Se­lec­ta turns to syn­bio play­er for $1.1B cap­sid deal; BioN­Tech signs $790M im­munother­a­py deal

Se­lec­ta Bio­sciences has turned to one of the re­cent dar­lings in the syn­bio biz for its lat­est col­lab­o­ra­tion.

Gink­go Bioworks has signed on to a biobucks-heavy deal to work on next-gen gene ther­a­py vi­ral cap­sids for Se­lec­ta, a hot top­ic in an in­dus­try that has iden­ti­fied a full slate of is­sues with the ear­ly-gen AAV ve­hi­cles that have dom­i­nat­ed the first-gen pro­grams. This is their sec­ond cap­sid-fo­cused col­lab­o­ra­tion.

Carsten Brunn, CEO of Se­lec­ta Bio­sciences, said:

By com­bin­ing Imm­TOR with next-gen­er­a­tion, fit-for-pur­pose AAV vec­tors, we hope to fur­ther im­prove the safe­ty and ef­fi­ca­cy of AAV me­di­at­ed gene ther­a­pies.

There are some un­spec­i­fied up­fronts in the deal pack­age, which tots up to $200 mil­lion per pro­gram and $1.1 bil­lion in to­tal, pro­vid­ed every­thing goes per­fect­ly.

Gink­go shares $DNA are down about 9% this morn­ing, and way off from their IPO price — the com­pa­ny went pub­lic in a $17.5 bil­lion SPAC deal —as the stock dived in re­cent months. — John Car­roll

BioN­Tech signs $790M I/O col­lab with Crescen­do

Like its mR­NA coun­ter­part, BioN­Tech is look­ing to ex­pand its for­tunes be­yond its wild­ly suc­cess­ful Covid-19 vac­cine. And on Mon­day, the com­pa­ny signed a new part­ner­ship to that ef­fect.

BioN­Tech will team up with Crescen­do Bi­o­log­ics to de­vel­op im­munother­a­pies for can­cers and oth­er dis­eases, the com­pa­nies an­nounced Mon­day. BioN­Tech will pay $40 mil­lion up­front and promise up to $750 mil­lion in mile­stones for mul­ti­ple pro­grams.

“Crescen­do’s plat­form pro­vides ex­cel­lent prop­er­ties for ex­ploit­ing nov­el tar­gets and tar­get com­bi­na­tions which we be­lieve has great po­ten­tial for the de­vel­op­ment of mul­ti-spe­cif­ic mR­NA and en­gi­neered cell-based ther­a­pies in a va­ri­ety of dis­ease ar­eas,” BioN­Tech CEO Ugur Sahin said in a state­ment.

Crescen­do has de­vel­oped a plat­form that aims to de­liv­er “ful­ly hu­man heavy-chain an­ti­body do­mains,” which BioN­Tech hopes can pair well with its mR­NA ca­pa­bil­i­ties.

It’s not the first big-name com­pa­ny with which Crescen­do has part­nered. Back in 2016, the biotech col­lab­o­rat­ed with Take­da in a near­ly $800 mil­lion deal, with $36 mil­lion up­front and $754 mil­lion in promised mile­stones if every con­di­tion had been met. — Max Gel­man

Am­gen’s Lumakras gets con­di­tion­al ap­proval in the EU

Lumakras has fi­nal­ly got­ten the thumbs up in the EU, un­der the name Lumykras.

More than sev­en months af­ter get­ting the land­mark seal of ap­proval in the US for pa­tients with KRAS-G12C mu­tat­ed NSCLC, Am­gen an­nounced this morn­ing that the Eu­ro­pean Com­mis­sion grant­ed Am­gen’s block­buster con­di­tion­al mar­ket­ing au­tho­riza­tion, re­serv­ing it for pa­tients both with the mu­ta­tion and who have had at least one pri­or line of sys­temic ther­a­py.

Ac­cord­ing to Am­gen, con­tin­ued ap­proval for Lumykras may be con­tin­gent up­on ver­i­fi­ca­tion and de­scrip­tion of clin­i­cal ben­e­fit in at least one con­fir­ma­to­ry tri­al.

The EC gave its okay af­ter the CHMP rec­om­mend­ed the drug’s ap­proval, cit­ing its re­view of da­ta from the Phase II CODE­BREAK100 study, which showed so­tora­sib post­ing a 37.1% over­all re­sponse rate among 126 pa­tients with ad­vanced NSCLC and the KRAS G12C mu­ta­tion.

With the drug ap­proved in the US and con­di­tion­al­ly in the EU, Am­gen has sub­mit­ted pend­ing au­tho­riza­tion re­quests in nu­mer­ous oth­er coun­tries, such as Aus­tralia, Is­rael and Sin­ga­pore. — Paul Schloess­er

Co­herus nabs Jun­shi’s TIG­IT drug in ex­pand­ed I/O pact 

As Co­herus and Jun­shi await word from the FDA on their part­nered PD-1, tori­pal­imab, the transpa­cif­ic bud­dies are start­ing a new project to­geth­er.

Co­herus, a Red­wood City, CA-based biosim­i­lar mak­er that has been dip­ping its toes in nov­el drug R&D, is ex­er­cis­ing its op­tion to li­cense JS006, Jun­shi’s TIG­IT-tar­get­ed an­ti­body. It will pay the Shang­hai com­pa­ny $35 mil­lion up­front and re­serve up to $255 mil­lion in mile­stones, on top of 18% roy­al­ty on net prod­uct rev­enue should the drug be ap­proved.

JS006 is be­ing test­ed in com­bi­na­tion with tori­pal­imab as part of a dose-es­ca­la­tion, dose-ex­pan­sion tri­al, they not­ed.

In fol­low­ing up a PD-1 pact with a deal around TIG­IT — one of the most promis­ing check­point tar­gets emerg­ing in the im­muno-on­col­o­gy space — Co­herus’ moves close­ly par­al­lel those of No­var­tis, which has now ob­tained both a PD-1 and a TIG­IT drug from BeiGene.

“Block­ade of the TIG­IT path­way may be a cru­cial un­der­ly­ing mech­a­nism for over­com­ing re­sis­tance to check­point in­hi­bi­tion. We be­lieve the dual im­muno-ther­a­py ap­proach of TIG­IT with PD-1 could en­hance PD-1 ef­fi­ca­cy and cre­ate a new stan­dard-of-care for mul­ti­ple tu­mor types,” said There­sa LaVallee, chief de­vel­op­ment of­fi­cer at Co­herus. — Am­ber Tong

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Ei­sai cut­ting 91 jobs af­ter out-li­cense deal; Mer­ck touts first-line Keytru­da re­sults in en­dome­tri­al can­cer

Eisai will eliminate 91 after it out-licensed a seizure drug.

An Eisai spokesperson told Endpoints News that the change-up is tied to Fycompa, a seizure treatment that Florida rare disease biotech Catalyst Pharmaceuticals agreed to pay $160 million to Eisai in exchange for commercial rights back in December. The job cuts were originally flagged in a New Jersey state WARN notice.

The spokesperson said that Catalyst indicated interest in retaining up to 40 employees who work on Fycompa. Those who qualify will have an opportunity to interview with Catalyst.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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