Roy Smythe, SomaLogic CEO

It's a brave new world for So­ma­Log­ic, as the pro­teomics biotech rides Eli Cas­d­in's newest SPAC to Nas­daq with $1.2B val­u­a­tion

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The bur­geon­ing field of pro­teomics has court­ed heavy in­vest­ment over the last few years, and on Mon­day a promi­nent pro­teomics biotech scored a new heap­ing of cap­i­tal.

So­ma­Log­ic an­nounced plans to re­verse-merge with Eli Cas­din and Kei­th Meis­ter’s sec­ond SPAC on Mon­day, dubbed CM Life Sci­ences II, fetch­ing the com­pa­ny a $1.23 bil­lion val­u­a­tion. The deal gives So­ma­Log­ic a cash in­fu­sion of $276 mil­lion from the SPAC’s IPO last month, as well as a pri­vate in­vest­ment of $375 mil­lion from a syn­di­cate of new and re­turn­ing in­vestors.

Once the merg­er clos­es some­time in the third quar­ter, the com­bined com­pa­ny will trade on the tick­er $SLGC.

Cas­din and Meis­ter had teamed up last sum­mer for their first blank check com­pa­ny, rais­ing what was then a mas­sive $385 mil­lion be­fore the SPAC flood­gates opened this year. Meis­ter, who is him­self a Carl Ic­ahn pro­tégé once viewed as the bil­lion­aire’s right-hand man, launched the SPAC in Au­gust 2020 and teamed up with Cas­din and his bio­phar­ma team.

The cash to­tal swelled to $443 mil­lion when the shell com­pa­ny an­nounced its in­tent to merge with Se­ma4 in Feb­ru­ary, giv­ing the J&J and Sanofi-part­nered pa­tient da­ta, test­ing and ge­nomics plat­form a $2 bil­lion val­u­a­tion. It was one of the largest life sci­ences SPAC deals to date as cash con­tin­ues to flow al­most un­fet­tered in­to SPACs.

Now the duo is back at it again with Mon­day’s So­ma­Log­ic agree­ment, bring­ing the Boul­der, CO-based biotech to Nas­daq. It’s one of a num­ber of biotechs look­ing to un­der­stand the hu­man body by look­ing at pro­teins, rather than DNA and RNA, and the deal comes just three months af­ter the com­pa­ny’s Se­ries A ex­ten­sion.

So­ma­Log­ic CEO Roy Smythe told End­points News that the “con­text” of the mar­ket helped fu­el their de­ci­sion to go pub­lic short­ly af­ter last year’s fundraise.

“We in­tend­ed on some time­line af­ter that Se­ries A to con­tem­plate a pub­lic tran­si­tion to think about when to do that,” Smythe told End­points. “We had been talk­ing about mak­ing a de­ci­sion pri­or to this, and the SPAC has some ad­van­tages de­pend­ing on your per­spec­tive as a com­pa­ny.”

With the merg­er, So­ma­Log­ic can now “dou­ble down” on its strat­e­gy of both col­lect­ing pro­teom­ic da­ta and cre­at­ing ap­pli­ca­tions for clin­i­cal tri­als us­ing that da­ta, Smythe added. The com­pa­ny says it has a to­tal of 20 val­i­dat­ed test­ing tools, known as So­maSig­nal, with an­oth­er 100 or so in de­vel­op­ment.

SPACs have trig­gered what’s be­come a gold rush on Wall Street, with more than $170 bil­lion poured in­to the hold­ing com­pa­nies so far this year. That’s al­ready eclipsed the fig­ure from all of 2020, Reuters re­port­ed last week, which hit $157 bil­lion.

That rush has on­ly brought in more mon­ey with a myr­i­ad of in­vestors try­ing to cap­i­tal­ize. There was the high-pro­file Richard Bran­son SPAC that merged with 23andMe in Feb­ru­ary, and Fore­site and Per­cep­tive, among oth­ers, have launched new blank check com­pa­nies in re­cent months.

The So­ma­Log­ic merg­er al­so comes short­ly af­ter the SEC opened an in­quiry in­to how Wall Street banks are man­ag­ing their risks in the blank check deals, ask­ing fi­nan­cial in­sti­tu­tions to vol­un­tar­i­ly pro­vide in­for­ma­tion about how they’re in­ter­nal­ly polic­ing SPACs.

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.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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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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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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