Covid-19 roundup: CDC ad­vi­sors find like­ly link be­tween mR­NA vac­cines and rare cas­es of heart in­flam­ma­tion; NIH launch­es new vac­cine study in preg­nant vol­un­teers 

The FDA will up­date the fact sheets for the Pfiz­er/BioN­Tech and Mod­er­na Covid-19 vac­cines, af­ter the CDC ad­vi­so­ry group ACIP found that rare cas­es of heart in­flam­ma­tion in ado­les­cents and young adults are like­ly linked to the shots, Reuters re­port­ed.

Ac­cord­ing to the CDC’s web­site, there have been more than a thou­sand re­ports of heart in­flam­ma­tion fol­low­ing mR­NA vac­ci­na­tion since April. These cas­es are rare, ac­cord­ing to the agency, giv­en the hun­dreds of mil­lions of dos­es ad­min­is­tered. Most have been mild, and in­di­vid­u­als of­ten re­cov­er on their own or with min­i­mal treat­ment, sev­er­al pub­lic health fig­ures said in a joint state­ment.

“In ad­di­tion, we know that my­ocardi­tis and peri­cardi­tis are much more com­mon if you get COVID-19, and the risks to the heart from COVID-19 in­fec­tion can be more se­vere,” they said in the state­ment. “We strong­ly en­cour­age every­one age 12 and old­er who are el­i­gi­ble to re­ceive the vac­cine un­der Emer­gency Use Au­tho­riza­tion to get vac­ci­nat­ed, as the ben­e­fits of vac­ci­na­tion far out­weigh any harm.”

Tom Shimabukuro

Tom Shimabukuro, deputy di­rec­tor of the CDC’s Im­mu­niza­tion Safe­ty Of­fice, said that da­ta from one safe­ty mon­i­tor­ing sys­tem sug­gests 12.6 cas­es of heart in­flam­ma­tion per mil­lion 12- to 39-year-olds in the three weeks fol­low­ing the sec­ond shot, per Reuters.

“We’re ob­serv­ing this in the younger age groups, main­ly in peo­ple in the teens and ear­ly 20s, and ob­serv­ing it more in males, com­pared to fe­males,” he said, ac­cord­ing to Reuters. “This ef­fect large­ly kind of dis­ap­pears once you get in­to these old­er age groups – in­di­vid­u­als 50 and over.”

The CDC has ad­vised those get­ting the shots to be on the look­out for chest pain, short­ness of breath, and a fast-beat­ing, flut­ter­ing or pound­ing heart.

Mod­er­na’s stock $MR­NA was down 4.21% up­on yes­ter­day’s close, and Pfiz­er’s $PFE was down 1.41%.

NIH launch­es new vac­cine study in preg­nant vol­un­teers 

Al­though tens of thou­sands of preg­nant or breast­feed­ing peo­ple in the US have al­ready re­ceived a Covid-19 shot, the NIH is launch­ing a new study to eval­u­ate the shots in this group, ac­cord­ing to NI­AID di­rec­tor An­tho­ny Fau­ci.

The study, dubbed MO­MI-VAX, will en­roll up to 750 preg­nant par­tic­i­pants and 250 who have giv­en birth in the last two months who have re­ceived or will re­ceive any Covid-19 vac­cine au­tho­rized in the US. Cur­rent­ly, that in­cludes the Pfiz­er/BioN­Tech, Mod­er­na and J&J jabs.

Re­searchers will then mea­sure vac­cine safe­ty, the de­vel­op­ment and dura­bil­i­ty of an­ti­bod­ies against SARS-CoV-2, and the trans­fer of vac­cine-in­duced an­ti­bod­ies to in­fants across the pla­cen­ta and through breast milk.

“The re­sults of this study will fill gaps in our knowl­edge and help in­form pol­i­cy rec­om­men­da­tions and per­son­al de­ci­sion-mak­ing on COVID-19 vac­ci­na­tion dur­ing preg­nan­cy and in the post­par­tum pe­ri­od,” Fau­ci said in a state­ment.

The par­tic­i­pants and their ba­bies will be mon­i­tored for one year. So far, the vac­cines ap­pear safe in preg­nant and post­par­tum pop­u­la­tions, the NIH said.

Preg­nant peo­ple with Covid-19 are more like­ly to be hos­pi­tal­ized and ad­mit­ted to the ICU, ac­cord­ing to the NIH. They are al­so more like­ly to re­quire ven­ti­la­tion, and die from the ill­ness. And se­vere Covid-19 dur­ing preg­nan­cy may put the in­fant at risk for com­pli­ca­tions like preterm birth, the agency said.

Pfiz­er and BioN­Tech are con­duct­ing their own Phase II/III study in preg­nant peo­ple, and dosed the first of 4,000 par­tic­i­pants in Feb­ru­ary. That tri­al will vac­ci­nate vol­un­teers dur­ing 24 to 34 weeks of ges­ta­tion, with two dos­es of the vac­cine or place­bo giv­en 21 days apart.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, Congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

UP­DAT­ED: Sanofi buys mR­NA play­er Trans­late Bio for $3.2B. And the price fits a pop­u­lar range for biotech M&A

Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio $TBIO a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines, Sanofi closed the deal with a buyout early Tuesday, spending $38 a share in a $3.2 billion buyout.

Translate’s stock $TBIO soared after the market closed Monday when Reuters reported the first word of the acquisition just hours ahead of the formal announcement. The wire service, though, didn’t have a price to report in its scoop, and investors chased the stock up 78% in the wild ride that followed. Once the price was announced, gains shriveled to 29% ahead of the bell.

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