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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; 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.

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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.