Idera Pharmaceuticals’ stock tanks after AbbVie cuts enrollment early in a PhIb trial

When Idera Phar­ma­ceu­ti­cals flunked a Phase III melanoma tri­al with its Toll-like re­cep­tor 9 ag­o­nist tilso­tolimod back in March, ex­ec­u­tives clung to the hope that sep­a­rate tri­als in oth­er can­cers would turn up bet­ter re­sults.

With­out the re­sults it was hop­ing for, Idera says it’s now dis­con­tin­u­ing en­roll­ment in a key Phase II study and con­sid­er­ing out-li­cens­ing the can­di­date. Ab­b­Vie’s al­so cut­ting re­cruit­ment short in an ear­li­er-stage part­nered study — caus­ing Idera’s stock $IDRA, al­ready worth less than a $1, to tank more than 27% on Wednes­day af­ter­noon.

‘While our clin­i­cal tri­als with tilso­tolimod have not yet trans­lat­ed in­to a new treat­ment al­ter­na­tive for pa­tients, da­ta sup­port­ing tilso­tolimod’s mech­a­nism of ac­tion and en­cour­ag­ing safe­ty pro­file from across the ar­ray of pre-clin­i­cal and clin­i­cal work to date, to­geth­er with its in­tel­lec­tu­al prop­er­ty pro­tec­tion, are note­wor­thy,’ CEO Vin­cent Mi­lano said in a state­ment.

‘As a re­sult, we will con­sid­er an out-li­cens­ing arrange­ment for tilso­tolimod so that its full po­ten­tial may con­tin­ue to be ex­plored on be­half of pa­tients who do not re­spond to tra­di­tion­al im­munother­a­py,’ he added.

The first set of bad news on Wednes­day came from the sec­ond 10 pa­tients in the safe­ty co­hort of IL­LU­MI­NATE-206, a Phase II tri­al test­ing tilso­tolimod in com­bi­na­tion with Bris­tol My­ers Squibb’s Op­di­vo and Yer­voy in mi­crosatel­lite-sta­ble col­orec­tal can­cer. Of eight pa­tients who had a post-base­line dis­ease as­sess­ment, on­ly one saw sta­ble dis­ease, and the rest saw pro­gres­sion of their can­cer, Idera said. How­ev­er, that in­cludes one pa­tient who ex­pe­ri­enced a pseu­do-pro­gres­sion, mean­ing that the ini­tial in­crease from base­line in tu­mor bur­den was fol­lowed by a de­crease, which is con­sid­ered an im­mune-re­lat­ed par­tial re­sponse on an­oth­er scale.

Idera says it won’t en­roll any more pa­tients in IL­LU­MI­NATE-206. Ac­cord­ing to clin­i­cal tri­als.gov, the study was sup­posed to en­roll 30 pa­tients to­tal.

En­roll­ment is al­so be­ing dis­con­tin­ued in an Ab­b­Vie-spon­sored tri­al for re­cur­rent or metasta­t­ic head and neck squa­mous cell car­ci­no­ma, look­ing at tilso­tolimod in sev­er­al com­bi­na­tions with Ab­b­Vie can­di­dates.

The Phase Ib study, which was an­nounced back in 2019, was test­ing three sep­a­rate arms: An OX40 ag­o­nist called AB­BV-368 plus tilso­tolimod; AB­BV-368 plus tilso­tolimod and chemother­a­py (nab-pa­cli­tax­el); and AB­BV-368 plus tilso­tolimod, nab-pa­cli­tax­el and a PD-1 an­tag­o­nist called AB­BV-181.

Idera says the dis­con­tin­u­a­tion ‘was not re­lat­ed to safe­ty con­cerns,’ and that cur­rent treat­ment and fol­low-up is on­go­ing. Ab­b­Vie wasn’t avail­able for com­ment as of press time.

This isn’t the first time a Big Phar­ma part­ner­ship with tilso­tolimod didn’t work out. Back in May, Bris­tol My­ers Squibb said it wouldn’t fin­ish a tri­al as­sess­ing tilso­tolimod in com­bi­na­tion with ip­il­i­mum­ab ver­sus ip­il­i­mum­ab alone in pa­tients with an­ti-PD-1 re­frac­to­ry ad­vanced melanoma.

‘Our con­clu­sion is that the to­tal­i­ty of the da­ta, with all pa­tients hav­ing com­plet­ed the study treat­ment, does not sup­port the like­li­hood that the com­bi­na­tion of tilso­tolimod with ip­il­i­mum­ab would achieve a sta­tis­ti­cal­ly sig­nif­i­cant OS ben­e­fit over ip­il­i­mum­ab alone,’ Mi­lano said in a state­ment at the time.

Ac­cord­ing to Idera’s web­site, it ap­pears that tilso­tolimod is the on­ly can­di­date in the com­pa­ny’s pipeline.

The com­pa­ny says there are still two in­ves­ti­ga­tor-spon­sored stud­ies of tilso­tolimod on­go­ing at the VU Uni­ver­si­ty Med­ical Cen­ter (VUmc) Am­s­ter­dam and the Gus­tave Roussy Can­cer Cam­pus in Paris, as a monother­a­py in melanoma and a com­bi­na­tion ther­a­py with Op­di­vo and Yer­voy in ad­vanced can­cers, re­spec­tive­ly.

‘We al­so con­tin­ue both to pre­serve cash and to iden­ti­fy and ex­plore po­ten­tial de­vel­op­ment or com­mer­cial-stage as­sets for Idera’s port­fo­lio, and we are en­cour­aged by the op­por­tu­ni­ties pre­sent­ed to us,’ Mi­lano said.
https://endpts.com/idera-pharmaceuticals-stock-tanks-after-abbvie-cuts-enrollment-early-in-a-phib-trial/