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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Rep. Vern Buchanan (R-FL) (Bill Clark/CQ Roll Call via AP Images)

Af­ter cov­er­age re­stric­tions for Alzheimer's drugs, bi­par­ti­san House bill would force CMS to re­view drugs in­di­vid­u­al­ly

When Biogen’s controversial Alzheimer’s drug Aduhelm was hit with a national decision from CMS that restricted coverage to only randomized trials, practically guaranteeing a commercial flop in the near term, questions surfaced over why CMS also included all amyloid-targeted monoclonal antibodies for Alzheimer’s disease.

With Eisai and Biogen’s second Alzheimer’s drug, lecanemab, now showing it can slow the rate of cognitive decline versus placebo, lining up for a likely full approval next spring, the question now turns to whether that data, which is being presented at the Clinical Trials on Alzheimer’s Congress in San Francisco in late November, will be enough for CMS when it asks, “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”

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FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in 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 the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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Af­ter Covid set­back, Val­ne­va lines up $100M for Pfiz­er-al­lied Ly­me dis­ease PhI­II

Valneva has secured €102.9 million (around $99.9 million USD) in a share offering to push forward its Pfizer-partnered Lyme disease vaccine and a jab for chikungunya that awaits an FDA decision.

The French vaccine maker largely snagged the near $100 million from Deep Track Capital and local state-owned Bpifrance, the company said Tuesday night. The capital injection is nearly equal to the amount Pfizer paid to nab equity in the company earlier this summer as part of the duo’s vaccine tie-up.