Covid-19 roundup: An old, cheap steroid proves to be a ma­jor boon to coro­n­avirus pa­tients; BAR­DA puts $85M be­hind Re­gen­eron an­ti­body ef­fort

Re­searchers to­day spot­light­ed da­ta from a clin­i­cal study of­fer­ing the first hard ev­i­dence that a treat­ment can save the lives of pa­tients suf­fer­ing from Covid-19.

The old gener­ic dex­am­etha­sone was tied to a one-third re­duc­tion of deaths among ven­ti­lat­ed pa­tients with a one-fifth re­duc­tion in mor­tal­i­ty among a group get­ting oxy­gen. There was no ben­e­fit for pa­tients who did not re­quire res­pi­ra­to­ry as­sis­tance.

“Dex­am­etha­sone is the first drug to be shown to im­prove sur­vival in COVID-19,” not­ed Pe­ter Hor­by, an Ox­ford pro­fes­sor and a chief in­ves­ti­ga­tor in the tri­al. “This is an ex­treme­ly wel­come re­sult. The sur­vival ben­e­fit is clear and large in those pa­tients who are sick enough to re­quire oxy­gen treat­ment, so dex­am­etha­sone should now be­come stan­dard of care in these pa­tients. Dex­am­etha­sone is in­ex­pen­sive, on the shelf, and can be used im­me­di­ate­ly to save lives world­wide.”

“(I)t is fan­tas­tic that the first treat­ment demon­strat­ed to re­duce mor­tal­i­ty is one that is in­stant­ly avail­able and af­ford­able world­wide,” en­thused Ox­ford’s Mar­tin Lan­dray. — John Car­roll

BAR­DA puts $85M be­hind Re­gen­eron’s an­ti­body ef­fort

BAR­DA, the US biode­fense agency, is back­ing Re­gen­eron’s Covid-19 an­tivi­ral an­ti­body ef­fort with $85 mil­lion.

Al­though BAR­DA has al­ready promised over $2 bil­lion to ac­cel­er­ate and scale the de­vel­op­ment of Covid-19 vac­cines, but this is the largest tranche of fund­ing yet for a treat­ment ef­fort. BAR­DA worked with Re­gen­eron on their Ebo­la an­ti­body ef­fort – help­ing lead to one of the first two suc­cess­ful treat­ments for the virus in a tri­al last Au­gust – and the pair first an­nounced col­lab­o­ra­tion on a sim­i­lar ef­fort for Covid-19 in Feb­ru­ary.

The news of the fund­ing comes days af­ter Re­gen­eron put their first cock­tail of an­ti­bod­ies in the clin­ic. The Tar­ry­town-based biotech plans to even­tu­al­ly run 4 tri­als, 2 of them test­ing the drug as a treat­ment and 2 as a pro­phy­lac­tic.

HHS has al­so fund­ed an­ti­body ef­forts from As­traZeneca and SAb Bio­ther­a­peu­tics. Roche and J&J, among oth­ers, have re­ceived fund­ing for oth­er types of treat­ment. — Ja­son Mast

Pe­ter Kolchin­sky of­fers Covid-19 play­er No­vavax a thumbs up and $200M 

RA Cap­i­tal’s Pe­ter Kolchin­sky is back­ing No­vavax’s Covid-19 play, to the tune of $200 mil­lion.

A fund af­fil­i­at­ed with RA is buy­ing 4.4 mil­lion shares of stock $NVAX in the com­pa­ny at the June 12 clos­ing price.

Covid-19 has been a big help for No­vavax, which has had its share of clin­i­cal fail­ures to deal with. CEPI stepped up with its largest com­mit­ment to date, back­ing the biotech’s Phase I and Phase II tri­als for NVX-CoV2373 for up to $384 mil­lion while “dra­mat­i­cal­ly” in­creas­ing its pro­duc­tion ca­pac­i­ty for the vac­cine anti­gen as well as the ad­ju­vant need­ed to boost its ef­fi­ca­cy. That mon­ey was added on top of the $4 mil­lion CEPI sent No­vavax to get things go­ing in R&D with­out any de­lays for ne­go­ti­a­tions.

“The glob­al vac­cine ef­fort is search­ing for can­di­dates that are ca­pa­ble of both gen­er­at­ing the high­est neu­tral­iz­ing an­ti­body titers and large-scale pro­duc­tion. We are ex­cit­ed to in­crease our in­vest­ment in No­vavax, which along with re­sources from CEPI and the U.S. De­part­ment of De­fense, will sup­port No­vavax in its im­por­tant work de­vel­op­ing an ef­fec­tive, scal­able vac­cine for SARS-CoV-2,” said Kolchin­sky in a state­ment. — John Car­roll

Sanofi sets aside $679M cash for new vac­cine sites in France

As Sanofi push­es its par­al­lel R&D ef­forts on a pair of Covid-19 vac­cine can­di­dates, the French drug­mak­er said it would pour $679.4 mil­lion (€610 mil­lion) in­to two vac­cine sites on its home turf.

