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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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CEO Lex Rovner (64x Bio)

A George Church spin­out fight­ing the vi­ral vec­tor bot­tle­neck in cell and gene ther­a­py lands $55M

A synthetic biology company spun out of George Church’s lab is set to tackle the gene therapy manufacturing bottleneck, and it just landed $55 million in a Series A financing round to do so.

64x Bio comes out of the Harvard Department of Genetics. CEO Lex Rovner and her team — which right now, sits around 10 people — are looking to tackle a key hurdle for major companies: manufacturing cell and gene therapies.