Every­One Med­i­cines, the first biotech com­pa­ny formed to de­vel­op in­di­vid­u­al­ized ther­a­pies for ge­net­i­cal­ly unique dis­eases, will close, End­points News has learned.

The de­ci­sion to wind down op­er­a­tions came less than a week af­ter the FDA re­leased a high­ly an­tic­i­pat­ed doc­u­ment out­lin­ing a stream­lined path­way for the de­vel­op­ment and ap­proval of those types of be­spoke med­i­cines.

But the FDA’s draft pol­i­cy fell short of what Every­One Med­i­cines an­tic­i­pat­ed, ac­cord­ing to a per­son fa­mil­iar with the mat­ter, who was grant­ed anonymi­ty to speak freely. It didn’t go far enough to make the com­mer­cial­iza­tion of cus­tom drugs fea­si­ble in the US, and was more con­strained than a UK pi­lot, the per­son said.

Ther­a­vance Bio­phar­ma will wind down its en­tire R&D or­ga­ni­za­tion and lay off 50% of its over­all work­force af­ter an­oth­er Phase 3 fail for an ex­per­i­men­tal med­i­cine called am­prelox­e­tine.

The US-Irish drug­mak­er said Tues­day that am­prelox­e­tine flopped in a late-stage test in pa­tients with symp­to­matic neu­ro­genic or­tho­sta­t­ic hy­poten­sion due to mul­ti­ple sys­tem at­ro­phy. The drug failed a Phase 3 in 2021, lead­ing to a 75% work­force re­duc­tion at the time. It missed the mark in an­oth­er Phase 3 in 2022.

Now, with an­oth­er Phase 3 set­back, Ther­a­vance said it will end de­vel­op­ment of the in­ves­ti­ga­tion­al drug and let go its en­tire R&D or­ga­ni­za­tion as well as oth­er em­ploy­ees. The com­pa­ny had 97 work­ers at the end of 2024.

Boehringer In­gel­heim is giv­ing up on a Phase 2 MASH pro­gram us­ing an ex­per­i­men­tal can­cer drug that goes af­ter the CD47 path­way, one of on­col­o­gy’s most al­lur­ing and trou­ble­some ther­a­peu­tic ap­proach­es.

The can­di­date, an an­ti-SIR­Pα mon­o­clon­al an­ti­body called BI 770371, is de­signed to block the CD47 “don’t eat me” sig­nal that can­cer cells use to shield them­selves from the im­mune sys­tem. For years, drug­mak­ers have tried ways of drug­ging CD47, but have been thwart­ed by dis­ap­point­ing read­outs and safe­ty con­cerns.

In pa­tients with MASH, Boehringer and its part­ner OSE Im­munother­a­peu­tics had hoped the drug could help im­prove fi­bro­sis of the liv­er. But a Phase 2 tri­al “did not show ef­fi­ca­cy sup­port­ing fur­ther de­vel­op­ment in this in­di­ca­tion,” a Boehringer spokesper­son told End­points News. 

Plus, news about Aca­dia Phar­ma­ceu­ti­cals, Poplar Ther­a­peu­tics and An­ti­verse:

🅰️ RTW’s Pro­li­um gets $50M: The New York-based biotech Pro­li­um Bio­science has $50 mil­lion in Se­ries A funds from RTW In­vest­ments. The fund­ing was an­nounced 14 months af­ter Pro­li­um’s T cell en­gager deal with Chi­na-based Keymed Bio­sciences. That pact got Pro­li­um a CD20xCD3 bis­pe­cif­ic, re­brand­ed as PRO-203, that will en­ter Phase 1/2 in sys­temic scle­ro­sis next quar­ter. — Kyle LaHu­cik

🔬 COUR re­ports Phase 2a da­ta: One year in­to the study, the biotech said its can­di­date CNP-104 demon­strat­ed “durable clin­i­cal ef­fects” in pa­tients with a chron­ic liv­er au­toim­mune dis­ease called pri­ma­ry bil­iary cholan­gi­tis. The com­pa­ny