Eli Lil­ly teams with an­ti­body up­start Ab­Cellera in coro­n­avirus hunt

As the Covid-19 out­break reach­es of­fi­cial pan­dem­ic lev­els and be­gins to dis­rupt US life in un­prece­dent­ed ways, Eli Lil­ly is join­ing the hunt for a drug that can treat the in­fec­tion.

The lega­cy phar­ma — not typ­i­cal­ly known for a rapid R&D en­gine — is team­ing with a small but well-con­nect­ed an­ti­body start­up out of British Co­lum­bia called Ab­Cellera. Ab­Cellera said they had al­ready iso­lat­ed a lit­tle over 500 po­ten­tial­ly ther­a­peu­tic an­ti­bod­ies from the blood of one of the US pa­tients who re­cov­ered from the virus and will work with Eli Lil­ly on test­ing those and turn­ing the best ones in­to a drug. The NIH and the Vac­cine Re­search Cen­ters will al­low pro­vide sup­port.

Carl Hansen

“We are pulling out all the stops,” Ab­Cellera CEO Carl Hansen told End­points News. “We formed a plan at Eli Lil­ly and the ob­jec­tive is to have the first in-hu­man test­ing by late Ju­ly. If we are suc­cess­ful that would be a world record.”

Ab­Cellera and Lil­ly join a long list of drug­mak­ers rapid­ly search­ing for a treat­ment. Oth­er com­pa­nies, such as Re­gen­eron, are al­so hop­ing to have first in-hu­man test­ing by the sum­mer, but it’s not clear how rapid­ly a treat­ment could be de­ployed even af­ter go­ing through Phase I. Gilead’s ex­per­i­men­tal an­tivi­ral remde­sivir, orig­i­nal­ly de­vel­oped for Ebo­la, is al­ready in test­ing.

Ab­Cellera is on­ly 7 years old, but they’ve al­ready scored dis­cov­ery part­ner­ships with No­var­tis, Glax­o­SmithK­line, Sanofi, Pfiz­er and Gilead, along with a list of small­er biotechs, in­clud­ing De­nali, Har­bour Bio­med, and Au­to­lus. In 2018, they were one of four groups named to pan­dem­ic re­sponse project at the De­fense Ad­vanced Re­search Pro­jects Agency (DARPA). The goal was to build a plat­form that could cre­ate field-ready an­tivi­ral with­in 60 days of iso­lat­ing a virus.

Ab­Cellera’s role was an­ti­body screen­ing and re­fin­ing. The com­pa­ny is built on minia­ture as­says Hansen says al­lows them to rapid­ly screen the blood of in­fect­ed an­i­mals or hu­mans for an­ti­bod­ies against the virus, and then se­lect and en­gi­neer the best one.

Hansen said Ab­Cellera moved quick­ly af­ter the coro­n­avirus out­break be­gan. In Jan­u­ary, they be­gan prepar­ing the prop­er reagents. The next month, they ac­quired a blood sam­ple from one of the first pa­tients to re­cov­er from the coro­n­avirus. They then screened the blood for an­ti­bod­ies, turn­ing up thou­sands of re­sults, and whit­tled those down to 500.

”That ca­pa­bil­i­ty has been build­ing for three years,” Hansen said, re­fer­ring to the DARPA pro­gram. “We’ve pres­sure test­ed it three times.”

Ab­Cellera and Lil­ly will share de­vel­op­ment costs un­til a prod­uct is found, af­ter which Lil­ly will ful­ly cov­er de­vel­op­ment man­u­fac­tur­ing and dis­tri­b­u­tion.

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

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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FDA's ODAC shrugs off ob­jec­tions to Mesoblast's GVHD drug for chil­dren, vot­ing 8-2 in fa­vor and im­prov­ing the odds of an ap­proval

The FDA’s Oncologic Drugs Advisory Committee once again waved through an investigational drug, clearing the potential final hurdle before the agency’s decision.

Thursday’s winner was Mesoblast $MESO, an Australian stem-cell company that submitted its Ryoncil drug for the treatment of steroid refractory acute graft-versus-host disease in children younger than 12. ODAC gave Ryoncil the thumbs up by an 8-2 vote, shrugging off concerns about trial design and pushing aside the need for an additional study.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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