Glax­o­SmithK­line dou­bles down on Cure­Vac's mR­NA tech, bets $180M on the hunt for next-gen vac­cine

As new vari­ants high­light the pos­si­bil­i­ty that we will have to live with Covid-19 for­ev­er, Glax­o­SmithK­line is dou­bling down on its Cure­Vac part­ner­ship in search of an mR­NA vac­cine of the fu­ture.

And if it all goes smooth­ly, GSK might have a block­buster vac­cine all of its own in 2022.

Bankrolled with $180 mil­lion (€150 mil­lion) from GSK, the new co-de­vel­op­ment pact will see both com­pa­nies con­tribut­ing re­sources and ex­per­tise to­ward a num­ber of new mR­NA vac­cine can­di­dates — “in­clud­ing mul­ti-va­lent and mono­va­lent ap­proach­es.” €75 mil­lion of that is paid up­front and the rest is in mile­stones.

In ad­di­tion, the phar­ma gi­ant says it will lever­age a man­u­fac­tur­ing net­work in Bel­gium to sup­port Cure­Vac in the man­u­fac­ture of up to 100 mil­lion dos­es of its cur­rent shot in 2021, join­ing Bay­er in back­ing the biotech’s pro­duc­tion.

Even though the lead­ing mR­NA play­ers say their vac­cines are still able to pro­tect against new coro­n­avirus vari­ants emerg­ing in the UK, South Africa and Brazil, da­ta from them and oth­er de­vel­op­ers sug­gest they may not be as po­tent as they are against the orig­i­nal ver­sion of the virus that the vac­cines had been de­signed for.

GSK’s goal, it says in a state­ment, is to both cov­er those ex­ist­ing vari­ants while en­abling a quick re­sponse to any oth­ers that could pop up in the fu­ture. The next-gen vac­cine from the Cure­Vac plat­form is ex­pect­ed to reach the mar­ket in 2022, and GSK will be the own­er in most mar­kets ex­cept Ger­many, Aus­tria and Switzer­land.

Al­though Cure­Vac has fall­en sig­nif­i­cant­ly be­hind Pfiz­er/BioN­Tech and Mod­er­na in bring­ing a first-gen Covid-19 vac­cine to the mar­ket — with a Phase IIb/III tri­al still on­go­ing — GSK has pre­vi­ous­ly bet that its low­er dose, man­u­fac­tura­bil­i­ty and sta­bil­i­ty at stan­dard re­frig­er­a­tor con­di­tions can of­fer su­pe­ri­or so­lu­tions in oth­er in­fec­tious dis­eases.

The new deal sig­ni­fies the think­ing that Covid-19 vac­ci­na­tion won’t be a once and done mat­ter — even if the pan­dem­ic abates.

“We be­lieve that next gen­er­a­tion vac­cines will be cru­cial in the con­tin­ued fight against COVID-19,” GSK CEO Em­ma Walm­s­ley said.

Her com­pa­ny has stum­bled on a cou­ple bat­tles along the way. GSK jumped in­to the vac­cine hunt ear­ly by of­fer­ing its ad­ju­vant to re­searchers test­ing re­com­bi­nant pro­tein-based jabs, on­ly to run in­to a ma­jor de­lay with its big Sanofi col­lab­o­ra­tion and, more re­cent­ly, drop a sec­ond deal with Clover af­ter the Chi­nese part­ner opt­ed to take a dif­fer­ent ad­ju­vant in­to lat­er stages of test­ing.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Avid Bioser­vices, with re­cent IPO and Covid-19 part­ner­ship in hand, launch­es 2nd phase of fa­cil­i­ty ex­pan­sion

California’s Avid Bioservices now has two simultaneous expansion projects underway as the CDMO’s projections for customer demand sparked the launch this week of the second phase of building out its Myford facility.

Avid expects construction on the second phase, which will be known as its Myford South facility to take 18 to 24 months to complete at a cost of roughly $45 million to $55 million, it said in a press release.

Joe Biden (Credit: Doug Mills/The New York Times/Bloomberg via Getty Images)

Biden wants a re­view of the API sup­ply chain. Will that par­lay in­to an ef­fort to 'on­shore' drug man­u­fac­tur­ing?

When former President Donald J. Trump was voted out of office Nov. 2, his gung-ho effort to “onshore” drug manufacturing was left mostly up in the air. Joe Biden has been mostly mum on whether he would continue that effort, but a new executive order could provide a clue — at least in a few months.

In an order signed Wednesday, Biden demanded a 100-day governmental review of key supply chains, including for active pharmaceutical ingredients (API) used in American drugs.