Covid-19 roundup: Re­gen­eron asks FDA: Which gov­ern­ment agen­cies are track­ing vari­ants of con­cern?; Pfiz­er, As­traZeneca vac­cines most­ly hold strong against Delta vari­ant

As the race to keep Covid-19 vari­ants at bay con­tin­ues, Re­gen­eron is call­ing on the FDA to pro­vide ad­di­tion­al clar­i­ty on which gov­ern­ment agen­cies are ac­tu­al­ly track­ing and pub­lish­ing lists on vari­ants of con­cern like the Delta vari­ant.

The New York-based biotech, which has made a name for it­self dur­ing the pan­dem­ic for not on­ly treat­ing for­mer Pres­i­dent Trump with its an­ti­body cock­tail but al­so de­vel­op­ing a cock­tail that can with­stand the chang­ing na­ture of the coro­n­avirus in the US. Mean­while, its com­peti­tors from Eli Lil­ly were pulled from the mar­ket late last month as vari­ants were able to pen­e­trate the firm’s an­ti­body drugs.

Lil­ly clar­i­fied that its com­bo of bam­lanivimab and ete­se­vimab ad­min­is­tered to­geth­er does not re­tain neu­tral­iza­tion ef­fects against the Gam­ma or Be­ta vari­ants, has slight­ly re­duced ac­tiv­i­ty against the Ep­silon, Io­ta and Kap­pa vari­ants, but does re­tain neu­tral­iza­tion ac­tiv­i­ty against the Delta and Al­pha vari­ants.

“Spon­sors de­vel­op­ing mon­o­clon­al an­ti­bod­ies tar­get­ing emerg­ing SARS-CoV-2 vari­ants would ben­e­fit from know­ing which Agen­cies are track­ing and pub­lish­ing lists with the vari­ants of con­cerns that should be tar­get­ed, sim­i­lar­ly to what is done with in­fluen­za virus strains,” Re­gen­eron said in a com­ment post­ed re­cent­ly by the FDA.

A Re­gen­eron spokesper­son not­ed to End­points News that the com­pa­ny of­fers a pub­licly-avail­able track­ing dash­board on vari­ants, in­clud­ing through this dash­board we’ve made pub­licly avail­able and that is re­freshed dai­ly with new genomes/meta­da­ta from GI­SAID, which is a glob­al ini­tia­tive and pri­ma­ry source that pro­vides open-ac­cess to ge­nom­ic da­ta of in­fluen­za virus­es and the coro­n­avirus.

The biotech al­so sug­gest­ed that FDA could strength­en its rec­om­men­da­tions from its Feb­ru­ary guid­ance, and help en­sure that spon­sors are best po­si­tioned to de­vel­op mon­o­clon­al an­ti­bod­ies to the SARS-CoV-2 vari­ants pos­ing the great­est threats to pub­lic health.

Re­gen­eron al­so sug­gest­ed that the CDC and/or the WHO guid­ance doc­u­ments on vari­ants are ref­er­enced in FDA’s guid­ance. — Zachary Bren­nan

New study shows Pfiz­er/BioN­Tech, As­traZeneca vac­cines hold up against Delta vari­ant

A new study found “on­ly mod­est dif­fer­ences” in pro­tec­tion of­fered by the Pfiz­er/BioN­Tech and As­traZeneca Covid-19 vac­cines against the Delta vari­ant, which has be­come the dom­i­nant strain in the US.

On Tues­day, CDC di­rec­tor Rochelle Walen­sky said the Delta vari­ant, which was first iden­ti­fied in In­dia, now ac­counts for about 83% of all Covid-19 cas­es in the US, up from just over 50% a few days pri­or. This par­tic­u­lar strain is thought to have in­creased repli­ca­tion, which leads to high­er vi­ral loads and in­creased trans­mis­sion.

