One of the biggest the­o­ries about the cause of ag­ing, and how to slow and po­ten­tial­ly even re­verse it, is about to be put to the test.

Life Bio­sciences, a biotech start­up co-found­ed by Har­vard bi­ol­o­gist David Sin­clair, got the FDA's per­mis­sion to be­gin a clin­i­cal study of its gene ther­a­py de­signed to rewind the clock on dy­ing cells, the start­up told End­points News in an ex­clu­sive in­ter­view.

The star­tup's ther­a­py has been a long time com­ing. In the late 1990s, Sin­clair pro­posed that ag­ing is pri­mar­i­ly due to the loss of epi­ge­net­ic in­for­ma­tion — the chem­i­cal marks that con­trol how DNA is turned on and off — which he dubbed the in­for­ma­tion the­o­ry of ag­ing. Life Bio’s ther­a­py de­liv­ers a trio of pro­teins that Sin­clair’s lab dis­cov­ered can re­set the epigenome to a more youth­ful state.

The FDA has al­lowed In­tel­lia Ther­a­peu­tics to re­sume one of its two piv­otal tri­als of a gene edit­ing ther­a­py for transthyretin amy­loi­do­sis, which is a dis­ease caused by mis­fold­ed pro­teins.

In­tel­lia re­port­ed Tues­day that the FDA lift­ed a clin­i­cal hold on MAG­NI­TUDE-2, which ex­am­ines the gene edit­ing ther­a­py known as nex-z in a man­i­fes­ta­tion of the dis­ease that dam­ages the nerves — transthyretin amy­loi­do­sis (AT­TR) with polyneu­ropa­thy. The clin­i­cal hold was put in place in Oc­to­ber af­ter a pa­tient who re­ceived the ex­per­i­men­tal treat­ment was hos­pi­tal­ized for liv­er in­jury and sub­se­quent­ly died.

The gene edit­ing com­pa­ny’s oth­er Phase 3 tri­al, which is for the heart man­i­fes­ta­tion of the dis­ease known as AT­TR with car­diomy­opa­thy, is still sus­pend­ed. The pa­tient who died was part of that tri­al, known as MAG­NI­TUDE.

Boehringer In­gel­heim will pair up with Sim­cere Phar­ma­ceu­ti­cal in one of the hottest tar­gets in im­munol­o­gy.

For €42 mil­lion ($50 mil­lion) up­front, the Ger­man phar­ma will tap in­to Sim­cere's pre­clin­i­cal TL1Ax­IL-23p19 bis­pe­cif­ic an­ti­body for in­flam­ma­to­ry bow­el dis­ease, Sim­cere said in a Hong Kong Stock Ex­change fil­ing on Tues­day. The as­set is co­de­named SIM0709.

Boehringer said in vi­vo an­i­mal stud­ies showed SIM0709 had "su­pe­ri­or syn­er­gis­tic ef­fi­ca­cy, even out­per­form­ing the com­bi­na­tion of the two cor­re­spond­ing monother­a­pies," re­fer­ring to block­ing of TL1A and IL-23.

TL1A be­came one of the most prized next-gen­er­a­tion tar­gets in IBD a few years ago, when Mer­ck and Roche both inked multi­bil­lion-dol­lar ac­qui­si­tions. Oth­er phar­ma com­pa­nies have fol­lowed.

Boehringer is on the hook for a to­tal biobucks pack­age of up to €1.016 bil­lion ($1.2 bil­lion) for ex-Chi­na rights to SIM0709.

In­sil­i­co Med­i­cine is hav­ing quite a month. Fresh from deals with Servi­er and Hyg­tia Ther­a­peu­tics, the biotech has signed a new col­lab­o­ra­tion with Shang­hai-based Qilu Phar­ma­ceu­ti­cal worth near­ly $120 mil­lion.

The pact will see the part­ners use In­sil­i­co’s Phar­ma.AI drug dis­cov­ery plat­form to de­vel­op small-mol­e­cule drugs for car­diometa­bol­ic dis­eases. The part­ners did not state ex­act­ly which con­di­tions they in­tend to look at.

In­sil­i­co will fo­cus on the de­sign and op­ti­miza­tion of the nov­el com­pounds, and Qilu will take over sub­se­quent de­vel­op­ment and sell any re­sult­ing drugs.

The deal pro­