Feng Zhang, heavy­weight col­lab­o­ra­tors un­veil lat­est CRISPR up­start — a di­ag­nos­tic com­pa­ny

Im­age: David Walt, Todd Gol­ub, Rahul Dhan­da, Feng Zhang, Deb­o­rah Hung. SHER­LOCK


One of the more dra­mat­ic dy­nam­ics in the aca­d­e­m­ic CRISPR world in­volves the Broad In­sti­tute and the Uni­ver­si­ty of Cal­i­for­nia, where Feng Zhang and Jen­nifer Doud­na, two pi­o­neers of the field, have their labs re­spec­tive­ly. As the dust starts to set­tle on their patent dis­pute re­gard­ing ther­a­peu­tic us­es of the gene edit­ing tech, a new storm is brew­ing in the di­ag­nos­tic ap­pli­ca­tions of CRISPR.

Zhang and eight oth­er lead­ing ex­perts in CRISPR, syn­thet­ic bi­ol­o­gy, di­ag­nos­tics and in­fec­tious dis­eases have pulled back the cur­tain on Sher­lock Bio­sciences, a start­up aimed at pro­vid­ing “bet­ter, faster and more af­ford­able” ways to de­tect ge­net­ic sig­na­tures of dis­ease.

The com­pa­ny stands on two foun­da­tion­al tech­nolo­gies: SHER­LOCK, or Spe­cif­ic High-sen­si­tiv­i­ty En­zy­mat­ic Re­porter un­LOCK­ing, was de­vel­oped by Zhang and col­lab­o­ra­tors in­clud­ing co-founders Jonathan Gooten­berg and Omar Abu­dayyeh. Pair­ing CRISPR with the Cas13 en­zyme, the tech­nol­o­gy uti­lizes a guide RNA to find a ge­net­ic se­quence, where Cas13 not on­ly cuts the tar­get but be­gin shriv­el­ing oth­er RNA near­by, cre­at­ing a sig­nal that can then be pre­sent­ed in ob­serv­able forms — such as a line on a pa­per strip.

“Any one tech­nol­o­gy out there had some re­al­ly valu­able at­trib­ut­es in mol­e­c­u­lar di­ag­nos­tics but SHER­LOCK brought all of those to­geth­er,” Rahul Dhan­da, a co-founder and di­ag­nos­tics vet­er­an who took on the CEO role, told me. “It had speed, so you didn’t have to wait days for an in­fec­tious dis­ease re­sult; it had af­ford­abil­i­ty, which meant that you can do on­col­o­gy test­ing in a way that let every­body par­tic­i­pate in those re­sults; and it had sim­plic­i­ty, which means that you can reach peo­ple to do test­ing that couldn’t do it be­fore in de­cen­tral­ized set­tings.”

First in­vent­ed in 2017, an en­hanced ver­sion of SHER­LOCK was de­scribed in a pa­per pub­lished last Feb­ru­ary along­side an­oth­er ex­plain­ing DE­TEC­TR, a sim­i­lar tool that de­ploys Cas12 and a flu­o­res­cent mol­e­cule for de­tec­tion.

Doud­na of UC Berke­ley, who led the work on DE­TEC­TR, de­buted Mam­moth Bio­sciences short­ly there­after with a group of grad stu­dents, some of them from her lab. When we last heard from them, Mam­moth was work­ing with a $23 mil­lion round and back­ing from May­field, NFX, 8VC as well as Ap­ple’s Tim Cook and Grail found­ing CEO Jeff Hu­ber.


Im­age: Omar Abu­dayyeh, Jonathan Gooten­berg, Rahul Dhan­da, James Collins, Par­dis Sa­beti. SHER­LOCK

While com­par­isons with Mam­moth might be in­evitable, Dhan­da says he’s “very con­fi­dent” on the patent side and has faith in Sher­lock’s mul­ti-plat­form ap­proach to en­gi­neer­ing bi­ol­o­gy.

“Now I’ve been in the in­dus­try 20 years, I know how to nav­i­gate this field; it’s a nu­anced enough field that ex­pe­ri­ence mat­ters,” he added. “I would say that when I think about who we should be fo­cused on as com­pe­ti­tion, those are the large play­ers, the es­tab­lished mul­ti-bil­lion dol­lar di­ag­nos­tic com­pa­nies out there, and those are the com­pa­nies that we in­tend to build strong part­ner­ships with if we can find the right com­ple­ment to our goals and theirs.”

Sher­lock now has $35 mil­lion in the bank — half of it in the form of a grant from the Open Phil­an­thropy Pro­ject, which al­so pro­vid­ed an ad­di­tion­al in­vest­ment. As it ex­plores ap­pli­ca­tions in in­fec­tious dis­eases, pre­ci­sion on­col­o­gy and food in­spec­tion, it is on the look­out for “se­lec­tive part­ner­ing” while ad­vanc­ing de­vel­op­ment pro­grams and de­sign­ing new as­says on its own, the com­pa­ny said. So far, that has in­volved every­thing from phar­ma­ceu­ti­cal com­pa­nies look­ing for com­pan­ion di­ag­nos­tics to an­timi­cro­bial de­vel­op­ers seek­ing help with clin­i­cal tri­als to con­sumer health play­ers in search of at-home test­ing. Agri­cul­ture and bio­process test­ing are among the pos­si­bil­i­ties, too.

Dhan­da is still rais­ing cash for Sher­lock’s Se­ries A, which will al­so help fund the sec­ond plat­form in Sher­lock’s ar­se­nal: IN­SPEC­TR (IN­ter­nal Splint-Pair­ing Ex­pres­sion Cas­sette Trans­la­tion Re­ac­tion). James Collins at the Wyss In­sti­tute was cred­it­ed for the tech, which com­pris­es two halves of a cod­ing re­gion that fuse to cre­ate a sig­nalling pro­tein when the tar­get is present, ba­si­cal­ly repli­cat­ing how a cell would gen­er­ate a pro­tein.

In the com­ing year, Dhan­da is al­so plan­ning to hire 6 to 10 peo­ple to ramp up the R&D work cur­rent­ly han­dled by 10 staffers.

Oth­er co-founders in­clude Todd Gol­ub, Deb­o­rah Hung, Par­dis Sa­beti and David Walt — il­lus­tri­ous aca­d­e­mics who make up a team “like none oth­er.”

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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