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

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.

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 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.