Covid-19 roundup: As­traZeneca's Farx­i­ga fails PhI­II test; Sup­ply deal for Eli Lil­ly's so­lo bam­lanivimab of­fi­cial­ly can­celed

Around the same time As­traZeneca struck up a vac­cine part­ner­ship with Ox­ford last April, the phar­ma gi­ant al­so put to­geth­er a game plan to de­vel­op treat­ments — both new and re­pur­posed — for Covid-19. One of them has now end­ed in fail­ure.

The Phase III DARE-19 tri­al re­cruit­ed 1,250 pa­tients hos­pi­tal­ized with Covid-19 over the past year and gave half of them the di­a­betes drug Farx­i­ga on top of stan­dard of care ther­a­py.

When com­pared to those re­ceiv­ing place­bo, the drug didn’t hit sta­tis­ti­cal sig­nif­i­cance in ei­ther of the pri­ma­ry end­points: pre­vent­ing mea­sur­ing or­gan dys­func­tion and all cause mor­tal­i­ty, or im­prov­ing re­cov­ery (as mea­sured by a change in clin­i­cal sta­tus) at 30 days.

Fo­cus­ing on the bright side, Mene Pan­ga­los, EVP of bio­phar­ma­ceu­ti­cals R&D, not­ed: “Pri­or to the DARE-19 Phase III tri­al, there was lit­tle da­ta on the use of SGLT2 in­hibitors in hos­pi­talised pa­tients with COVID-19 and we have now helped to fill this knowl­edge gap.”

Mikhail Kosi­borod, the prin­ci­pal in­ves­ti­ga­tor of the tri­al and the VP of re­search at As­traZeneca part­ner Saint Luke’s Mid Amer­i­ca Heart In­sti­tute, echoed Pan­ga­los and called the find­ings “very in­ter­est­ing and valu­able.” De­tails are due to be re­leased at the Amer­i­can Col­lege of Car­di­ol­o­gy Sci­en­tif­ic Ses­sions in May.

While orig­i­nal­ly de­signed as a di­a­betes pill, Farx­i­ga has been shown across large stud­ies to have car­dio and re­nal pro­tec­tive ef­fects not just in that pop­u­la­tion but al­so for those with heart fail­ure with re­duced ejec­tion frac­tion and chron­ic kid­ney dis­ease (CKD). Co­in­ci­den­tal­ly, sci­en­tists had ob­served that Covid-19 pa­tients with “car­diac, re­nal and meta­bol­ic co­mor­bidi­ties” tend­ed to have poor out­comes — lead­ing As­traZeneca to test whether Farx­i­ga may help in this set­ting as well.

Like a slew of oth­er com­mer­cial drugs that bio­phar­ma com­pa­nies big and small tried to re­pur­pose, it didn’t. As­traZeneca it­self has al­ready con­clud­ed that Calquence, the block­buster BTK in­hibitor ap­proved for can­cer, made lit­tle dif­fer­ence in mor­tal­i­ty or sav­ing Covid-19 pa­tients from res­pi­ra­to­ry fail­ure.

While the phar­ma gi­ant didn’t spec­i­fy the next steps, it seems to im­ply that this will mark the end of the Farx­i­ga pro­gram in Covid-19.

US gov­ern­ment re­jigs an­ti­body sup­ply deal with Eli Lil­ly 

Days af­ter the US gov­ern­ment and Eli Lil­ly agreed to halt all dis­tri­b­u­tion of bam­lanivimab as a monother­a­py, the com­pa­ny said of­fi­cials have of­fi­cial­ly re­vised the an­ti­body sup­ply deal.

That means the pur­chase agree­ment for bam­lanivimab will be ter­mi­nat­ed, the com­pa­ny said in a state­ment, can­cel­ing the planned de­liv­ery of 350,836 dos­es the orig­i­nal agree­ment had called for.

Con­cerns of bam­lanivimab’s di­min­ished ef­fi­ca­cy against cer­tain coro­n­avirus vari­ants first led the US to stop di­rect or­der­ing of bam­lanivimab alone in three states, be­fore ex­tend­ing that ban to the whole coun­try. In­stead, hos­pi­tals could or­der ei­ther bam­lanivimab and ete­se­vimab to­geth­er or ete­se­vimab alone to pair with any re­main­ing dos­es of bam­lanivimab on hand.

The arrange­ment is now cod­i­fied in the mod­i­fied con­tract.

First de­vel­oped by Ab­Cellera, bam­lanivimab was the first mon­o­clon­al an­ti­body to gain an emer­gency use au­tho­riza­tion at the FDA. Lil­ly sub­se­quent­ly paired it with ete­se­vimab, which orig­i­nat­ed from Chi­na’s Jun­shi, gen­er­at­ing a sol­id slate of com­bo da­ta that led to an­oth­er EUA, al­so for mild to mod­er­ate Covid-19. To­geth­er, the two reg­i­mens were the sub­ject of a $1.2 bil­lion sup­ply deal.

As con­cerns grew that cer­tain vari­ants could evade an­ti­body treat­ments, the FDA has di­rect­ed both Lil­ly and Re­gen­eron to mon­i­tor ge­nom­ic data­base(s) for the emer­gence of glob­al vi­ral vari­ants and track how well their drugs can tack­le those vari­ants.

Chi­na is ready to join the mR­NA race

As Fo­s­un Phar­ma pre­pares to push BioN­Tech’s Covid-19 vac­cine to­ward an ap­proval in Chi­na, a se­nior in­dus­try fig­ure says home­grown mR­NA play­ers will al­so be ready to jump in the game soon.

“We ful­ly ex­pect that there is a high pos­si­bil­i­ty that a do­mes­tic mR­NA vac­cine will hit the mar­ket by this year,” Feng Duo­jia, pres­i­dent of the Chi­na As­so­ci­a­tion of Vac­cines, told the South Chi­na Morn­ing Post.

One can­di­date joint­ly de­vel­oped by the Acad­e­my of Mil­i­tary Sci­ence, Wal­vax Biotech­nol­o­gy and Suzhou Abo­gen Bio­sciences has been through Phase II tri­als with “sat­is­fac­to­ry” re­sults, he said, with Phase III tri­als un­der­way over­seas. An­oth­er from Shang­hai-based Stemir­na went in­to the clin­ic last month.

Fo­s­un, mean­while, is sort­ing through da­ta from Phase II tri­als con­duct­ed in Jiang­su province, SCMP re­port­ed. The plan is to com­bine those with Phase III re­sults from over­seas in its reg­u­la­to­ry fil­ing.

While Fo­s­un start­ed off as the de­vel­op­er and dis­trib­u­tor of BioN­Tech’s vac­cines — hav­ing start­ed de­liv­er­ing dos­es made in Ger­many to Hong Kong and Macau — the com­pa­ny has inked a deal to pro­duce lo­cal­ly.

“The prepa­ra­tions at the pro­duc­tion fa­cil­i­ty are ready,” Feng added. “Af­ter ef­fec­tive re­sults are ob­tained through these tri­als, an ap­pli­ca­tion will be sub­mit­ted to the rel­e­vant gov­ern­ment agency im­me­di­ate­ly, with the hope to start do­mes­tic pro­duc­tion of the for­eign vac­cine in Chi­na.”

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

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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Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

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.