Mam­moth Bio­sciences teams with GSK to put Covid-19 CRISPR tests at home, air­ports, bor­ders

The old CRISPR ri­val­ry is back in pan­dem­ic fash­ion.

Two weeks af­ter Feng Zhang-found­ed Sher­lock Bio­sciences launched the first Covid-19 CRISPR test, Jen­nifer Doud­na-found­ed Mam­moth Bio­sciences has part­nered with Glax­o­SmithK­line on their own tests, with plans to even­tu­al­ly roll it out in places like homes and air­ports. Take a swab, get a green light, and you’re good to board.

“You can al­so imag­ine about build­ing a com­pan­ion app, so you’re con­nect­ing to next steps or tele­health” if you test pos­i­tive, Mam­moth CEO and co-founder Trevor Mar­tin told End­points News. “There’s a lot of op­por­tu­ni­ty to re­al­ly in­te­grate in­to the broad­er ecosys­tem. That’s why we’re work­ing with an or­ga­ni­za­tion like GSK — they ob­vi­ous­ly have a glob­al reach to un­der­stand dif­fer­ent needs, how to scale, and are plugged in­to this broad­er ecosys­tem.”

Thus far, the at-home Covid-19 tests in­volved swab­bing and then send­ing the sam­ple out to a re­search lab for the analy­sis. The kits the two com­pa­nies are mak­ing and hop­ing to sub­mit to the FDA by the end of the year would give an an­swer im­me­di­ate­ly. That GSK-Mam­moth vi­sion would mark a turn­ing point not on­ly for the pan­dem­ic — de­mar­cat­ing a world, al­ready ar­tic­u­lat­ed by oth­ers, where di­ag­nos­tic tests are near­ly as com­mon­place as tick­et checks or as tem­per­a­ture read­ings have al­ready be­come in some ar­eas — but al­so for CRISPR it­self.

Jen­nifer Doud­na

In the decade since CRISPR was pi­o­neered by Doud­na and Zhang at UC Berke­ley and MIT, the tech­nol­o­gy has at­tract­ed an al­most mys­ti­cal lore when it ap­peared in the pop­u­lar press: a pow­er­ful tool that can cut and paste the code of life, cure ge­net­ic dis­eases and make dystopic changes to hu­man evo­lu­tion. The tool it­self, though, has so far re­mained in re­search labs, hav­ing been used on pa­tients on­ly in a hand­ful cas­es and con­di­tions. Wide­spread Covid-19 CRISPR tests could have thou­sands of peo­ple us­ing it dai­ly.

”It al­lows you to think even more broad­ly, right? Now we’re start­ing to see peo­ple think about CRISPR as an an­tivi­ral — to find the virus and de­stroy it,” Mar­tin said. “When you start think­ing about CRISPR in these dif­fer­ent ways, it ex­pands the po­ten­tial of CRISPR even more, which is ex­cit­ing be­cause it’s al­ready an ex­treme­ly ver­sa­tile tool.”

That vi­sion, though, may not come for a while. Or a while, by pan­dem­ic de­vel­op­ment stan­dards: 2021. For now, Mam­moth is await­ing a de­ci­sion for the emer­gency use au­tho­riza­tion they filed re­cent­ly, which would make them the sec­ond ap­proved CRISPR di­ag­nos­tic test af­ter Sher­lock and set them up for use in doc­tors of­fices. Zhang has al­so talked about the po­ten­tial for Sher­lock’s test to be used at home, al­though it’s not yet ap­proved for that set­ting.

Feng Zhang

Both Sher­lock and Mam­moth have been work­ing on their tests for months now, with Mam­moth pub­lish­ing their pro­to­col last month, but de­vel­op­ing some­thing that works is not the same as de­vel­op­ing one any per­son could use. To make the ini­tial CRISPR test, Mam­moth took the SARS-CoV-2 genome and scanned it for se­quences that are on the virus but not in hu­mans, se­lect­ing one. It then de­vel­oped a CRISPR tool with a guide pro­tein that, when it sees the se­quence, be­gins cut­ting not on­ly that spe­cif­ic se­quence but oth­er mol­e­cules, to cre­ate more ma­te­r­i­al that can lat­er be picked up by the test.

”You go from bind­ing a sin­gle mol­e­cule — say Covid-19 — to cleav­ing many or­ders of mag­ni­tude more,” Mar­tin said. “It’s a sig­nal am­pli­fi­ca­tion.“ The sam­ple can then be added to a small cas­sette that in­di­cates pos­i­tive or neg­a­tive by giv­ing a col­or change, or in­volve re­porter mol­e­cules that give off flo­res­cence

For an at-home test, though, you have to build a test that does all that but re­quires few mov­ing parts, on­ly es­sen­tial­ly a sin­gle swab and an in­ser­tion. “You want to re­al­ly make sure that this is a test that is tru­ly ac­ces­si­ble; it’s not some­thing where you have a bunch of user steps where you’re kind of mix­ing some­thing and then you’re putting it in this thing and and then you’re tak­ing it over here,” Mar­tin said.

Ex­perts de­bate whether a take-home test will have a large im­pact on pub­lic health and curb­ing fu­ture out­breaks — one Im­pe­r­i­al Col­lege of Lon­don re­port es­ti­mat­ed rou­tine screen­ing of peo­ple with no symp­toms would be most ef­fec­tive in at-risk pop­u­la­tions and there­fore re­duce trans­mis­sion by about a 3rd — but at min­i­mum, the test should add an­oth­er way of get­ting a quick di­ag­no­sis. It works un­der 20 min­utes, as fast as the fastest PCR tests and the re­cent­ly ap­proved anti­gen test. And it can de­tect the virus ear­li­er than an anti­gen test will.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

Endpoints Premium

Premium subscription required

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

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.