Vac­citech con­fi­den­tial­ly files for Nas­daq IPO — re­port; Sanofi recom­mits to so­cial caus­es, launch­es glob­al non­prof­it

An­oth­er biotech is re­port­ed­ly head­ed to Nas­daq, one that plays a promi­nent role in the Covid-19 vac­cine race.

Com­ing from the shores of Britain, Vac­citech con­fi­den­tial­ly filed for an IPO on Wednes­day, per a re­port from the Fi­nan­cial Times. The com­pa­ny hasn’t filed any pa­per­work with the SEC just yet, and it’s un­clear what kind of raise they’re es­ti­mat­ing. FT not­ed that the com­pa­ny could price as ear­ly as this month, how­ev­er.

Sarah Gilbert

Vac­citech is the biotech be­hind the As­traZeneca/Ox­ford Uni­ver­si­ty Covid-19 vac­cine, own­ing the tech­nol­o­gy that drove the shot’s de­vel­op­ment. Its co-founder, Sarah Gilbert, al­so led the re­search in­to the vac­cine.

Just a few weeks ago, Vac­citech pulled in a mon­ster $168 mil­lion Se­ries B, led by Lon­don in­vest­ment firm M&G and joined by Gilead and Ten­cent, among oth­ers. Val­ued as lit­tle as $86 mil­lion back in 2019, Vac­citech is now val­ued at over $450 mil­lion thanks to the March raise. The com­pa­ny had orig­i­nal­ly been work­ing on a MERS vac­cine, which they then used as a pi­lot pro­gram for the Covid-19 re­search.

IPO cash has been flow­ing in­to biotech over the last 12 months, with 2020 record­ing a record raise for the sec­tor. That’s on­ly con­tin­ued through the first quar­ter of 2021, with more than two dozen com­pa­nies rais­ing a com­bined $4.64 bil­lion so far.

But op­ti­mism for Vac­citech may be lim­it­ed as con­cerns linger over the As­traZeneca/Ox­ford vac­cine. The Big Phar­ma paused its vac­cine tri­al in chil­dren Tues­day as reg­u­la­tors con­tin­ue to look in­to a pos­si­ble link be­tween the shot and blood clot events.

Sanofi launch­es glob­al non­prof­it as part of new so­cial push

Sanofi is ex­pand­ing its so­cial com­mit­ments and cre­at­ing a new non­prof­it to de­liv­er es­sen­tial med­i­cines to poor­er na­tions, CEO Paul Hud­son an­nounced in an open let­ter Wednes­day.

Paul Hud­son

The non­prof­it, to be called Sanofi Glob­al Health, is aimed at in­creas­ing ac­cess to med­i­cines con­sid­ered es­sen­tial by the WHO for pa­tients in 40 low­er in­come coun­tries. 30 of Sanofi’s ther­a­peu­tics will be pro­vid­ed across a range of dis­eases, in­clud­ing car­dio­vas­cu­lar dis­ease, di­a­betes, tu­ber­cu­lo­sis, malar­ia and can­cer.

Sanofi Glob­al Health will al­so help train health­care pro­fes­sion­als and set up and de­vel­op sus­tain­able care sys­tems for those who suf­fer from chron­ic dis­eases. Sanofi says this is the first ef­fort of its kind to pro­vide as broad a port­fo­lio as de­tailed in Hud­son’s let­ter.

In ad­di­tion to the non­prof­it, Sanofi is al­so recom­mit­ting to in­crease di­ver­si­ty with­in its work­force and elim­i­nate plas­tic pack­ag­ing for vac­cines and oth­er prod­ucts.

“Through­out this pan­dem­ic, pub­lic au­thor­i­ties, sci­en­tists, and in­dus­try have worked close­ly to­geth­er to dis­cov­er and pro­duce vac­cines at a pace that has de­fied his­tor­i­cal prece­dent,” Hud­son wrote. “We now have to ap­ply this same sense of ur­gency to oth­er press­ing threats, such as cli­mate change, and is­sues that the pan­dem­ic has sharply put in­to fo­cus, in­clud­ing widen­ing racial and health­care in­equal­i­ties.”

Tysabri in­jec­tions OK’ed in Eu­rope

Bio­gen ex­pand­ed its Tysabri fran­chise in Eu­rope on Wednes­day, win­ning a new ap­proval from the Eu­ro­pean Com­mis­sion to treat re­laps­ing-re­mit­ting mul­ti­ple scle­ro­sis through sub­cu­ta­neous in­jec­tion.

The new ad­min­is­tra­tion method com­pares sim­i­lar­ly in both safe­ty and ef­fi­ca­cy to Tysabri’s IV for­mu­la­tion, Bio­gen said in its an­nounce­ment. The com­pa­ny says it’s now the on­ly high-ef­fi­ca­cy MS ther­a­py to of­fer two dif­fer­ent ad­min­is­tra­tion op­tions.

Like the IV in­fu­sion, the Tysabri in­jec­tions are dosed at 300 mg every four weeks by a health­care provider. The aim of the new method is to ex­pand the clin­i­cal set­tings in which pa­tients can be treat­ed be­yond in­fu­sion cen­ters, es­pe­cial­ly with the Covid-19 pan­dem­ic still in full swing.

Tysabri was orig­i­nal­ly ap­proved in Eu­rope back in 2006.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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Av­enue Ther­a­peu­tics lands an FDA ad­comm for trou­bled flag­ship drug; FDA ap­proves eye in­jec­tion treat­ment for flu­id buildup

Intravenous tramadol-focused Avenue Therapeutics may not be out of the game just yet.

After receiving two CRLs for their drug, Avenue announced today that it has received a written interim response from the FDA’s Office of New Drugs that regulators will hold an adcomm to reach a decision on a formal dispute resolution request filed by Avenue back in July.

This occurred after the FDA sent Avenue the second CRL for their drug, an intravenous form of synthetic opioid tramadol.

AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.