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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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Philip Astley-Sparke, Replimune CEO

Replimune looks to rope in $225M on the back of melanoma da­ta

The Massachusetts-based, oncolytic virus biotech Replimune is feeling bullish now that it has lifted the cover on data for its lead product.

Replimune said Thursday it looks to nab about $225 million from a public offering after giving a snapshot of some initial data from its IGNYTE clinical study earlier this week. The trial is investigating RP1 in combination with Opdivo, for patients with melanoma and who did not have a response when being treated with a PD-1.