The com­mit­ment to “make France its world class cen­ter of ex­cel­lence” comes just weeks af­ter CEO Paul Hud­son, a Brit, drew the ire of French min­is­ters by say­ing in an in­ter­view that the US gov­ern­ment “has the right to the largest pre-or­der be­cause it’s in­vest­ed in tak­ing the risk” — a com­ment Sanofi swift­ly walked back.

“Sanofi’s heart beats in France,” Hud­son said in a pre­pared state­ment. “Sanofi is a ma­jor health­care play­er in France, in Eu­rope, and world­wide. It is our re­spon­si­bil­i­ty to fo­cus our re­sources and ex­per­tise against the cur­rent pan­dem­ic, but al­so to in­vest in prepar­ing for fu­ture ones.”.

French au­thor­i­ties have been work­ing with Sanofi the last sev­er­al months to achieve this, he added, in a com­ment that echoed Ger­many’s de­ci­sion to buy a stake of mR­NA biotech Cure­Vac with €300 mil­lion in fed­er­al mon­ey. And Pres­i­dent Em­manuel Macron came through with a pledge of €200 mil­lion to fu­el do­mes­tic re­search and man­u­fac­tur­ing, a boost Hud­son has been ad­vo­cat­ing for.

“Every­body saw that dur­ing this cri­sis some com­mon­ly used drugs were no longer pro­duced in France and Eu­rope. So we must no longer just ask ques­tions, but draw the con­clu­sions,” Macron said at Sanofi’s Mar­cy-L’Étoile fa­cil­i­ty.

At the same time — and it might have been drowned out by the Syn­thorx buy­out and dra­mat­ic cuts in the car­dio and di­a­betes units — the com­pa­ny re­mind­ed read­ers of the press re­lease that vac­cines were iden­ti­fied as a key area for growth in the cor­po­rate strat­e­gy Hud­son laid out last year.

Sanofi plans to build a vac­cine pro­duc­tion site at Neuville-sur-Saône and a re­search cen­ter at Mar­cy-l’Étoile, cre­at­ing a whole chain from R&D to man­u­fac­tur­ing with­in the coun­try.

The for­mer fa­cil­i­ty will cost an es­ti­mat­ed €490 mil­lion over five years and is ex­pect­ed to cre­ate 200 new jobs. The lat­ter will fo­cus on de­vel­op­ing fu­ture vac­cines, with high­ly-spe­cial­ized labs fo­cused on emerg­ing dis­eases and pan­dem­ic risks. — Am­ber Tong

Im­pe­r­i­al Col­lege of Lon­don preps Phase I tri­al of mR­NA vac­cine

A new mR­NA vac­cine ef­fort is en­ter­ing the clin­ic.

Three months af­ter Mod­er­na be­gan hu­man Covid-19 vac­cine test­ing with an mR­NA can­di­date, a can­di­date based on sim­i­lar tech­nol­o­gy from the Im­pe­r­i­al Col­lege of Lon­don will go in­to an ear­ly-stage tri­al this week, Reuters re­port­ed.

Un­like vir­tu­al­ly every oth­er clin­i­cal-stage Covid-19 vac­cine, the Im­pe­r­i­al Col­lege does not have a ma­jor in­dus­try part­ner. In­stead they’ve re­ceived over $56.5 mil­lion in fund­ing from par­lia­ment and donors, and have set up a new ven­ture for com­mer­cial­iz­ing the vac­cine should it prove safe and ef­fec­tive.

Al­though sim­i­lar in prin­ci­ple to Mod­er­na’s can­di­date — putting the ge­net­ic code for a coro­n­avirus pro­tein in­to hu­man cells, which ex­press the pro­tein and trig­ger an im­mune re­sponse — the col­lege’s tech­nol­o­gy dif­fers in key ways. Called small-am­pli­fy­ing RNA, the ge­net­ic code in the vac­cine will repli­cate it­self in­side cells, al­low­ing for much small­er dos­es and thus a po­ten­tial­ly much broad­er scale. It was de­vel­oped in part by Robin Shat­tock, who has al­so de­signed the Covid-19 can­di­date.

To com­mer­cial­ize the vac­cine, the col­lege set up a new com­pa­ny called VacE­quity Glob­al Health with the Hong Kong-based in­vest­ment firm Morn­ing­side Ven­tures. Its goal will be to make the vac­cine as wide­ly avail­able as pos­si­ble, while still turn­ing a prof­it — pos­si­bly by sell­ing for slight­ly high­er prices in high-in­come than low-in­come coun­tries.

