Stanley Erck, Novavax CEO (Andrew Harnik, AP Images)

Covid-19 roundup: SAB's an­ti­body treat­ments move to PhI­II; Af­ter long jour­ney, No­vavax sub­mits vac­cine to WHO for re­view

A day af­ter the com­pa­ny lands an­oth­er $60.5 mil­lion to help ad­vance an an­ti­body Covid-19 treat­ment, SAB Bio­ther­a­peu­tics has an­nounced a pos­i­tive re­view from the Da­ta Mon­i­tor­ing Safe­ty Board, and will move in­to Phase III tri­als.

Both of the dos­es test­ed in a Phase II tri­al met the pre-tri­al ef­fi­ca­cy goals, the com­pa­ny says, though tri­al re­sults have not yet been post­ed to the clin­i­cal­tri­ web­site.

SAB-185 specif­i­cal­ly tar­gets poly­clon­al an­ti­bod­ies with­out the need for hu­man donors. While mon­o­clon­al an­ti­bod­ies use iden­ti­cal im­mune cells that are clones of a spe­cif­ic par­ent cell, poly­clon­al an­ti­bod­ies are made through sev­er­al dif­fer­ent im­mune cells. SAB-185 used ge­net­i­cal­ly en­gi­neered cat­tle to make an­ti­bod­ies.

The DSMB rec­om­mend­ed the move to Phase III for the treat­ment of non-hos­pi­tal­ized pa­tients with mild to mod­er­ate Covid-19. Phase III will com­pare the treat­ment to ac­tive mon­o­clon­al an­ti­body treat­ment in about 600 par­tic­i­pants. SAB is look­ing to bring the third FDA au­tho­rized an­ti­body treat­ment to the US, af­ter Re­gen­eron, Eli Lil­ly and GSK/Vir Biotech­nol­o­gy.

“Ad­vance­ment of SAB-185 to Phase 3 is a ma­jor mile­stone for our Di­ver­sitAb™ im­munother­a­py plat­form, which unique­ly pro­duces ful­ly-hu­man tar­get­ed poly­clon­al an­ti­bod­ies that have broad ap­plic­a­bil­i­ty to treat­ing oth­er in­fec­tious dis­eases and med­ical con­di­tions,” SAB CEO Ed­die Sul­li­van said in a press re­lease. “The re­cent pub­li­ca­tion of non­clin­i­cal da­ta demon­strat­ing SAB-185’s po­tent neu­tral­iza­tion of mul­ti­ple emerg­ing SARS-CoV-2 vari­ants pro­vid­ed ad­di­tion­al ev­i­dence that SAB-185 has the po­ten­tial to be­come a valu­able ther­a­py for mild to mod­er­ate COVID-19. We now look for­ward to the com­ple­tion of the Phase 3 tri­al and if suc­cess­ful, the op­por­tu­ni­ty to make SAB-185 wide­ly avail­able to the many COVID-19 pa­tients bat­tling this per­sis­tent and evolv­ing dis­ease.”

The poly­clon­al an­ti­body was de­vel­oped with the US gov­ern­ment us­ing the Di­ver­sitAb Rapid Re­sponse An­ti­body Pro­gram, as part of Op­er­a­tion Warp Speed. SAB says that in non­clin­i­cal stud­ies, the treat­ment has shown neu­tral­iza­tion of the Delta and Lamb­da strains.

SAB is set to merge with Big Cy­press Ac­qui­si­tion Corp. lat­er this year.

Af­ter long jour­ney, No­vavax sub­mits vac­cine to WHO for re­view

An­oth­er Covid-19 vac­cine has been sub­mit­ted to the World Health Or­ga­ni­za­tion to be re­viewed for emer­gency use list­ing.

No­vavax’s re­com­bi­nant nanopar­ti­cle pro­tein-based can­di­date, made in col­lab­o­ra­tion with The Serum In­sti­tute of In­dia, is head­ed to the reg­u­la­tors. The sub­mis­sion is based on the pre­vi­ous sub­mis­sion to In­di­an reg­u­la­tors. An OK from the WHO is a re­quire­ment to ex­port dos­es to the CO­V­AX vac­cine shar­ing pro­gram.

“To­day’s sub­mis­sion of our pro­tein-based COVID-19 vac­cine to WHO for emer­gency use list­ing is a sig­nif­i­cant step on the path to ac­cel­er­at­ing ac­cess and more eq­ui­table dis­tri­b­u­tion to coun­tries in great need around the world,” CEO Stan­ley Er­ck said in a press re­lease.

