José Mejía Oneto, Shasqi CEO

A bet­ter way to con­trol where drugs go? In­vestors bet on small biotech's mis­sion to 'click' to­geth­er can­cer meds

While José Mejía One­to was an or­tho­pe­dic surgery res­i­dent at UC Davis, he learned an in­trigu­ing yet frus­trat­ing fact: On­ly small amounts of a drug — in some cas­es just 1% or 2% of what’s ad­min­is­tered — ac­tu­al­ly make it to the tar­get lo­ca­tion.

That con­cern­ing fact left Mejía One­to with one ques­tion, one that would change the tra­jec­to­ry of his en­tire ca­reer — how can we bet­ter con­trol where drugs go?

Ear­ly Thurs­day morn­ing, his start­up Shasqi un­veiled $50 mil­lion in new cash to ex­plore just that. The Se­ries B round brings Shasqi’s to­tal raise up to $60 mil­lion, and should see the biotech’s lead can­di­date in­to a Phase II study in sol­id tu­mors.

Mejía One­to launched Shasqi back in 2015 and homed in on some­thing called “click chem­istry.” The term was coined by No­bel lau­re­ate Karl Bar­ry Sharp­less back in 2001, and Mejía One­to de­scribes it as two com­pounds that “re­act with each oth­er and ig­nore the rest of the world.”

A pa­per in Sci­enceDi­rect de­fines the phe­nom­e­na as “a col­lec­tion of or­gan­ic re­ac­tions that pro­ceed rapid­ly and se­lec­tive­ly un­der mild con­di­tions to co­va­lent­ly link mol­e­c­u­lar com­po­nents.” The “click” refers to the po­ten­tial to join mol­e­cules as if fas­ten­ing a seat belt, ac­cord­ing to a book ti­tled “Flu­o­rine, a key el­e­ment for the 21st cen­tu­ry.”

Shasqi is es­sen­tial­ly look­ing to see if they can in­ject a biopoly­mer mod­i­fied with a click chem­istry reagent in­to the tu­mor site, then mod­i­fy an in­tra­venous­ly ad­min­is­tered drug with the oth­er reagent in the hopes they’ll click.

“It has been tru­ly both an hon­or and a great plea­sure to see that trans­formed from a con­cept and a piece of pa­per to an in­ves­ti­ga­tion­al prod­uct that has been in the clin­ic for more than a year,” Mejía One­to said.

Ear­ly da­ta have sug­gest­ed the ap­proach works in hu­mans, and Mejía One­to ex­pects to launch his lead can­di­date SQ3370 in­to the Phase II por­tion of a Phase I/II study next year. Shasqi’s 15-per­son team ex­pects to fo­cus on soft tis­sue sar­co­ma in the dose ex­pan­sion co­horts, which tends to oc­cur in the arms and legs, mak­ing it more ac­ces­si­ble.

“We ex­pect this ex­pan­sion to open up the path for the plat­form to an­ti­body-based ap­proach­es, im­mune cell en­gagers, ra­dio­phar­ma­ceu­ti­cals and more,” the CEO said.

A slate of pri­vate in­vestors pitched in­to the Se­ries B round, in­clud­ing Ar­cus Bio­sciences pres­i­dent Juan Jaen, and NGM Bio­phar­ma­ceu­ti­cals ex­ec­u­tive chair­man Bill Rieflin.

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

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.
Contact us about your next study.
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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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