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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

Three­'s a crowd as an­oth­er Kite ex­ec hits the ex­it; Surf­ing tough wa­ters, Celyad On­col­o­gy picks up new CEO

Kite Pharma is losing another exec, as Francesco Marincola leaves his post to join Flagship startup Sonata Therapeutics as CSO. Marincola served as Kite’s SVP and global head of cell therapy research, having joined the company in 2021 after a stint as CSO at Refuge Biotechnologies. Marincola has also served as a distinguished research fellow at AbbVie and spent more than two decades at the NIH and NCI. Marincola’s exit from Kite marks the third, following CEO Christi Shaw and Tecartus global program clinical lead Behzad Kharabi, who both left last month.

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