Ex­clu­sive: Gink­go teams with un­known up­start in hunt for Covid-19 an­ti­body

Gink­go Bioworks, with its vast ware­hous­es of au­to­mat­ed ro­bots and biore­ac­tors, has played a be­hind-the-scenes role in the an­ti-Covid fight since the start of the pan­dem­ic. They’ve helped pro­duce the mR­NA for Mod­er­na’s mR­NA vac­cine, joined a con­sor­tium to help dis­cov­er and an­a­lyze an­ti­bod­ies, and they’ve qui­et­ly laid out grand plans to use Il­lu­mi­na ma­chines to test mil­lions of Amer­i­cans per day.

Now, for the first time, the syn­thet­ic bi­ol­o­gy be­he­moth is back­ing a Covid-19 drug, join­ing forces with a biotech you’ve nev­er heard of to do so.  They’ll work with To­tient, an an­ti­body-fo­cused start­up that is just emerg­ing from stealth mode to­day, to turn their al­ter­nate means of gen­er­at­ing virus-neu­tral­iz­ing in­to a treat­ment that could po­ten­tial­ly treat or tem­porar­i­ly pre­vent in­fec­tion. It’s a small part of a larg­er strat­e­gy Gink­go hopes can both make a broad im­pact on the lat­ter sea­son of the pan­dem­ic.

Naren­dra Ma­heshri

“We’re hop­ing Gink­go be­comes a house­hold name in the next 5 months,” Naren­dra Ma­heshri, Gink­go’s head of mam­malian bi­ol­o­gy, told End­points News. 

Gingko hasn’t his­tor­i­cal­ly de­vel­oped drugs in­de­pen­dent­ly, but rather part­nered with oth­er com­pa­nies that might ben­e­fit from ac­cess to their syn­thet­i­cal bi­ol­o­gy and an­a­lyt­i­cal plat­forms. Ac­cord­ing­ly, when the pan­dem­ic start­ed, they didn’t pur­sue an in­di­vid­ual pro­gram but in­stead be­gan reach­ing out to a host of com­pa­nies, of­fer­ing $25 mil­lion worth of work at their foundry for Covid-19 di­ag­nos­tic, ther­a­peu­tic and vac­cine projects. Specif­i­cal­ly, on drugs, they de­cid­ed to fo­cus on neu­tral­iz­ing an­ti­bod­ies — the same place Eli Lil­ly, Vir, As­traZeneca, Am­gen and Re­gen­eron were throw­ing their weight.

Most of these com­pa­nies de­rive neu­tral­iz­ing an­ti­bod­ies from the blood of sur­vivors, sam­pling which pro­teins the body nat­u­ral­ly made in re­sponse to in­fec­tion and sift­ing out the best ones. Ma­heshri said most of the re­searchers they spoke to used that ap­proach.

By con­trast, To­tient de­rives an­ti­bod­ies from what are known as ter­tiary lym­phoid struc­tures — ba­si­cal­ly ac­cu­mu­la­tions of im­mune cells that can form in places of height­ened in­flam­ma­tion, such as near a tu­mor or at the site of in­fec­tion. In the case of Covid-19, that’s the lungs. So in­stead of an­a­lyz­ing B cells in the blood for an­ti­bod­ies, they look for an­ti­bod­ies from flu­id in the lungs.

The idea both To­tient and Gink­go are bank­ing on — one they say has al­ready been borne out in cell lines — is that be­cause these are the an­ti­bod­ies that were in the hu­man–SARS-CoV-2 bat­tle­field, they will be most at­tuned to neu­tral­iz­ing the virus.

Deniz Kur­al

“We are sam­pling these an­ti­bod­ies that were di­rect­ly in­volved in the tis­sues un­der at­tack,” To­tient CEO Deniz Kur­al told End­points. “At least in our ex­per­i­ments … a lot of them are binders and they tend to be more dis­ease rel­e­vant.”

To­tient is al­so able to de­rive an­ti­bod­ies by look­ing at RNA from across tis­sue, as op­posed to just from a sin­gle cell, which both com­pa­nies say can be an ad­van­tage. Ma­heshri al­so not­ed the feed­back loop they’ve de­vel­oped to im­prove on ini­tial can­di­dates.

“They not on­ly have an­ti­body se­quences they re­con­struct but they al­so have in­for­ma­tion about the pa­tient, their im­mune re­sponse, how long they were in the hos­pi­tal,” he said.  “So our hits then help them re­fine their al­go­rithms to po­ten­tial­ly pull out po­ten­tial­ly even bet­ter an­ti­body se­quences, which he can then put back in­to our pipeline.”

So far, Gink­go has al­ready syn­the­sized and an­a­lyzed over 200 an­ti­bod­ies To­tient iden­ti­fied from the lungs of Covid-19 pa­tients, test­ing them against pseudovirus in cell lines. Nei­ther would dis­close the re­sults, but Ma­heshri said “they look very good.”

Gink­go doesn’t bring drugs in­to the clin­ic, so for now To­tient is look­ing for a part­ner to bring in­to the clin­ic in ear­ly 2021. Ma­heshri not­ed, though, that Gink­go is work­ing on meth­ods to scale up an­ti­body pro­duc­tion, leav­ing a door open for a part­ner­ship down the road. Sev­er­al an­ti­bod­ies are al­ready in the clin­ic, with Eli Lil­ly and Re­gen­eron near­ing ef­fi­ca­cy da­ta, but far more will be need­ed to match na­tion­al and glob­al de­mand. The an­ti­bod­ies found in lung flu­id are al­so dif­fer­ent from the ones found in blood, the com­pa­nies said, mean­ing they could be used in com­bi­na­tion with more ad­vanced can­di­dates.

Ankit Sax­e­na

To­tient, mean­while, is al­so work­ing on can­cer — their main longterm fo­cus. Found­ed by Kur­al and CBO James Si­et­stra, a pair of vet­er­ans from the bio­an­a­lyt­ics firm Sev­en Bridges, the com­pa­ny has an­a­lyzed these struc­tures in pa­tient sam­ples to de­vel­op hun­dreds of can­cer an­ti­bod­ies. They’ve set­tled on three pre­clin­i­cal can­di­dates and will use $10 mil­lion in seed fund­ing to ad­vance them fur­ther. A Se­ries A is in the works.

Gink­go, mean­while, has oth­er po­ten­tial ther­a­peu­tic and vac­cine part­ner­ships in the works, said Ankit Sax­e­na, Gink­go’s di­rec­tor of phar­ma busi­ness de­vel­op­ment. They’ve an­nounced plans to open up their first ma­jor test­ing fa­cil­i­ties in Oc­to­ber.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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