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 clin­i­cal­tri­als.gov 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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

David Kessler testifies during a Senate hearing in May (Jim Lo Scalzo/Pool via AP Images)

Biden's fight with Mod­er­na over pro­vid­ing vac­cines for the poor­est coun­tries in­ten­si­fies

With about $10 billion in taxpayer funds invested in Moderna so far, it would seem that the company would be more understanding of pleas from President Joe Biden and the federal government to provide more vaccine doses to low- and middle-income countries.

But the Biden-Moderna feud over supplying the world with doses of mRNA vaccines is now spilling into the public, with Biden’s chief science officer of the government’s Covid-19 response David Kessler explaining the details in an online panel discussion moderated by Yale law professor Amy Kapczynski on Wednesday.

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