Jean-Pierre Sommadossi, Atea CEO

Covid-19 roundup: Atea Phar­ma­ceu­ti­cals launch­es an­tivi­ral in­to PhI­II tri­al; Cell­tri­on's an­ti­body shows promise against vari­ant

About a year af­ter jump­ing in­to the Covid-19 fight with its lead an­tivi­ral, Atea Phar­ma­ceu­ti­cals has launched a Phase III tri­al in mild to mod­er­ate pa­tients who are not hos­pi­tal­ized.

The drug (and com­pa­ny) come from Jean-Pierre Som­ma­dos­si, the founder of Idenix and a co-founder of Phar­mas­set. The com­pa­ny de­cid­ed to di­vert all their at­ten­tion to Covid-19 last Feb­ru­ary, then pulled in $215 mil­lion to launch a cross-coun­try Phase II tri­al in May.

“Hope­ful­ly we will not have a sec­ond wave,” Som­ma­dos­si told End­points News at the time. “But if we have a sec­ond wave, we need to be ready this time.”

In Oc­to­ber, Roche put down $350 mil­lion up­front plus undis­closed mile­stones and roy­al­ties for ex-US rights to the can­di­date, dubbed AT-527, as an oral an­tivi­ral treat­ment for Covid-19. The ther­a­py works by block­ing the vi­ral RNA poly­merase en­zyme need­ed for vi­ral repli­ca­tion, ac­cord­ing to Roche.

The Phase III MORN­INGSKY tri­al will en­roll 1,400 non-hos­pi­tal­ized pa­tients, in­clud­ing ado­les­cents, who are with­in five days of symp­tom on­set. The study’s pri­ma­ry end­point will eval­u­ate the time to im­prove­ment of symp­toms com­pared to a place­bo. Par­tic­i­pants will come from a va­ri­ety of clin­i­cal tri­al sites world­wide, in­clud­ing in Japan, ac­cord­ing to Atea.

In ad­di­tion to MORN­INGSKY, Roche and Atea are test­ing the can­di­date in a glob­al Phase II for hos­pi­tal­ized pa­tients with mod­er­ate Covid-19, and a Phase II vi­rol­o­gy study in out­pa­tients with mild to mod­er­ate sick­ness.

“As a di­rect-act­ing an­tivi­ral, AT-527 aims to pre­vent dis­ease pro­gres­sion by in­hibit­ing vi­ral repli­ca­tion and there­by re­duc­ing the sever­i­ty of dis­ease, pre­vent­ing or short­en­ing hos­pi­tal­iza­tion, and al­so po­ten­tial­ly pre­vent­ing trans­mis­sion of the virus to oth­ers,”  Som­ma­dos­si said in a state­ment. “This makes it well-suit­ed for po­ten­tial use in both pre- and post-ex­po­sure pro­phy­lac­tic set­tings and com­ple­men­tary to vac­cines.” — Nicole De­Feud­is 

Cell­tri­on’s mAb shows suc­cess against South African vari­ant

Pre-clin­i­cal tri­al re­sults from Cell­tri­on Group’s an­ti-Covid-19 mon­o­clon­al an­ti­body reg­dan­vimab showed neu­tral­iza­tion of the South African vari­ant, the com­pa­ny an­nounced Thurs­day.

Reg­dan­vimab proved ef­fec­tive in an in vi­vo mod­el by bind­ing against the re­cep­tor bind­ing do­main in three mu­ta­tions (K417N, E484K and N501Y) of the vari­ant, Cell­tri­on said in a re­lease. How­ev­er, it al­so showed re­duced sus­cep­ti­bil­i­ty against the South African vari­ant in a live virus and pseu­do-virus in vit­ro study though there was no sig­nif­i­cant dif­fer­ence be­tween the vari­ants and the wild type when ob­serv­ing vi­ral res­pi­ra­to­ry in­fec­tion.

In a state­ment, head of med­ical and mar­ket­ing Ho-Ung Kim said, “Faced with the rapid spread of COVID-19 vari­ants, glob­al ac­cess to ef­fec­tive an­ti­body treat­ment is fun­da­men­tal­ly im­por­tant to re­duce the dis­ease pro­gres­sion rate to se­vere COVID-19 and help out­pa­tients avoid hos­pi­tal­iza­tion and al­le­vi­ate the bur­den on the health care sys­tem. We have com­menced the de­vel­op­ment of a neu­tral­iz­ing an­ti­body cock­tail with CT-P59 against new emerg­ing strains in the UK and South Africa and we will con­tin­ue to fur­ther in­ves­ti­gate the neu­tral­iz­ing an­ti­bod­ies and oth­er re­spons­es to pro­tect against cur­rent SARS-CoV-2 strains and emerg­ing vari­ants.”

In March, the Eu­ro­pean Med­i­cines Agency an­nounced that the mAb could be used as treat­ment for adults who don’t re­quire sup­ple­men­tal oxy­gen and are at high risk of pro­gress­ing to se­vere Covid-19. The EMA said that most side ef­fects re­port­ed were mild or mod­er­ate, but re­sults weren’t ro­bust enough to reach a con­clu­sion on the med­i­cine’s ben­e­fits.

The com­pa­ny be­gan mass pro­duc­ing the mAb in Sep­tem­ber 2020 in hopes of get­ting emer­gency use au­tho­riza­tion. — Josh Sul­li­van

Pfiz­er/BioN­Tech could have vac­cine tri­al re­sults for younger chil­dren by Sep­tem­ber — re­port

BioN­Tech CEO Ugur Sahin says the com­pa­ny could have a look at how its Pfiz­er-part­nered Covid-19 vac­cine works in ba­bies as young as six months old by Sep­tem­ber, ac­cord­ing to Reuters. 

“In Ju­ly, the first re­sults could be avail­able for the five to 12 year olds, in Sep­tem­ber for the younger chil­dren,” he told the Ger­man mag­a­zine Der Spiegel, per Reuters.

Ear­li­er this month, Pfiz­er and BioN­Tech asked the FDA to ex­pand its EUA to in­clude ado­les­cents 12 to 15 years old.

A cou­ple weeks ago, Mod­er­na said its Phase II/III Teen­COVE study is ful­ly en­rolled with about 3,000 par­tic­i­pants be­tween the ages of 12 and 17 in the US. Mean­while, its Phase II/III Kid­COVE study was still re­cruit­ing chil­dren be­tween 6 months and 11 years old. — Nicole De­Feud­is

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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

Covid-19 roundup: Pfiz­er CEO Bourla to write book about vac­cine arms race; Chi­nese mR­NA shot set for PhI­II tri­al in Mex­i­co

Pfizer CEO Albert Bourla has inked a deal with Harper Business for a book to tell the “behind-the-scenes” story of the company’s race to develop a vaccine, the Associated Press reports.

The book is titled “Moonshot: Inside Pfizer’s Nine-Month Race to Make the Impossible Possible” and is set to be released Nov. 9. Bourla plans to donate the proceeds to charity, the AP reported.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Distribution of Moderna's Covid-19 Vaccine (Photo by Paul Sancya - Pool/Getty Images)

Opin­ion: Ado­les­cents can wait. The US needs to start do­nat­ing Covid-19 vac­cines to needy coun­tries now.

Now that the US is swimming in Covid-19 vaccines and the supply has officially eclipsed the demand, it’s time for America to lead the world and start shipping these excess doses to countries that desperately need them.

Unlike the IP waiver at the World Trade Organization, which Biden now supports and will likely take years to translate into actual shots in arms, the US could easily donate just a tiny fraction of the more than 60 million doses of Pfizer, Moderna and J&J vaccines sitting on American shelves right now.