The vac­cine will be one of sev­er­al that en­ter the clin­ic in the com­ing weeks and months. Cure­Vac, one of the first biotechs to be­gin de­vel­op­ing a vac­cine and which al­so us­es mR­NA, said ear­ly in the pan­dem­ic that they would aim for tri­als in June. And to­day sci­en­tists in Sin­ga­pore said they would be­gin test­ing an mR­NA vac­cine from the US biotech Arc­turus in Au­gust. — Ja­son Mast

As­traZeneca re­veals more of man­u­fac­tur­ing plan, adds an­oth­er part­ner

The streak of man­u­fac­tur­ing and sup­ply deals As­traZeneca has struck for Ox­ford’s Covid-19 vac­cine, cou­pled with rapid progress on the clin­i­cal front, ap­pears to have em­bold­ened the com­pa­ny in di­al­ing up its hopes, with CEO Pas­cal So­ri­ot pre­dict­ing that the pro­tec­tion would last for about a year, as re­port­ed by Reuters.

Un­der ide­al cir­cum­stances — which would in­volve enough vol­un­teers giv­en place­bo get in­fect­ed by the coro­n­avirus — re­sults of the on­go­ing Phase III tri­als will be ready in Au­gust or Sep­tem­ber.

“We are man­u­fac­tur­ing in par­al­lel,” he added. “We will be ready to de­liv­er from Oc­to­ber if all goes well.”

Through a glob­al net­work of part­ners, As­traZeneca said it’s se­cured ca­pac­i­ty for 2 bil­lion dos­es through 2021. A grow­ing list of part­ners have re­served more than half of that col­lec­tive­ly: 400 mil­lion dos­es for Eu­rope in its lat­est deal with France, Ger­many, Italy and the Nether­lands; 300 mil­lion for the US; 100 mil­lion for the UK; and 400 mil­lion to low- and mid­dle-in­come coun­tries by the end of the year.

On Tues­day the phar­ma gi­ant added Co­bra Bi­o­log­ics to the con­trac­tor fold, task­ing the UK man­u­fac­tur­er with pro­vid­ing GMP man­u­fac­ture of the vac­cine can­di­date AZD1222.

Co­bra had be­gun work­ing with Ox­ford’s Jen­ner In­sti­tute in March, be­fore As­traZeneca jumped on board with its pow­er­house in­fra­struc­ture. The sci­en­tists who de­vel­oped the re­com­bi­nant ade­n­ovirus vec­tor im­mu­niza­tion were think­ing about mass pro­duc­tion ear­ly on; some of the com­pa­nies that they had tapped for their man­u­fac­tur­ing con­sor­tium, such as Ox­ford Bio­med­ica, have since teamed up with As­traZeneca.

“The agree­ment with As­traZeneca comes at an op­por­tune time for us as we bring three ad­di­tion­al vi­ral vec­tor suites on­line as part of our on­go­ing ad­vanced ther­a­pies ex­pan­sion pro­gramme,” Pe­ter Cole­man, chief ex­ec­u­tive at Co­bra, said in a state­ment. — Am­ber Tong

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.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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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.

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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J&J ad­comm live blog: Com­mit­tee votes 22-0 to rec­om­mend an FDA OK for the J&J vac­cine, set­ting up 3rd US Covid-19 jab

The US could have a third authorized Covid-19 vaccine within hours.

The FDA’s advisory committee voted unanimously — 22-0 — to recommend the agency issue an emergency use authorization for J&J’s vaccine. If they follow the precedent of the Pfizer and Moderna vaccine,  the FDA will likely authorize the vaccine by Saturday, immediately adding a few million doses to the US supply and adding a 100 million by June. An authorization would give the world its first single-dose vaccine, a major weapon in the effort to vaccinate the world and bring the virus to heel, particularly in rural and developing areas.

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.

Covid-19 roundup: US se­cures 100,000 dos­es of Eli Lil­ly's an­ti­body cock­tail; Mer­ck­'s $356M sup­ply deal on hold as FDA asks for more da­ta

A couple weeks after racking up its third EUA for a Covid-19 treatment — this one for its antibody cocktail — Eli Lilly has struck a deal with the US government for at least 100,000 doses.

The US will pay $210 million for doses of bamlanivimab and etesevimab, which will be delivered through March 31, Lilly said in a statement. The deal builds on 1.45 million doses of bamlanivimab alone that the US has already purchased, more than 1 million of which have been delivered. Another 450,000 doses of the single antibody are also expected to arrive by March 31.

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With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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