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.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

A T-cell play­er with back­ing from Roche takes next big step for BiTE drugs with 'on-of­f' switch to avoid tox­i­c­i­ty

The bispecific T cell engager field is absolutely packed with big-name players who have crowded in despite some high-profile failures in the class. Now, a Bay Area biotech thinks it may have the key to tackling BiTE toxicity, using an old “on-off switch” idea to give doctors more control of the drugs’ effect on patients.

San Francisco-based Soteria Biotherapeutics uncloaked Monday with a $42 million Series A co-led by Roche Venture Fund and 5AM Ventures with participation from the Novartis Venture Fund to advance its bispecific T cell engagers with an “on-off” switch the founders think can avoid some of the dire safety flags endemic to the class.

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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