Sev­en plucky di­ag­nos­tics com­pa­nies win a $249M round of con­tracts af­ter sur­viv­ing NI­H's Covid-19 'Shark Tank' com­pe­ti­tion

As US Covid-19 deaths creep past 150,000 and of­fi­cials stress the im­por­tance of con­tact trac­ing, the NIH’s Rapid Ac­cel­er­a­tion of Di­ag­nos­tics (RADx) pro­gram has inked con­tracts to­tal­ing $248.7 mil­lion to ex­pand test­ing ca­pa­bil­i­ties.

The sev­en con­tracts, which were cho­sen “Shark Tank”-style from a pool of 100 pro­pos­als, are part of an ef­fort to bump dai­ly test­ing ca­pac­i­ty to 2% of the coun­try’s pop­u­la­tion by late sum­mer or fall. That would be about 6 mil­lion peo­ple per day, com­pared to the cur­rent 520,000 to 823,000 tests be­ing ad­min­is­tered dai­ly.

In to­tal, about 650 pro­pos­als were sub­mit­ted to the RADx project. Hun­dreds of in­dus­try “sharks” — in­clud­ing some from the Na­tion­al In­sti­tute of Bio­med­ical Imag­ing and Bio­engi­neer­ing’s (NIBIB) Point-of-Care Tech­nol­o­gy Re­search Net­work — eval­u­at­ed ap­pli­ca­tions. The NIH nar­rowed the pack down to 100, and in­tense eval­u­a­tion process be­gan.

On­ly 31 projects made it to Phase I RADx de­vel­op­ment, which in­volved four to six weeks of ini­tial tech­nol­o­gy val­i­da­tion. Sev­en have been pushed to Phase II so far, dur­ing which de­vel­op­ers will scale up fa­cil­i­ties, man­u­fac­ture tech­nolo­gies, and send prod­ucts to mar­ket. More than 20 of the com­pa­nies are still in Phase I, and could climb to Phase II in the com­ing weeks.

Dozens more pro­pos­als in the RADx “in­no­va­tion fun­nel” still have a shot at Phase I or II fund­ing. RADx mon­ey comes from a $1.5 bil­lion NIH ini­tia­tive an­nounced in April, which in­clud­ed $500 mil­lion ear­marked for di­ag­nos­tic de­vel­op­ment.

Alex Azar HHS

“RADx moved in­cred­i­bly quick­ly to se­lect promis­ing tech­nolo­gies through its ‘Shark Tank’ ap­proach, in­vest­ing in tech­nolo­gies that could boost Amer­i­ca’s best-in-the-world COVID-19 test­ing ca­pac­i­ty by mil­lions more tests per day,” HHS Sec­re­tary Alex Azar said in a pre­pared state­ment. “These tech­nolo­gies will help de­liv­er faster re­sults from labs and more and more test re­sults with­in min­utes at the point of care, which is es­pe­cial­ly im­por­tant for set­tings like schools and nurs­ing homes.”

The sev­en tech­nolo­gies cur­rent­ly in Phase II range from point-of-care to lab-based test­ing, and from nasal to sali­va sam­pling. The de­vel­op­ers span from Mass­a­chu­setts to Cal­i­for­nia. Each de­vel­op­er ei­ther has a pend­ing EUA ap­pli­ca­tion, or has re­ceived EUA from the FDA, which said it will pri­or­i­tize re­view of RADx projects.

Mesa Biotech

Mesa says its test will use re­verse tran­scrip­tion-poly­merase chain re­ac­tion (RT-PCR) tech­nol­o­gy to de­tect SARS-CoV-2 from nasal swabs with­in 30 min­utes — all from a palm-sized de­vice. The San Diego-based com­pa­ny de­vel­oped the test at the Los Alam­os Na­tion­al Lab­o­ra­to­ry, us­ing grants from the NIH, NI­AID, and West­ern Re­gion­al Cen­ters for Ex­cel­lence in Biode­fense and Emerg­ing In­fec­tious Dis­eases.

Now it’s full steam ahead. With $15.4 mil­lion from RADx, Mesa will push the clin­i­cal de­ploy­ment of its test on an ac­cel­er­at­ed time­line.

Quidel Cor­po­ra­tion

Quidel Cor­po­ra­tion’s take on point-of-care test­ing in­volves im­muno­flu­o­res­cence-based lat­er­al flow im­munoas­say tech­nol­o­gy, used to iden­ti­fy nu­cle­o­cap­sid pro­teins from SARS-CoV-2. The Sofia SARS Anti­gen FIA test kit re­ports re­sults from nasal swabs with­in 15 min­utes, and the com­pa­ny’s Read Now or Batch Test Mode can re­turn re­sults for up to 50 sam­ples in an hour. Quidel, head­quar­tered in San Diego, de­vel­oped the first anti­gen test to win FDA ap­proval in May.

