Anthony Fauci (Greg Nash/Pool via AP Images)

Fau­ci calls for de­vel­op­ment of pan-coro­n­avirus and in­tranasal vac­cines in fight against Covid vari­ants

Even as vac­cine man­u­fac­tur­ers plow a path to mar­ket for Omi­cron-spe­cif­ic boost­er shots this fall, NI­AID di­rec­tor An­tho­ny Fau­ci’s mes­sage is clear: “Our job is not done.”

Fau­ci, who al­so serves as chief med­ical ad­vi­sor to Pres­i­dent Joe Biden, took the White House podi­um on Tues­day to of­fer a glimpse at where next-gen­er­a­tion vac­cines are head­ed — specif­i­cal­ly high­light­ing the need for pan-coro­n­avirus can­di­dates and mu­cos­al op­tions that can be ad­min­is­tered in­tranasal­ly.

“In­no­v­a­tive ap­proach­es are clear­ly need­ed to in­duce broad and durable pro­tec­tion against coro­n­avirus­es known and un­known,” he said.

At the end of last month, the FDA rec­om­mend­ed that vac­cine man­u­fac­tur­ers like Pfiz­er and Mod­er­na move for­ward with Omi­cron-spe­cif­ic for­mu­la­tions, which may be avail­able in ear­ly- to mid-fall.

Thanks to cur­rent vac­cines, we’ve avert­ed well over two mil­lion deaths and about a tril­lion dol­lars in health­care costs, Fau­ci said. How­ev­er, vac­cine de­vel­op­ment is be­com­ing in­creas­ing­ly com­pli­cat­ed, as we’re now see­ing “sub­lin­eages of sub­lin­eages” of Covid vari­ants.

“These in­jectable vac­cines do a great job at pre­vent­ing se­vere dis­ease, but they do lit­tle to pre­vent in­fec­tion and trans­mis­sion, and trans­mis­sion is the en­gine of vari­ant evo­lu­tion,” said Mar­tin Moore, CSO and co­founder of Meis­sa Vac­cines.

Down the road, Fau­ci ad­vo­cat­ed for pan-coro­n­avirus vac­cines, or mu­cos­al op­tions that could po­ten­tial­ly stop trans­mis­sion in its tracks.

“When you have a mu­cos­al, and in this case, in­tranasal, what you do is you stim­u­late at the lo­cal lev­el,” Fau­ci said dur­ing the sum­mit, which was broad­cast live on Zoom. “The goal of that is not on­ly to pro­tect against dis­ease, but to pro­tect against ac­qui­si­tion and by ac­qui­si­tion, trans­mis­sion. And that’s re­al­ly the holy grail.”

Akiko Iwasa­ki

Cur­rent vac­cines in­duce ro­bust sys­temic im­mune re­spons­es, but do not in­duce a mu­cos­al re­sponse, ac­cord­ing to Akiko Iwasa­ki, an im­munol­o­gy pro­fes­sor at Yale Uni­ver­si­ty. She’s al­so the co-founder of Xanadu Bio, a Yale spin­out look­ing to bring an in­tranasal Covid can­di­date in­to the clin­ic. Mu­cos­al vac­cines are de­signed to pre­vent a virus from ever get­ting to a host cell, like putting a guard out­side your house to pro­tect from in­vaders, Iwasa­ki said.

Iwasa­ki re­cent­ly co-au­thored a pa­per in Sci­ence Im­munol­o­gy along­side Scripps Re­search Trans­la­tion­al In­sti­tute founder Er­ic Topol that ad­vo­cates for an ac­cel­er­at­ed ini­tia­tive for in­tranasal Covid-19 vac­cines, sim­i­lar to Op­er­a­tion Warp Speed.

“We know from 200 years of vac­ci­nol­o­gy … that vac­cines that mim­ic nat­ur­al in­fec­tion tend to work best,” Moore said. “No one here to­day can tell you that mu­cos­al COVID vac­cines work, we’re not there yet. We need clin­i­cal ef­fi­ca­cy da­ta to an­swer that ques­tion, and that’s why we’re here.”

Paul Bur­ton

Man­u­fac­tur­ing is al­so “a key part of the fu­ture,” Mod­er­na’s CMO Paul Bur­ton said at the sum­mit, adding that the com­pa­ny has re­cent­ly struck deals to build new plants and R&D sites in Aus­tralia, the Unit­ed King­dom, Cana­da and Kenya.

“We have to con­tin­ue these dis­cus­sions, con­tin­ue these col­lab­o­ra­tions to in­still con­fi­dence,” Bur­ton said. “Get­ting that con­fi­dence and then the abil­i­ty to get these shots made in coun­tries and in­to peo­ple’s arms I think is how we’re go­ing to con­tin­ue to get out of the pan­dem­ic.”

Pfiz­er bio­phar­ma group pres­i­dent An­gela Hwang added that the de­vel­op­ers con­tin­ue to im­ple­ment lessons learned from the pan­dem­ic to make the process more ef­fi­cient.

“Prob­a­bly two and a half bil­lion peo­ple have re­ceived the Pfiz­er vac­cine,” she said. “That’s an in­cred­i­ble wealth of re­al world ev­i­dence that we’re sit­ting on. And so I think that we have a great op­por­tu­ni­ty, hav­ing that strong depth and breadth of da­ta, to use that to al­so help us to un­der­stand, how can we de­sign new ther­a­pies?”

*A cor­rec­tion has been made to the at­tri­bu­tion of two quotes by Mar­tin Moore.

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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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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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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(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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