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.”

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,500+ biopharma pros reading Endpoints daily — and it's free.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,500+ biopharma pros reading Endpoints daily — and it's free.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,500+ biopharma pros reading Endpoints daily — and it's free.

Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,500+ biopharma pros reading Endpoints daily — and it's free.