So here’s how Black­stone is spend­ing its $4.6 bil­lion bio­phar­ma pot.

The pri­vate eq­ui­ty firm an­nounced Tues­day they were team­ing with the CRISPR biotech In­tel­lia and the lit­tle-known Ger­man CAR-T start­up GEMoaB to launch a new — and so far un­named — CAR-T com­pa­ny. Black­stone, the sole in­vestor, will pour $250 mil­lion in­to the joint ven­ture and take a third own­er­ship. In­tel­lia and Cellex, GEMoaB’s par­ent com­pa­ny, will each take an­oth­er third.

The com­pa­ny will fo­cus on build­ing off-the-shelf CAR-Ts that can be ma­nip­u­lat­ed and con­trolled even af­ter they’re ad­min­is­tered to pa­tients — two of the ma­jor goals that oth­er CRISPR and cell ther­a­py com­pa­nies are now try­ing to at­tain.

“This launch rep­re­sents the first of many steps to ad­dress­ing the var­i­ous lim­i­ta­tions that cur­rent­ly ex­ist in the cell ther­a­py space,” In­tel­lia COO An­drew Schier­meier, who will be­come pres­i­dent and CEO of the new com­pa­ny, said in a state­ment.

Olivi­er Brandi­court

Olivi­er Brandi­court, the for­mer Sanofi CEO who joined Black­stone as an ad­vi­sor this year, will chair the board.

The new com­pa­ny will start out with two pro­grams al­ready in the clin­ic. A sub­sidiary of Cellex, GEMoaB al­ready put two con­trol­lable CAR-Ts in Phase I: one for leukemia and one for prostate can­cer.

Both pro­grams re­ly on GEMoaB’s con­trol­lable CAR-T tech­nol­o­gy. In­stead of arm­ing T cells with re­cep­tors that bind to pro­teins on can­cer cells, they put on re­cep­tors that bind to a “tar­get­ing mod­ule.” When the mod­ules are in­fused in­to a pa­tient, they bind to a pro­tein on can­cer cells and the CAR-Ts bind to the mod­ules. They then, hope­ful­ly, de­stroy the can­cer cells. If the mod­ules are ever tak­en away, GemOAB says — for ex­am­ple, be­cause the pa­tients are start­ing to show ma­jor side ef­fects — the CAR-Ts stop work­ing with­in four hours.

The ap­proach, they say, al­lows them to go af­ter tar­gets that would prove tox­ic un­der tra­di­tion­al CAR-T ap­proach­es. That in­cludes CD123, a promis­ing leukemia tar­get that oth­er de­vel­op­ers avoid­ed be­cause it al­so sits on healthy cells. Carl June’s Tmu­ni­ty Ther­a­peu­tics saw two deaths last month go­ing af­ter the same tar­get, PS­MA, that GEMoaB is pur­su­ing in can­cer.

It’s a sim­i­lar ap­proach to the one Ar­cel­lx is now pur­su­ing pre­clin­i­cal­ly and the one now-de­funct Unum pur­sued dis­as­trous­ly be­fore its col­lapse. But GEMoaB dis­tin­guished it­self with proof-of-con­cept hu­man da­ta at ASH last month.

Those pro­grams both re­ly on a pa­tients’ own cells, but the new com­pa­ny will al­so look to de­vel­op off-the-shelf ther­a­pies. There are few de­tails yet for the rest of the com­pa­ny’s ap­proach, ex­cept that it could al­so cov­er au­toim­mune dis­eases as well as can­cer. The new com­pa­ny will co-de­vel­op a CAR-T for can­cer with In­tel­lia and has an op­tion to co-de­vel­op a sec­ond one for a dif­fer­ent in­di­ca­tion.

In­tel­lia has been large­ly tight-lipped around its can­cer pipeline so far, dis­clos­ing on­ly one of sev­er­al ther­a­pies they’re de­vel­op­ing. But the deal comes at a time when more CRISPR com­pa­nies are push­ing in­to CAR-T. Large­ly, they’ve used CRISPR to en­gi­neer cells that can per­sist longer or that can be giv­en off-the-shelf.

Af­ter mak­ing progress on their sick­le cell ther­a­pies, CRISPR Ther­a­peu­tics’ next ma­jor batch of da­ta will come from a pair of can­cer cell ther­a­pies. In March, Cari­bou Bio­sciences raised $115 mil­lion as they pushed to de­vel­op CAR-Ts for the first time.

For Black­stone, the deal rep­re­sents one of their largest in­vest­ments in a start­up since they closed their $4.6 bil­lion fund last year, al­though they do not have a per­fect score­card on their pre­vi­ous bets. Fer­ring, a gene ther­a­py de­vel­op­er they gave $400 mil­lion, im­plod­ed this year.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Bristol Myers Squibb is upping the ante on its neurodegeneration partnership with German biotech Evotec. The Big Pharma will dole out $50 million upfront to expand the seven-year collaboration by another eight years.

Originally inked with Celgene, the partnership will now balloon to a potential $4 billion as the partners look at precision medicines across a variety of modalities. The first program in-licensed by BMS, EVT8683 for $20 million in 2021, is a small molecule in a Phase I study. Low double-digit tiered royalties are also on the table.