Covid-19 roundup: Re­gen­eron nabs pri­or­i­ty re­view for mAb; Preprint sug­gests mix­ing boost­ers is safe ahead of ad­comms

Near­ly a year af­ter be­ing grant­ed an EUA, Re­gen­eron and Roche’s Covid-19 an­ti­body cock­tail will now go be­fore the FDA for a chance at full ap­proval.

The big biotech an­nounced Thurs­day it has sub­mit­ted a BLA for the drug, shoot­ing for an OK to treat Covid-19 in non-hos­pi­tal­ized pa­tients and as pro­phy­lax­is in cer­tain in­di­vid­u­als. Reg­u­la­tors grant­ed pri­or­i­ty re­view, set­ting April 13, 2022 as the PDU­FA date, and Re­gen­eron said the agency is prepar­ing an ad­comm be­fore then.

Re­gen­eron’s cock­tail, con­tain­ing the com­pounds casiriv­imab and imde­vimab, is al­ready au­tho­rized to treat mild to mod­er­ate Covid-19 pa­tients with high-risk co­mor­bidi­ties and in cer­tain pro­phy­lax­is set­tings.

Re­searchers are cen­ter­ing their pitch around two Phase III stud­ies look­ing at Covid-19 pa­tients who haven’t been hos­pi­tal­ized and asymp­to­matic house­hold con­tacts of Covid-pos­i­tive in­di­vid­u­als. Re­gen­eron is ex­pect­ed to fol­low up lat­er this year with an­oth­er BLA for hos­pi­tal­ized Covid-19 pa­tients.

Last month, Re­gen­eron and Roche se­cured a new con­tract with the US gov­ern­ment for the cock­tail to­tal­ing near­ly $3 bil­lion af­ter the Delta vari­ant caused a new Covid-19 wave across the coun­try. Up­take of the cock­tail had been slow up be­fore the surge, but sky­rock­et­ed over the sum­mer with fresh cas­es.

Preprint sug­gests mix­ing and match­ing boost­ers is safe

A new preprint of an NIH study has emerged de­tail­ing some pos­si­ble ef­fects of mix­ing and match­ing Covid-19 shots, as the FDA pre­pares for back-to-back vac­cine ad­comms for Mod­er­na and J&J boost­ers.

The preprint de­tails a tri­al of about 450 in­di­vid­u­als who were 12 weeks out from re­ceiv­ing both of their mR­NA vac­cine dos­es or the J&J shot, en­rolling rough­ly 150 from each of the vac­cine groups. Across the nine pos­si­ble com­bi­na­tions of sec­ond shots, an­ti­bod­ies in­creased be­tween four­fold and 76-fold and neu­tral­iz­ing an­ti­body titers went up be­tween four­fold and 56-fold.

No­tably, the high­est in­creas­es were de­tect­ed when those who had ini­tial­ly re­ceived a J&J shot got a boost­er of ei­ther the Mod­er­na or Pfiz­er-BioN­Tech vac­cine. The mean in­crease in an­ti­bod­ies for these re­spec­tive groups were 56-fold and 33-fold two weeks af­ter the sec­ond dose, re­spec­tive­ly.

In­di­vid­u­als who re­ceived two J&J shots on­ly saw a mean an­ti­body in­crease of about four­fold, mean­while. Re­searchers saw no new vac­cine-re­lat­ed ad­verse safe­ty events out­side what had been re­port­ed pre­vi­ous­ly: in­jec­tion site sore­ness, headaches and fa­tigue, among oth­ers.

But re­searchers stressed that the main find­ing is that boost­ers can po­ten­tial­ly be used re­gard­less of one’s pri­ma­ry vac­cine reg­i­men. There were sev­er­al lim­i­ta­tions to the study, chiefly that re­searchers did not track the num­ber of Covid-19 in­fec­tions.

The preprint fur­ther not­ed the study is not de­signed to di­rect­ly com­pare re­spons­es be­tween boost­er reg­i­mens, the study is too small to make any sweep­ing con­clu­sions and the tri­al pop­u­la­tion is not rep­re­sen­ta­tive of the US writ large. The dif­fer­ent pop­u­la­tions al­so were not ran­dom­ized and the fol­low-up pe­ri­ods of two and four weeks were much short­er than the time sought for boost­ers by Pfiz­er and Mod­er­na.

Pfiz­er’s boost­er re­ceived au­tho­riza­tion in some pop­u­la­tions six months af­ter the ini­tial two-dose reg­i­men, while Mod­er­na is seek­ing a sim­i­lar time­frame. The Mod­er­na shot used in this study is al­so dou­ble the dose of what the biotech is seek­ing for a boost­er EUA.

It re­mains to be seen how the preprint will shape the de­bates at the boost­er ad­comms — Thurs­day for Mod­er­na and Fri­day for J&J. In their re­view for Mod­er­na boost­ers, reg­u­la­tors of­fered the same luke­warm take as giv­en to the Pfiz­er-BioN­Tech pitch, not­ing the da­ta to be less than gob­s­mack­ing­ly per­sua­sive.

But the agency au­tho­rized Pfiz­er-BioN­Tech boost­ers nonethe­less af­ter a chaot­ic ad­comm, say­ing old­er in­di­vid­u­als and adults with un­der­ly­ing health con­di­tions could re­ceive a third shot. The agency al­so of­fered the op­tion for work­ers in high-risk sit­u­a­tions to get a boost­er.

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

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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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Aaron Siri, Siri & Glimstad

FDA shuts down an­ti-vax lawyer's pe­ti­tion to end Mod­er­na and J&J EUAs

Despite the efforts of a law firm leading the charge on the anti-vaccination movement, the emergency use authorization for Moderna and J&J’s Covid-19 vaccines will not be revoked, the agency said in a response letter Monday.

The FDA said so in a letter to an anti-vax lawyer based in New York City. Aaron Siri, from Siri & Glimstad, requested in a formal petition that the EUAs granted to Moderna and J&J be revoked after weeks of back-and-forth email correspondence with Peter Marks, Lorrie McNeill and others at the FDA.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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