Stéphane Bancel, Moderna CEO (Charles Krupa/AP Images)

Mod­er­na beats Pfiz­er to the punch, files EUA for Covid-19 vac­cine for youngest chil­dren

Covid-19 vac­cines for the youngest group of chil­dren (un­der the age of six) may soon be avail­able ⁠— po­ten­tial­ly in the next month ⁠— as Mod­er­na an­nounced on Thurs­day morn­ing that it has sub­mit­ted an EUA re­quest to the FDA.

The FDA still needs to re­view the ap­pli­ca­tion, which is based on da­ta un­veiled late last month show­ing a ro­bust neu­tral­iz­ing an­ti­body re­sponse in the 6 month to un­der 6 years age group af­ter a two-dose se­ries of the vac­cine, along with a fa­vor­able safe­ty pro­file. The FDA still needs to set up an ad­vi­so­ry com­mit­tee of out­side ex­perts to re­view the da­ta.

Pe­ter Marks

How long that re­view may take is still up in the air. But the FDA’s vac­cine chief Pe­ter Marks told a Sen­ate com­mit­tee on Tues­day that a vac­cine for this youngest age group is a top pri­or­i­ty, and a sched­ule is com­ing with­in a week.

The FDA pre­vi­ous­ly sched­uled and then post­poned an ad­comm meet­ing to re­view Pfiz­er/BioN­Tech vac­cine da­ta on two dos­es for this same youngest age group, but the com­pa­nies de­cid­ed to pull back at the last minute with­out be­ing en­tire­ly clear, as an ap­pli­ca­tion was not sub­mit­ted and new da­ta were not made pub­lic.

More re­cent­ly, Pfiz­er said it’s go­ing for a third dose and ex­pects to re­lease da­ta on its vac­cine in this group of in­fants and chil­dren be­fore the end of the quar­ter, al­though the New York Times re­port­ed re­cent­ly that ap­pli­ca­tion could come as soon as next month.

As far as the time­line for when these Mod­er­na vac­cines may be avail­able, Marks al­so told a Sen­ate com­mit­tee on Tues­day that the FDA will be re­leas­ing plans for hold­ing the ad­comm meet­ing, and pro­vid­ing a time­line on its re­view with­in the next week.

The tim­ing re­mains a big ques­tion mark and is de­pen­dent on how quick­ly the FDA can re­view the ap­pli­ca­tion, which typ­i­cal­ly (out­side a pan­dem­ic) would take the agency six to 10 months to re­view, but will like­ly be con­densed to weeks in this case. The agency may al­so opt to hold a joint Pfiz­er-Mod­er­na VRB­PAC meet­ing to al­low its out­side ad­vi­sors to re­view all of the da­ta to­geth­er.

Paul Of­fit

Paul Of­fit, pro­fes­sor of pe­di­atrics at Chil­dren’s Hos­pi­tal of Philadel­phia and a mem­ber of the ad­comm that would meet to dis­cuss the Mod­er­na and Pfiz­er da­ta, told End­points News via email, “Noth­ing on the sched­ule un­til June.” But he al­so clar­i­fied that he didn’t know what would be dis­cussed in June. The Mod­er­na VRB­PAC meet­ing may not have been sched­uled yet.

If au­tho­rized, the Mod­er­na vac­cines will like­ly be made avail­able at no cost to Amer­i­cans as the tri­al on which the EUA is based was fund­ed by the US gov­ern­ment and con­duct­ed in col­lab­o­ra­tion with the NIH’s Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases and the Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty.

Mod­er­na CEO Stéphane Ban­cel said in a state­ment, “We be­lieve mR­NA-1273 will be able to safe­ly pro­tect these chil­dren against SARS-CoV-2, which is so im­por­tant in our con­tin­ued fight against COVID-19, and will be es­pe­cial­ly wel­comed by par­ents and care­givers.”

Sim­i­lar to Pfiz­er, Mod­er­na said it’s al­so cur­rent­ly study­ing boost­er dos­es for the two old­est pe­di­atric co­horts, and the com­pa­ny is de­sign­ing a study to eval­u­ate the po­ten­tial for a boost­er for those aged 6 months to un­der 6 years too.

The com­pa­ny said it is eval­u­at­ing boost­er dos­es of the orig­i­nal vac­cine, as well as a bi­va­lent boost­er can­di­date, known as mR­NA-1273.214, which in­cludes both Omi­cron-spe­cif­ic mR­NA and mR­NA-1273. Mod­er­na al­so re­cent­ly un­veiled promis­ing da­ta for an­oth­er bi­va­lent boost­er, known as mR­NA-1273.211 and which in­cludes mu­ta­tions found in the Be­ta vari­ant of con­cern, and which best­ed the com­pa­ny’s orig­i­nal boost­er in terms of neu­tral­iz­ing titers against all vari­ants of con­cern, in­clud­ing Omi­cron.

The news, which fol­lows sim­i­lar re­sults for the Pfiz­er/BioN­Tech Covid-19 vac­cine when com­bined with Be­ta, bodes well for the boost­er sea­son com­ing in the fall.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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