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.”

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Troy Wilson, Kura CEO

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.

A Sen­ate bill wants to even an 'un­lev­el play­ing field' for do­mes­tic, for­eign in­spec­tion drop-ins amid back­log

Amid geopolitical tensions between the US and China, two Republican senators are calling for a bill that would aim to strike a balance on domestic and foreign inspection requirements from the FDA.

Sens. Mike Braun (R-IN) and Joni Ernst (R-IA) have penned a bill called the Creating Efficiency in Foreign Inspections Act. It contains a bit of rhetoric, highlighting “communist China” not once, but twice in the release, but states that the goal is to even the playing field between foreign and American manufacturers.

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