Covid-19 roundup: EMA rec­om­mends an ad­di­tion­al boost­er dose; Mod­er­na touts shot tar­get­ing Omi­cron sub­vari­ants

As sev­er­al ver­sions of Covid-19’s Omi­cron vari­ant con­tin­ue to rage across the US and Eu­rope, the EMA and the ED­CD are mak­ing some new rec­om­men­da­tions.

The EMA now rec­om­mends that a sec­ond boost­er dose of mR­NA Covid-19 vac­cines should be con­sid­ered for peo­ple be­tween 60 and 79 years old and for peo­ple with high-risk med­ical con­di­tions.

In April, both or­ga­ni­za­tions ini­tial­ly rec­om­mend­ed that on­ly peo­ple over 80 years of age should be con­sid­ered for a sec­ond boost­er. How­ev­er, the agen­cies not­ed at the time that it might be nec­es­sary to con­sid­er sec­ond boost­ers for peo­ple be­tween 60 and 79 years old and for vul­ner­a­ble per­sons of any age if there were any fur­ther resur­gences.

The agen­cies not­ed that the boost­er could be ad­min­is­tered at least four months af­ter the pre­vi­ous one, with a fo­cus on peo­ple who have re­ceived a pre­vi­ous boost­er more than six months ago.

An­drea Am­mon

“We are cur­rent­ly see­ing in­creas­ing Covid-19 case no­ti­fi­ca­tion rates and an in­creas­ing trend in hos­pi­tal and ICU ad­mis­sions and oc­cu­pan­cy in sev­er­al coun­tries main­ly dri­ven by the BA.5 sub­lin­eage of Omi­cron. This sig­nals the start of a new, wide­spread Covid-19 wave across the Eu­ro­pean Union. There are still too many in­di­vid­u­als at risk of se­vere COVID-19 in­fec­tion whom we need to pro­tect as soon as pos­si­ble,” said ECDC di­rec­tor An­drea Am­mon.

For the wider pop­u­la­tion, how­ev­er, the EMA has pre­sent­ed no clear ev­i­dence to sup­port giv­ing a sec­ond boost­er dose to peo­ple be­low 60 years of age who are not at high­er risk of se­vere dis­ease. There is al­so no clear ev­i­dence from the EMA to sup­port giv­ing ear­ly sec­ond boost­ers to health­care work­ers or those work­ing in long-term care homes un­less they are at high risk. But res­i­dents at long-term care homes are like­ly to be at risk of se­vere dis­ease and should be con­sid­ered for boost­er dos­es.

Even though adapt­ed vac­cines for the Omi­cron vari­ant are in de­vel­op­ment, Eu­ro­pean reg­u­la­tors are stick­ing to the cur­rent vac­cines for now. — Tyler Patchen

Mod­er­na touts da­ta for boost­er tar­get­ing BA.4 and BA.5

Mod­er­na is tout­ing new boost­er da­ta Mon­day for a po­ten­tial shot tar­get­ing the pre­dom­i­nant Omi­cron sub­vari­ants.

Stéphane Ban­cel

In a press re­lease Mon­day, the pan­dem­ic dar­ling said the Omi­cron-at­tuned shot re­sult­ed in “sig­nif­i­cant­ly high­er neu­tral­iz­ing titers against BA.4/5” com­pared to the cur­rent­ly au­tho­rized boost­er, which tar­gets the orig­i­nal virus strain. The da­ta come from a bi­va­lent shot tar­get­ing mul­ti­ple strains called mR­NA-1273.214.

“We are very pleased that our bi­va­lent plat­form con­tin­ues to demon­strate bet­ter per­for­mance than the cur­rent boost­er,” CEO Stéphane Ban­cel said in a state­ment. “To­day’s up­date ex­tends the re­mark­able per­for­mance of mR­NA-1273.214, demon­strat­ing sig­nif­i­cant­ly high­er titers against all test­ed vari­ants, in­clud­ing the BA.4/5 and BA.1 Omi­cron sub­vari­ants.”

Mod­er­na is test­ing mul­ti­ple po­ten­tial shots for a fall boost­er roll­out and said Mon­day that mR­NA-1273.214 is the on­ly can­di­date ex­pect­ed to have high­er titers against the BA.4 and BA.5 strains to be test­ed in clin­i­cal tri­als in time for a launch. An­oth­er can­di­date, mR­NA-1273.222, is still un­der de­vel­op­ment. — Max Gel­man

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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An­oth­er one bites the dust? FDA warns that emerg­ing Omi­cron sub­vari­ant could make Evusheld ob­so­lete

AstraZeneca’s Covid-19 pre-exposure prophylactic Evusheld has managed to remain relevant for immunocompromised and other patients when many of its therapeutic peers haven’t with each new Omicron subvariant.

But that win streak may slowly come to a close as the FDA told healthcare providers on Monday that one of the emerging subvariants, BA.4.6, renders Evusheld almost completely useless.

Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Stéphane Bancel, CEO of Moderna

Mod­er­na re­fused to dis­close mR­NA vac­cine tech­nol­o­gy to Chi­na — re­port

Moderna has been protective of the intellectual property surrounding its vaccine, including being willing to go to court and accusing other companies of patent infringement. Now the most recent update puts a magnifying glass on Moderna’s dealings with China.

Per a report from the Financial Times over the weekend, China asked Moderna to hand over the intellectual property behind its megablockbuster vaccine known as Spikevax. Citing people “familiar with the matter,” the report notes that the mRNA biotech was in negotiations with China in 2020 and 2021 to sell its product in the world’s most populous country.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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