Jason Kelly, Gingko Bioworks CEO (Mike Blake/Reuters via Adobe)

Ex­clu­sive: Eye­ing big Covid-19 test­ing ex­pan­sion, Gink­go rolls out 50M rapid anti­gen di­ag­nos­tics

In what they hope will be a key part of an ex­ten­sive ef­fort to boost Covid-19 test­ing in the US, Gink­go Bioworks is ac­quir­ing and dis­trib­ut­ing 50 mil­lion rapid anti­gen tests that can po­ten­tial­ly be used for virus sur­veil­lance in schools and com­mu­ni­ties and for quick, on the ground di­ag­noses.

The tests, de­vel­oped by SD Biosen­sor, are in line with pro­pos­als from the Rock­e­feller Foun­da­tion and Har­vard epi­demi­ol­o­gists, among oth­ers, to blan­ket the coun­try with fast, low-cost tests. Al­though not yet au­tho­rized in the US, they are a key part of test­ing ef­forts from the Bill and Melin­da Gates Foun­da­tion, who an­nounced plans last month to dis­trib­ute 120 mil­lion of them in low and mid­dle in­come coun­tries. Roche has com­mer­cial­ized the di­ag­nos­tic in Eu­rope.

The tests can im­me­di­ate­ly be used for sur­veil­lance, where schools, of­fices or com­mu­ni­ties can mon­i­tor for out­breaks, as some places now do with waste­water test­ing and oth­er tech­nolo­gies. With an EUA, it could al­so be used to give in­di­vid­ual yes/no an­swers.

Gink­go’s new Covid-19 au­to­mat­ed, Il­lu­mi­na-equipped test­ing fa­cil­i­ty in Boston, set to open next month

Click on the im­age to see the full-sized ver­sion

Gink­go CEO Ja­son Kel­ly said he en­vi­sioned de­ploy­ing the tests in com­mu­ni­ties in the same way some north­east col­leges used once or twice-a-week test­ing to safe­ly re­open in the fall. He not­ed the US doesn’t even have the ca­pac­i­ty now to test a frac­tion of schools.

“If you look, in the US, it’s 20 mil­lion stu­dents and staff as­so­ci­at­ed with col­leges. So if you were test­ing them twice a week, it’d be about 5 mil­lion a day, and our na­tion­al ca­pac­i­ty for test­ing right now is a mil­lion tests a day,” Kel­ly told End­points News. “So if you’re go­ing to ac­tu­al­ly do some­thing like what was done for a small num­ber of col­leges na­tion­wide, you’ve got­ta bring on­line stuff like this.”

A decade-old up­start out of MIT, Gink­go grew to uni­corn sta­tus at the tail end of 2019 off the ro­bot­ic fac­to­ries it built to scale syn­thet­ic bi­ol­o­gy, sup­port­ing ap­pli­ca­tions on every­thing from fer­til­iz­er and per­fumes to nov­el an­tibi­otics and en­gi­neered mi­crobes.

Dur­ing the pan­dem­ic, though, the com­pa­ny has con­cen­trat­ed its ef­forts on di­ag­nos­tics. Most promi­nent­ly, in the spring, they un­veiled plans to use their ar­ray of Il­lu­mi­na se­quencers as a new kind of di­ag­nos­tic. With back­ing from the NIH’s RADx ini­tia­tive, Gink­go has built a new au­to­mat­ed fac­to­ry ded­i­cat­ed to that pur­pose in Boston. Once on­line next month, it should be able to process about 100,000 tests per day, or a full 10% in­crease in the na­tion’s cur­rent test­ing ca­pac­i­ty.

Ide­al­ly, Kel­ly said, they’d like to even­tu­al­ly use it for front-end pool test­ing, where a school or an of­fice mix­es sam­ples from, say, 10 dif­fer­ent peo­ple and tests them all to­geth­er in an ef­fort to get a broad sense of whether there’s an out­break.

“What you’re re­al­ly see­ing now is peo­ple put like 6 swabs in a tube and ship it to the lab,” Kel­ly said, laugh­ing. “But that’s a start. In a per­fect world they would al­so fig­ure out how to get the swabs out of there and just send a sam­ple to the lab that didn’t have swabs. But it’s start­ing to hap­pen.”

In the mean­time, they’re push­ing for­ward with the anti­gen plan. The tests they are now rolling out hold the same draw­backs that have swirled around anti­gen tests for months: the po­ten­tial for too many false pos­i­tives and too many false neg­a­tives. (Kel­ly, echo­ing ex­perts like Har­vard epi­demi­ol­o­gist Michael Mi­na, thinks the neg­a­tives aren’t much of a con­cern, as we’re al­ready miss­ing every­one we don’t test, though he thinks the pos­i­tives are worth watch­ing. “If you’re quar­an­ti­ning 5% of your work­force every day, it’s not go­ing to work,” he said.)

Gink­go al­so re­viewed the pa­per tests that E25Bio de­vel­ops and that Mi­na has been push­ing as a way to test near­ly every Amer­i­can every day. They de­cid­ed, though, that those weren’t yet read to scale — one of the key ad­van­tages of the SD Biosen­sor tech. Un­like some of the anti­gen tests from BD or Quidel, the SD Biosen­sor tests re­quire a much sim­pler de­vice to read. That could al­low for much broad­er man­u­fac­tur­ing and dis­tri­b­u­tion, sim­i­lar to the Ab­bott tests re­cent­ly pur­chased en masse by the gov­ern­ment.

The read­er “ba­si­cal­ly cre­ates a bot­tle­neck in how many tests you can ac­tu­al­ly do per day,” Kel­ly said. “If you can do it with­out a read­er then your bot­tle­neck is pret­ty much how many you can man­u­fac­ture.”

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Ramy Farid, Schrödinger CEO (Schrödinger)

Bris­tol My­ers fronts new Schrödinger al­liance with $55M up­front, ex­pand­ing pre­ci­sion on­col­o­gy pro­file

Bristol Myers Squibb has a new R&D partner, one to which they’re paying a pretty penny to use their discovery platform.

The pharma company is doling out $55 million upfront to Schrödinger $SDGR to work on up to five small molecules, with the potential for $2.7 billion in milestone payments. Schrödinger’s initial targets include HIF-2 alpha and SOS1/KRAS for a type of kidney cancer and KRAS-driven cancers, respectively.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.