The an­nounce­ment comes af­ter the time­line for an FDA emer­gency use ap­proval has al­ready been pushed back sev­er­al times, most re­cent­ly with the biotech an­nounc­ing in its Q2 re­view that it would be in Q4. A New York Times re­port raised con­cerns sur­round­ing a note from the FDA stat­ing that the com­pa­ny’s man­u­fac­tur­ing fu­ture and the fund­ing that it was re­ceiv­ing from the US gov­ern­ment was de­pen­dent on get­ting its pro­duc­tion process to FDA stan­dards.

The com­pa­ny’s gone through some ups and downs dur­ing the pan­dem­ic, in­clud­ing land­ing $2 bil­lion in fund­ing, and man­u­fac­tur­ing strug­gles that led to oth­er com­pa­nies beat­ing them to the fin­ish line in the hunt for a vac­cine.

NVX-CoV2373 is cur­rent­ly in two Phase III tri­als, one of which demon­strat­ed 89% ef­fi­ca­cy against the virus and an­oth­er that sug­gest­ed 90% ef­fi­ca­cy.

In­dia to ship Sput­nik Light dos­es else­where

Sput­nik Light has yet to be ap­proved in In­dia, and the coun­try will like­ly ex­port its batch­es of the vac­cine pro­duced in-coun­try lat­er this month, Reuters re­ports.

In­di­an drug­mak­er Het­ero has al­ready man­u­fac­tured 2 mil­lion dos­es of the sin­gle-shot vac­cine, ac­cord­ing to Reuters. Sput­nik Light is the first of the two-shot Sput­nik V vac­cine that has been au­tho­rized in In­dia, and while Light has been ap­proved else­where, In­di­an reg­u­la­tors are hold­ing out for an­oth­er clin­i­cal tri­al.

So far, In­dia has ad­min­is­tered 907,766 Sput­nik V vac­cines out of the 839 mil­lion it’s giv­en out so far, Reuters said.

Cadi­la lands a man­u­fac­tur­ing part­ner

Shilpa Medicare Lim­it­ed will pro­duce Cadi­la’s three-dose Covid-19 vac­cine in In­dia, the com­pa­ny said Fri­day.

In­dia gave Cadi­la’s jab emer­gency ap­proval in Au­gust for adults and chil­dren above the age of 12. The com­pa­ny looks to make be­tween 100 mil­lion and 120 mil­lion dos­es a year.

The jab, dubbed Zy­CoV-D, is the world’s first Covid-19 DNA shot. Shilpa will make the drug sub­stance, and the vac­cine is set to be in sup­ply in Oc­to­ber.

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

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.

Siddhartha Mukherjee (Brian Ach/Getty Images for The New Yorker)

All Blue's $733M bid to ac­quire Zymeworks turns hos­tile as board bat­tles back — af­ter a biotech celebri­ty jumps in

Yesterday, the team at All Blue Capital — bent on the takeover of a badly battered Zymeworks — brought in celebrated oncologist, Pulitzer prize-winning writer and biotech exec Siddhartha Mukherjee to add some glitz to their proposed board. But they’re still not winning over any converts.

This morning, Zymeworks’ board officially turned this acquisition offer into a hostile showdown, rejecting the unsolicited offer and marshaling its forces to prevent a buyout at $10.50 per share.

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Paul Hudson, Sanofi CEO (via Getty)

Sanofi's $20B buy­out of Gen­zyme pays off again with Eu­ro­pean OK for first Nie­mann-Pick drug

Sanofi CEO Paul Hudson has made clear his intention to develop new rare disease drugs and broaden his company’s offerings. That effort leaped forward on Friday with the EMA’s signing off on the company’s — and the EU’s — first drug to treat the non-central nervous system manifestations of the rare and debilitating Niemann-Pick disease.

The enzyme replacement therapy, developed to replace patients’ deficient or defective enzyme, known as acid sphingomyelinase, was first developed by Genzyme, which Sanofi acquired for more than $20 billion in 2011. That acquisition has also helped Sanofi pull in sales in the field of MS.

Proac­tive­ly pre­vent­ing short­ages: New FDA guid­ance spells out which drugs re­quire risk man­age­ment plans

As the majority of drug shortages are still associated with manufacturing-related quality issues, the FDA on Thursday published new draft guidance spelling out how to proactively assess risks to manufacturing processes and supply chains, while understanding the market’s vulnerabilities.

While drug shortages peaked in 2011, the FDA says in its new 18-page draft guidance that the number of new drug shortages “has declined significantly since” that peak, reaching a low in 2015 and 2016, thanks in part to a new law’s enactment, known as FDASIA, which helped the agency better prevent or mitigate drug supply disruptions and shortages, and clarified cGMP requirements.