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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.