The NIH’s $71 mil­lion con­tract will fund the ex­pan­sion of Quidel’s man­u­fac­tur­ing lines in San Diego, in­creas­ing its out­put from 84 mil­lion test cas­settes per year to more than 220 mil­lion. Quidel’s line of FDA-ap­proved as­says in the US in­cludes in­fluen­za A and B, res­pi­ra­to­ry syn­cy­tial virus (RSV), group A strep, and a 15-minute fin­ger-stick whole blood test for Ly­me dis­ease.

Tal­is Bio­med­ical Cor­po­ra­tion

Tal­is Bio­med­ical pro­duces the third point-of-care test in the RADx pipeline — a mul­ti­plexed car­tridge that de­tects SARS-CoV-2 us­ing isother­mal am­pli­fi­ca­tion of vi­ral RNA and an op­ti­cal de­tec­tion sys­tem. The Men­lo Park, CA-based com­pa­ny inked a $25 mil­lion con­tract for its Tal­is One Covid-19 test, which promis­es re­sults with­in 30 min­utes that are saved on the cloud. Though Tal­is cur­rent­ly has its sights set on Covid-19, it may pur­sue in­fluen­za, STIs, and oth­er in­fec­tions as fu­ture in­di­ca­tions.

Gink­go Bioworks

Gink­go Bioworks took home a $40 mil­lion con­tract to ex­pand its op­er­a­tional ca­pac­i­ty for large-scale Covid-19 test­ing at its au­to­mat­ed fa­cil­i­ties. The Boston-based biotech plans scale up to 50,000 tests per day in De­cem­ber, then 100,000 per day by year’s end. Re­sults are pro­vid­ed with­in 24 to 48 hours of sam­ple col­lec­tion.

Vol­ume is where Gink­go shines. Its next-gen­er­a­tion se­quenc­ing equip­ment (NGS) is de­signed to process many DNA and RNA sam­ples on the same ma­chine, al­low­ing thou­sands of tests to oc­cur at once. In May, Il­lu­mi­na pumped $70 mil­lion in­to the com­pa­ny to build in­fra­struc­ture for its au­to­mat­ed test­ing labs.

He­lix Op­Co

He­lix Op­Co will use $33.4 mil­lion in NIH fund­ing to up its test­ing ca­pac­i­ty to 100,000 per day by the fall. The plan is to ship nasal swab kits in bulk to pub­lic health de­part­ments, health care sys­tems, em­ploy­ers and more, and re­turn re­sults be­tween 24 and 48 hours lat­er.

For now, Cal­i­for­nia-based He­lix us­es re­al-time RT-PCR test­ing to qual­i­ta­tive­ly de­tect nu­cle­ic acid from SARS-CoV-2 in up­per res­pi­ra­to­ry pa­tients. But it has al­so filed an EUA re­quest for its Covid-19 NGS test, a more sen­si­tive test based on Oc­tant Bio’s “Swab­Seq” tech­nol­o­gy.

Flu­idigm Cor­po­ra­tion

Flu­idigm se­cured a con­tract of up to $37 mil­lion to up­scale pro­duc­tion of its Bio­mark HD mi­croflu­idics tech­nol­o­gy for Covid-19 test­ing, with $12 mil­lion in ini­tial fund­ing based on com­ple­tion of mile­stones. One of Flu­idigm’s plat­forms can test 6,000 sam­ples in 24 hours, “with low­er reagent re­quire­ments than com­pa­ra­ble sys­tems,” ac­cord­ing to the San Fran­cis­co-based com­pa­ny’s web­site.

Mam­moth Bio­sciences

An up­scale is in Mam­moth Bio­sciences’ fu­ture. The San Fran­cis­co-based biotech will ex­pand man­u­fac­tur­ing of its DE­TEC­TR test, which us­es CRISPR tech­nol­o­gy to iden­ti­fy nu­cle­ic acids in­dica­tive of SARS-CoV-2. The ex­pan­sion is in line with Mam­moth’s goal to in­crease and ac­cel­er­ate test­ing na­tion­wide us­ing its mech­a­nisms in com­mer­cial labs.

Mam­moth part­nered with Glax­o­SmithK­line in May to de­vel­op the CRISPR-based tests. The com­pa­ny en­vi­sioned a quick swab test for use in homes or even air­ports. The Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co re­cent­ly re­ceived EUA ap­proval to use the DE­TEC­TR reagent set.

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

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.

Roche, Pfiz­er top list of ESG lead­ers in pa­tient group­s' view, but many still think phar­mas can do bet­ter

The rise of pharma environmental, social and governance (ESG) efforts in the past two years has been meteoric as investors turn their attention to sustainable funding. However, investors aren’t the only ones watching. Patients are beginning to tune into pharmas’ ESG promises too.

Patient advocacy groups familiar with ESG regard it as an important issue and want to be included in helping pharma companies set ESG policies and targets, according to a new report from PatientView. That’s quite different from what the investment community wants across a variety of Gartner’s defined financial, competitive, strategic and perception goals.