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

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

The EU is reportedly working toward a centralized procurement deal for smallpox vaccines to tackle the rising number of cases of monkeypox, according to sources who spoke to the Financial Times.

Andrea Ammon, director of Europe’s CDC, told the FT that the European Commission is “definitely looking at what can be done centrally” and central procurement is “one of the options that are looked at but of course countries are also” looking into bilateral avenues.

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.