Carl Hansen, AbCellera CEO (AbCellera)

Lil­ly's Covid-19 part­ner Ab­Cellera is tak­ing a new an­ti­body in­to the clin­ic in the hopes it can tack­le all vari­ants

As the virus be­hind the Covid-19 pan­dem­ic con­tin­ues to mu­tate in­to sev­er­al vari­ants of con­cern, the com­pa­ny be­hind Eli Lil­ly’s bam­lanivimab an­ti­body treat­ment is look­ing to stay ahead of the curve.

Ab­Cellera is push­ing for­ward with a new mon­o­clon­al an­ti­body can­di­date for Covid-19 that it says can neu­tral­ize all cur­rent­ly known vari­ants, mov­ing the pro­gram known as LY-CoV1404 in­to its first clin­i­cal tri­als, the Van­cou­ver-based biotech said Tues­day morn­ing. The pro­gram will join Lil­ly’s on­go­ing Blaze-4 study where it will be eval­u­at­ed in mild to mod­er­ate Covid-19 cas­es.

CEO Carl Hansen didn’t say whether or not the duo plan to even­tu­al­ly move the new­er an­ti­body in­to more se­vere Covid-19 pa­tients, but em­pha­sized the need to ad­min­is­ter an­ti­body treat­ments as quick­ly as pos­si­ble.

“Un­for­tu­nate­ly at this point, the an­ti­bod­ies that have been test­ed in pa­tients once they’re acute and hos­pi­tal­ized, es­sen­tial­ly all an­ti­bod­ies have shown lit­tle, if any, ef­fi­ca­cy,” Hansen said. “I think one of the key things the sci­en­tif­ic com­mu­ni­ty has learned is that an­ti­body ther­a­pies are re­mark­ably ef­fec­tive at keep­ing peo­ple out of the hos­pi­tal, keep­ing them from pro­gress­ing to ill­ness and keep­ing them from death.”

LY-CoV1404 will be test­ed as a monother­a­py and in com­bi­na­tion with the Lil­ly cock­tail that’s cur­rent­ly au­tho­rized by the FDA — bam­lanivimab and ete­se­vimab, Hansen added. There’s al­so the po­ten­tial to ad­min­is­ter the new an­ti­body as a sub­cu­ta­neous in­jec­tion rather than IV in­fu­sion, which would ease the bur­den on some com­mu­ni­ties that had need­ed to set up in­fu­sion cen­ters.

Lil­ly first teamed up with Ab­Cellera back in March 2020 just as the Covid-19 pan­dem­ic start­ed af­fect­ing every­day life in the US. The biotech had been able to iden­ti­fy a po­ten­tial ther­a­py rather quick­ly thanks to its ac­qui­si­tion of a blood sam­ple from a Covid-19 pa­tient the pre­vi­ous month.

Their part­ner­ship first bore fruit with bam­lanivimab, a mon­o­clon­al an­ti­body dis­cov­ered by Ab­Cellera and scaled up in man­u­fac­tur­ing by Lil­ly. Giv­en the huge un­knowns about Covid-19 at the start of the pan­dem­ic, Lil­ly and Ab­Cellera be­gan test­ing the treat­ment in hos­pi­tal­ized pa­tients as well as those not hos­pi­tal­ized, much like oth­er com­pa­nies in­ves­ti­gat­ing po­ten­tial ther­a­pies.

Though bam­lanivimab showed poor re­sults in tri­als for more se­vere cas­es, the an­ti­body proved ef­fec­tive in keep­ing pa­tients out of the hos­pi­tal and earned an EUA as a monother­a­py last No­vem­ber. The pair then se­cured an­oth­er EUA for bam­lanivimab in com­bi­na­tion with ete­se­vimab in Feb­ru­ary.

As the num­ber of coro­n­avirus vari­ants grew, how­ev­er, con­cerns over bam­lanivimab’s ef­fec­tive­ness be­gan to mount. Sev­er­al states stopped giv­ing out the monother­a­py ver­sion of the an­ti­body in March be­fore the US gov­ern­ment, in part­ner­ship with Lil­ly, stopped dis­tri­b­u­tion al­to­geth­er lat­er that month. The cock­tail with ete­se­vimab re­mains au­tho­rized and in cir­cu­la­tion.

That’s where Ab­Cellera hopes the new an­ti­body will be able to step in. Ab­Cellera had been work­ing on find­ing new­er can­di­dates to deal with the vari­ants as bam­lanivimab de­vel­op­ment pro­ceed­ed, Hansen said, and he be­lieves they’ve found the key with LY-CoV1404.

This an­ti­body works by tar­get­ing a part of the coro­n­avirus spike pro­tein that has re­mained the same in each of the vari­ants. Ab­Cellera not­ed it iden­ti­fied two spe­cif­ic amino acid po­si­tions that have on­ly mu­tat­ed about 0.027% of the time, as of April 2021, which al­lows it to neu­tral­ize each of the coro­n­avirus vari­ants that first emerged in the UK, South Africa, Brazil, Cal­i­for­nia and New York, Hansen said.

All of the avail­able Covid-19 in­fo al­lowed Ab­Cellera to find this spike pro­tein re­gion rel­a­tive­ly quick­ly, he added. And even though it’s dif­fi­cult to pre­dict whether or not this re­gion will mu­tate in the fu­ture, Hansen said, the new an­ti­body will have a lot of “stay­ing pow­er.”

“A year ago we knew very lit­tle about the virus and about the im­mune re­sponse to it,” Hansen said. “If we found that an­oth­er vari­ant came out, we be­lieve we are, I would say, unique­ly po­si­tioned to evolve with the pan­dem­ic and find the next an­ti­body ther­a­py.”

The news from Ab­Cellera comes as their ri­vals at Re­gen­eron con­tin­ue to make progress with Covid-19 an­ti­bod­ies as well. Back in March, the FDA said that the Re­gen­eron cock­tail had proved least sus­cep­ti­ble to vari­ants among au­tho­rized an­ti­body treat­ments, and the com­pa­ny is push­ing for­ward with pro­phy­lac­tic tri­als.

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.