Dawn O'Connell (Michael Brochstein/Sipa USA/Sipa via AP Images)

Covid-19 roundup: Mod­er­na, US sign con­tract for au­tumn boost­er dos­es; Enan­ta touts PhI re­sults for its an­tivi­ral

The US gov­ern­ment has placed a con­tract for 66 mil­lion dos­es of Mod­er­na’s Covid-19 vac­cine boost­er can­di­date, and the deal could bal­loon to an­oth­er 234 mil­lion dos­es.

The con­tract in­cludes up to $1.74 bil­lion for Mod­er­na to man­u­fac­ture and de­liv­er the dos­es of the bi­va­lent vac­cine can­di­date, dubbed mR­NA-1273.222. The shot con­tains anti­gens against the BA.4/BA.5 Omi­cron sub­vari­ant strains and is part of Mod­er­na’s ef­fort to de­liv­er a boost­er shot this au­tumn, pend­ing the nec­es­sary go-ahead from the FDA and CDC.

Per shot, that’s $26.36. In Au­gust 2020, the US bought 100 mil­lion dos­es of the Mod­er­na vac­cine for about $10 less, at ap­prox­i­mate­ly $15.75 a pop, ac­cord­ing to Reuters. Mean­while, the Eu­ro­pean Union has in the past paid be­tween $22.60 to $25.50 for each Mod­er­na dose, ac­cord­ing to the New York Times.

“We look for­ward to re­ceiv­ing these new vari­ant-spe­cif­ic vac­cines and work­ing with state and lo­cal health­care part­ners to make the vac­cines avail­able for free in com­mu­ni­ties around the coun­try this fall,” Health and Hu­man Ser­vices As­sis­tant Sec­re­tary Dawn O’Con­nell said in a state­ment.

Enan­ta Phar­ma­ceu­ti­cals touts pos­i­tive PhI da­ta for its oral Covid-19 treat­ment

A Mass­a­chu­setts biotech that main­ly works on de­vel­op­ing small mol­e­cule drugs for vi­ral in­fec­tions and liv­er dis­eases is al­so de­vel­op­ing an oral an­tivi­ral for Covid-19 — and is now pro­vid­ing da­ta.

Jay Lu­ly

Enan­ta Phar­ma­ceu­ti­cals an­nounced topline da­ta on Fri­day from its Phase I study as­sess­ing the safe­ty and tol­er­a­bil­i­ty of a once-dai­ly oral can­di­date, dubbed EDP-235, in healthy adults. The can­di­date is a 3CL pro­tease in­hibitor.

Ac­cord­ing to the da­ta from Enan­ta’s Phase I, the re­sults showed the can­di­date had fa­vor­able safe­ty, tol­er­a­bil­i­ty, and PK with strong ex­po­sure mul­ti­ples over the EC90, which sup­ports mov­ing for­ward in a Phase II study in the fourth quar­ter of the year us­ing on­ly one dose.

The com­pa­ny said the can­di­date is safe and well-tol­er­at­ed in healthy sub­jects for up to 400 mg for up to sev­en days. The ad­verse events in­clud­ed headache and gas­troin­testi­nal-re­lat­ed symp­toms dur­ing the in­ves­ti­ga­tion with mul­ti­ple dos­es.

There were three study dis­con­tin­u­a­tions re­port­ed with one mod­er­ate headache in the 400 mg co­hort, one se­vere headache with 800 mg and one grade 3 ALT/grade 2 AST el­e­va­tion al­so in the 800 mg sec­tion. A to­tal of 72 sub­jects were a part of the study.

“Pre­clin­i­cal da­ta show good dis­tri­b­u­tion in­to oth­er key tar­get tis­sues, which may al­low EDP-235 to in­hib­it the virus at pos­si­ble sites of on­go­ing repli­ca­tion po­ten­tial­ly linked to long Covid. Our da­ta sup­port a con­ve­nient dos­ing reg­i­men, with strong ex­po­sure mul­ti­ples for both the 200mg and 400mg dos­es, with­out the need for ri­ton­avir boost­ing. We are tar­get­ing a one pill, a once-a-day an­tivi­ral treat­ment reg­i­men that is ac­tive against all COVID-19 vari­ants of con­cern,” said Enan­ta CEO Jay Lu­ly.

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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