Ear­li­er this month, re­searchers at the Guang­dong Provin­cial Cen­ter for Dis­ease Con­trol and Pre­ven­tion re­port­ed that on av­er­age, peo­ple in­fect­ed with the new strain had 1,000 times more copies of the virus in their res­pi­ra­to­ry tracts than those in­fect­ed with the orig­i­nal strain.

Ac­cord­ing to a study fund­ed by Pub­lic Health Eng­land and pub­lished in the New Eng­land Jour­nal of Med­i­cine, two dos­es of Pfiz­er’s vac­cine were found to be 88% ef­fec­tive against the Delta vari­ant, com­pared to 93.7% ef­fec­tive against the Al­pha strain. And As­traZeneca’s shot was 67% ef­fec­tive against the Delta vari­ant, ver­sus 74.5% ef­fec­tive against the Al­pha.

The pro­tec­tion of­fered by just one shot of ei­ther vac­cine was “no­tably low­er,” the re­searchers said, with both vac­cines show­ing ef­fi­ca­cy rates around 30.7% for the Delta vari­ant and 48.7% for the Al­pha vari­ant.

“On­ly mod­est dif­fer­ences in vac­cine ef­fec­tive­ness were not­ed with the delta vari­ant as com­pared with the al­pha vari­ant af­ter the re­ceipt of two vac­cine dos­es,” the re­searchers wrote.

A dif­fer­ent study pub­lished on Mon­day (which has not been peer-re­viewed) showed that neu­tral­iz­ing titers in­duced by J&J’s vac­cine de­creased 5.4-fold against the “Delta plus” vari­ant, a mu­ta­tion that sci­en­tists say al­lows the virus to bet­ter at­tack the lungs. — Nicole De­Feud­is

Top Chi­nese of­fi­cial speaks out against WHO’s Covid-19 ori­gin study — re­port 

Amid brew­ing con­tro­ver­sy over the ori­gins of Covid-19, Chi­na’s Na­tion­al Health Com­mis­sion Vice Min­is­ter Zeng Yix­in said he was “rather tak­en aback” by the World Health Or­ga­ni­za­tion’s plans for the sec­ond phase of a study to rule out whether the virus leaked from a lab, ac­cord­ing to the As­so­ci­at­ed Press. 

Zeng re­port­ed­ly dis­missed the lab-leak the­o­ry as a ru­mor lack­ing in com­mon sense.

“It is im­pos­si­ble for us to ac­cept such an ori­gin-trac­ing plan,” he told re­porters, per the AP.

The WHO said back in Feb­ru­ary that the pos­si­bil­i­ty of the nov­el coro­n­avirus stem­ming from the re­sult of a lab ac­ci­dent was “ex­treme­ly un­like­ly,” adding that ev­i­dence con­tin­ues to point to the virus jump­ing from an­i­mals to hu­mans.

How­ev­er, the lab ac­ci­dent the­o­ry, which was at times pro­mot­ed by for­mer Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion, has gained trac­tion in the US, with the con­tro­ver­sy erupt­ing back in May when Pres­i­dent Joe Biden or­dered the US com­mu­ni­ty and gov­ern­ment labs to dou­ble down on their ef­forts to reach a con­sen­sus.

“Cer­tain­ly, the peo­ple who in­ves­ti­gat­ed it say it like­ly was the emer­gence from an an­i­mal reser­voir that then in­fect­ed in­di­vid­u­als, but it could have been some­thing else, and we need to find that out. So, you know, that’s the rea­son why I said I’m per­fect­ly in fa­vor of any in­ves­ti­ga­tion that looks in­to the ori­gin of the virus,” NI­AID di­rec­tor An­tho­ny Fau­ci said at a Sen­ate Ap­pro­pri­a­tions Com­mit­tee hear­ing in May.

Chi­nese of­fi­cials have re­peat­ed­ly de­nied that the Wuhan In­sti­tute of Vi­rol­o­gy in Chi­na had any­thing to do with the out­break, and Zeng said the Wuhan lab has no virus that can di­rect­ly in­fect hu­mans, ac­cord­ing to the AP. — Nicole De­Feud­is

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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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