Dan Rhodes, Strata Oncology CEO (Strata)

Mer­ck and Pfiz­er back a Michi­gan star­tup's mis­sion to ad­vance tu­mor pro­fil­ing

Dan Rhodes was lead­ing can­cer se­quenc­ing at Ther­mo Fish­er Sci­en­tif­ic when he no­ticed that, de­spite the rush of phar­ma com­pa­nies de­vel­op­ing tar­get­ed ther­a­pies, most pa­tients weren’t get­ting the right test­ing — and there­fore miss­ing out on what could be the best treat­ments based on their spe­cif­ic tu­mor pro­file.

In 2015, he set out to change that. With the sup­port of Ther­mo Fish­er ex­ec­u­tives and the help of a cou­ple ex­perts in the field, Rhodes launched Stra­ta On­col­o­gy to ad­vance DNA and RNA se­quenc­ing. The team has since at­tract­ed some im­pres­sive back­ers, in­clud­ing both Pfiz­er and Mer­ck. And on Wednes­day, they un­veiled a $90 mil­lion Se­ries C round to build out a com­mer­cial team and fu­el clin­i­cal tri­als for new RNA-based treat­ment se­lec­tion tests.

“Our mis­sion is to de­liv­er the best pos­si­ble treat­ment to each pa­tient with can­cer as ear­ly as pos­si­ble,” Rhodes told End­points News. 

Tu­mor pro­fil­ing be­gins with a sam­ple of tu­mor tis­sue, from which Stra­ta can se­quence DNA and RNA to look for mu­ta­tions known to play a role in can­cer. They’re es­pe­cial­ly look­ing for mu­ta­tions that are al­ready tar­getable by ex­ist­ing or in­ves­ti­ga­tion­al ther­a­pies. The whole process takes about sev­en busi­ness days, and the idea is to give the pa­tient the crit­i­cal in­for­ma­tion they need by their first fol­low-up vis­it.

“It’s re­al­ly these RNA prod­ucts that re­al­ly set Stra­ta apart,” Rhodes said, adding that se­quenc­ing com­pa­nies have his­tor­i­cal­ly fo­cused on DNA. That, and the fact that the com­pa­ny’s first tu­mor pro­fil­ing test, StrataNGS, re­quires just a small amount of tis­sue —  just a square 2 mm.

“What we see in the re­al world is up­wards of half of sam­ples are small­er than the tis­sue re­quire­ments for oth­er lead­ing tests,” he said, adding that the re­searchers should be able to do DNA and quan­ti­ta­tive RNA test­ing si­mul­ta­ne­ous­ly from the same small tis­sue sam­ple.

Some of the Se­ries C funds will al­so go to­ward the com­pa­ny’s blood-based re­cur­rent mon­i­tor­ing tests, where the idea is to move pre­ci­sion treat­ment se­lec­tion from late-stage ad­vanced can­cer to ear­li­er stages by de­tect­ing can­cer that’s des­tined to re­cur.

Af­ter pro­fil­ing a tu­mor, Stra­ta can help con­nect pa­tients to clin­i­cal tri­als that might suit them, through a net­work of phar­mas work­ing on pre­ci­sion med­i­cines.

“For us the test­ing that we do, while that’s our main busi­ness, it’s re­al­ly a means to that more im­por­tant end of get­ting the right treat­ment,” Rhodes said. “This is re­al­ly a win-win: The health sys­tems in our net­work gain ac­cess to these cut­ting-edge clin­i­cal tri­als, and the phar­mas gain ac­cess to this net­work of health sys­tems where the ma­jor­i­ty of pa­tients have been test­ed with Stra­ta. We’ve got da­ta on the bio­mark­er pro­files and can then re­al­ly fa­cil­i­tate con­sid­er­a­tion of pa­tient screen­ing and en­roll­ment in­to these phar­ma tri­als.”

Welling­ton Man­age­ment led the round, with a hand from Cor­morant As­set Man­age­ment, Monashee In­vest­ment Man­age­ment, High­side Cap­i­tal Man­age­ment, Pfiz­er Ven­tures, Mer­ck Glob­al Health In­no­va­tion Fund, Ar­bore­tum Ven­tures, Deer­field Man­age­ment, Baird Cap­i­tal and Re­nais­sance Ven­ture Cap­i­tal Fund. The new cash brings Stra­ta’s to­tal raise to over $130 mil­lion.

When asked if an IPO is on the hori­zon, Rhodes said it’s “ like­ly in the fu­ture for us,” though not­ed he has noth­ing de­fin­i­tive to an­nounce.

“We’re look­ing at sort of late ‘22 maybe ear­ly ‘23, but this round of fund­ing sort of car­ries us through to an IPO,” he said.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Af­ter sell­ing to Genen­tech, the old Je­cure team is back at an RNA-fo­cused start­up — and more en­thu­si­as­tic than ever

When Genentech swooped in to buy NASH-focused Jecure Therapeutics back in 2018, a handful of the startup’s executives weren’t quite ready to disperse.

It had been just three years since Jecure launched with a preclinical portfolio of NLRP3 inhibitors — and the takeover came sooner than anyone, including CEO Jeff Stafford, had expected. So he got talking with James Veal and Gretchen Bain, two serial entrepreneurs in charge of Jecure’s R&D.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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