Alif Saleh, Scipher Medicine CEO

Pre­ci­sion im­munol­o­gy play­er bags $110M to fund its work on 'dis­ease sig­na­ture' tests

A Mass­a­chu­setts start­up is walk­ing away from its lat­est fi­nanc­ing haul with over $100 mil­lion in fresh cash, thanks to an in­vestor syn­di­cate back­ing their pur­suit of pa­tient re­sponse tests.

The $110 mil­lion round for Sci­pher Med­i­cine was led by Cowen Health­care In­vest­ments, and in­cludes ex­ist­ing big-name back­ers North­pond Ven­tures and Khosla Ven­tures — bring­ing Sci­pher’s to­tal fundrais­ing to $227 mil­lion.

The au­toim­mune-fo­cused biotech, orig­i­nal­ly com­ing out of an aca­d­e­m­ic col­lab­o­ra­tion in 2015, touts a blood test re­leased in 2020 as its first phys­i­cal prod­uct. Sci­pher has been fo­cused on tak­ing datasets and iden­ti­fy­ing a pa­tient’s “dis­ease sig­na­ture” — which as CEO Alif Saleh told End­points News is a mea­sure of gene ex­pres­sion da­ta in whole blood.

That gene ex­pres­sion da­ta “ba­si­cal­ly tells you with our plat­form and our tech­nol­o­gy where the dis­ease bi­ol­o­gy sits,” Saleh said. “So we see us­ing gene ex­pres­sion da­ta where that bi­ol­o­gy sits, which then al­lows us to see if there’s a drug that tar­gets that par­tic­u­lar sig­na­ture, and if so, like­ly that the re­sponse is very high. If not, if the drug doesn’t tar­get the dis­ease sig­na­ture, then like­li­hood re­sponse is very low.”

There is al­so a sec­ond part to Sci­pher Med­i­cine: a pre­ci­sion med­i­cine da­ta busi­ness. As Saleh put it, test­ing gen­er­ates a lot of mol­e­c­u­lar and clin­i­cal da­ta, so they are build­ing a data­base of the da­ta they are col­lect­ing for au­toim­mune dis­eases, which they share through part­ner­ships with phar­ma­ceu­ti­cal com­pa­nies in the drug dis­cov­ery process.

The com­pa­ny an­nounced one such col­lab­o­ra­tion with Gala­pa­gos back in 2020 — with Sci­pher find­ing drug tar­gets for in­flam­ma­to­ry bow­el dis­ease us­ing its plat­form, and Gala­pa­gos hav­ing the op­tion to take those tar­gets in­to fur­ther de­vel­op­ment, clin­i­cals and com­mer­cial­iza­tion.

The aca­d­e­m­ic col­lab­o­ra­tion be­hind Sci­pher was helmed by co-founders Joe Loscal­zo and Al­bert-Las­z­lo Barabasi, who is a physi­cist at North­east­ern Uni­ver­si­ty. Loscal­zo, chair of the De­part­ment of Med­i­cine and physi­cian-in-chief at Brigham and Women’s Hos­pi­tal, had been work­ing for years on map­ping the “hu­man in­ter­ac­tome,” the set of pro­tein-on-pro­tein in­ter­ac­tions with­in hu­man cells.

And that map­ping project be­came the ba­sis for Sci­pher, de­vel­op­ing pre­dic­tive drug re­sponse tests.

Sci­pher’s cur­rent prod­uct, known as Prism­RA, looks at pa­tient re­sponse for specif­i­cal­ly an­ti-TNF drugs, and the biotech orig­i­nal­ly start­ed look­ing at that par­tic­u­lar drug class for rheuma­toid arthri­tis, like drug sales king Hu­mi­ra, Rem­i­cade and En­brel.

And akin to the fi­nanc­ing: The large check will fund the launch of more tests from Sci­pher’s pipeline at one new test a year for the next five years. The next one, sched­uled to re­lease some­time this year, is Pris­mUC for ul­cer­a­tive col­i­tis. The CEO al­so said that ad­di­tion­al tests for Crohn’s dis­ease and MS were in the works.

An IPO is in the cards for the di­ag­nos­tics com­pa­ny mov­ing for­ward, but with the way that the mar­kets are, the com­pa­ny is in no rush to get there.

“We will go when the mar­kets are ready, and we are ready,” Saleh said.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

Endpoints editor and founder John Carroll sat down the Catalent CEO Alessandro Maselli to talk about what’s ahead in 2023. Right or wrong, this covers all the big issues faced by biopharma. This transcript has been edited for brevity and clarity.

John Carroll:

I think 2022 had to be one of the worst years ever for crystal balls. You went into 2022 thinking all sorts of nice things about what was ahead, not thinking about a European land war, maybe not thinking that the Federal Reserve was going to be jacking up interest rates as fast as they could to get ahead of inflation. Just a tremendous number of macroeconomic issues that were out there. The sudden and complete collapse of support on the markets in Nasdaq for biotech. A lot of darlings in the industry that had been out there for a while suddenly found themselves moving from a really hot market to a really cold market all of a sudden and had to make a lot of different changes in terms of strategizing.

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

Al­to Neu­ro­science bags $25M for four Phase II drugs

Another $25 million is flowing the way of a California biotech attempting to fix the “trial and error” system in neuroscience drug R&D.

Alto Neuroscience picked up the capital from Alpha Wave Ventures via an extension to its Series B, bringing total equity raised to $100 million since the startup’s 2019 founding. The biotech also recently signed up for a $35 million credit facility.

All that capital will help the biotech investigate four drugs through four Phase II readouts, Alto said Monday morning. That means enough money to keep the lights on into 2025, a year longer than projected under the original Series B close.

Tyler Golato, VitaDAO co-initiator

Pfiz­er-backed de­cen­tral­ized co­op­er­a­tive rais­es $4.1M to fund longevi­ty re­search

Months after Pfizer Ventures put a decentralized cooperative on the map by announcing a $500,000 infusion into its mission of funding human longevity research, the group — VitaDAO — is tying the bow around a $4.1 million fundraising round.

As its name implies, VitaDAO calls itself a DAO, or decentralized autonomous organization. Like many other such groups, it aims to run on a relatively flat, global structure using contracts on blockchains and crypto-tied tokens in hopes of proving a new way to fund big ideas and bridge the valley of death for very early-stage research on anti-aging.