly 2020 Busi­ness­week re­port.

The pro­gram even­tu­al­ly proved fruit­ful in their ef­forts to de­vel­op a Covid-19 shot, as the spike pro­teins from the two virus­es are about 50% sim­i­lar. Gilbert al­so uti­lized the same plat­form as the MERS can­di­date to make their Covid-19 vac­cine, which is cen­tered around a chim­panzee ade­n­ovirus.

At the out­set of the pan­dem­ic, Gilbert and Hill at­tempt­ed to en­sure their vac­cine would be made avail­able glob­al­ly and fought against a li­cens­ing agree­ment with Mer­ck out of fear the Big Phar­ma wouldn’t pro­vide it to poor­er na­tions at fair cost. They ul­ti­mate­ly changed course, prompt­ed by the Bill and Melin­da Gates Foun­da­tion, and part­nered ex­clu­sive­ly with As­traZeneca.

With the deal in hand, Vac­citech and As­traZeneca proved one of the ear­ly fron­trun­ners in the Covid-19 vac­cine race. Through­out last sum­mer, the pair had sailed smooth­ly from ear­ly tri­als in­to late-stage stud­ies, launch­ing their large-scale Phase III in the US just af­ter the teams from Mod­er­na and Pfiz­er/BioN­Tech last Sep­tem­ber.

But, just days lat­er, As­traZeneca was forced to pause its tri­als af­ter a par­tic­i­pant de­vel­oped what was thought to be se­vere spinal cord in­flam­ma­tion, a con­di­tion that can be caused by a va­ri­ety of trig­gers. The phar­ma on­ly got FDA per­mis­sion to re­sume in late Oc­to­ber, in part be­cause they were slow to share in­for­ma­tion with the reg­u­la­tor. It had restart­ed tri­als else­where ear­li­er, al­though things have been bumpy since.

As­traZeneca has been mired in fights over dis­tri­b­u­tion to Eu­rope as the cal­en­dar turned to 2021, with de­lays and ac­cu­sa­tions of re­neged promis­es ul­ti­mate­ly lead­ing to the EU su­ing the phar­ma ear­li­er this week.

Vac­citech, though, is ready to cash in on the heels of its Covid-19 pro­gram. Their Se­ries B was joined by promi­nent in­vestors M&G, Gilead and Ten­cent, among oth­ers. With­in the S-1, Vac­citech plans to com­plete clin­i­cal tri­als in he­pati­tis B and HPV pro­grams, and start a Phase I/II study for an­oth­er can­di­date in prostate can­cer. Fur­ther down the pipeline, funds will go to an NSCLC pro­gram and two pro­grams to pre­vent zoster and MERS.

As re­cent­ly as 2019, Vac­citech was val­ued at on­ly $86 mil­lion. But their Se­ries B raised spec­u­la­tion that they could notch a $1 bil­lion val­u­a­tion by the time their IPO rolled around, a the­o­ry that ul­ti­mate­ly over­shot that es­ti­mate — ac­cord­ing to Re­nais­sance Cap­i­tal, Vac­citech’s mar­ket val­ue is $614 mil­lion.

The move to Nas­daq is al­so seen by some in the UK as a loss for British prime min­is­ter Boris John­son, who has been try­ing to mar­ket the coun­try as a bur­geon­ing life sci­ences hub in the wake of Brex­it.

Were­wolf howls its way on­to Nas­daq

Join­ing Vac­citech in the Nas­daq pa­rade is Were­wolf Ther­a­peu­tics, who priced their IPO at $16 per share and net­ted a $120 mil­lion raise.

The com­pa­ny has de­vel­oped three mol­e­cules be­long­ing to a class they dub In­dukines, which com­pris­es four com­po­nents: a cy­tokine, an in­ac­ti­va­tion do­main, a half-life ex­ten­sion do­main and a link­er that can be cleaved by pro­teas­es found in tu­mors. Were­wolf says the com­bi­na­tion can lay low through­out the body, wait­ing to strike specif­i­cal­ly against can­cer tar­gets.

Like Vac­citech, Were­wolf al­so re­cent­ly com­plet­ed a Se­ries B round, hav­ing raised $72 mil­lion back in Jan­u­ary. With an ini­tial fo­cus on IL-2 and IL-12, Were­wolf is look­ing to be­gin hu­man test­ing for WTX-124 and WTX-330 in 2022. The third can­di­date aims to con­di­tion­al­ly ac­ti­vate IFN-a.

With the pair go­ing pub­lic Fri­day, the to­tal biotech IPO raise is near­ing $6.5 bil­lion among the 39 com­pa­nies to de­but so far, per the End­points News tal­ly. Were­wolf plans to trade un­der the tick­er $HOWL.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

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Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

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Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.