Novartis enlists Molecular Partners on radioligand therapy discovery; Galera blames CRO error for PhIII failure — claims success after all

A set­back in Covid-19 didn’t stop No­var­tis from team­ing up with Mol­e­c­u­lar Part­ners again. And this time, they will be look­ing for ra­dio­phar­ma­ceu­ti­cals.

Hav­ing bet big on the field, No­var­tis now wants to test a dif­fer­ent way of build­ing these ther­a­pies — by con­ju­gat­ing ra­di­oli­gands with Mol­e­c­u­lar Part­ners’ an­ti­body mimet­ics.

DARPin, as the class of pro­teins is known, are ge­net­i­cal­ly en­gi­neered pro­teins that can tar­get spe­cif­ic anti­gens just like tra­di­tion­al an­ti­bod­ies but are much small­er. When ap­plied to ra­di­oli­gand ther­a­pies, it promis­es to de­liv­er can­cer-killing ra­di­a­tion pre­cise­ly to tu­mor cells (while spar­ing healthy ones).

The deal starts small with $20 mil­lion up­front, but biobucks add up to $550 mil­lion.

‘Ra­di­oli­gand ther­a­py is a trans­for­ma­tive plat­form for de­liv­er­ing ra­di­a­tion to tar­get cells, and DARPins are a unique modal­i­ty for specif­i­cal­ly tar­get­ing tu­mors,’ said Jay Brad­ner, pres­i­dent of the No­var­tis In­sti­tutes for Bio­Med­ical Re­search. ‘The mar­riage of these two tech­nolo­gies is de­signed to en­able us to tar­get ra­di­oli­gands di­rect­ly to tu­mor cells any­where in the body with the goal of im­prov­ing and ex­tend­ing pa­tients’ lives.’

Mol­e­c­u­lar Part­ners CEO Patrick Am­stutz sees the new al­liance — which adds to a stack of oth­er phar­ma col­lab­o­ra­tions — as an­oth­er il­lus­tra­tion of just how ver­sa­tile his plat­form is.

‘While DARPins can be de­signed to per­form any num­ber of bi­o­log­i­cal tasks, here we high­light some of their in­nate char­ac­ter­is­tics, in­clud­ing small size and high speci­fici­ty and affin­i­ty, which may of­fer an ad­van­tage to RLT’s which of­ten re­quire a high­ly spe­cif­ic de­liv­ery ve­hi­cle.’

Most re­cent­ly, No­var­tis made a bet on enso­vibep, a DARPin an­tivi­ral can­di­date, but the drug failed a fu­til­i­ty analy­sis in hos­pi­tal­ized Covid-19 pa­tients. — Am­ber Tong

Galera re­bounds af­ter find­ing sta­tis­ti­cal er­ror in da­ta — claims PhI­II suc­cess

Two months ago, Galera’s stock price took a mas­sive nose­dive — down from $7.80 to $2.25 over a week­end — af­ter the biotech an­nounced that its lead can­di­date ava­sopasem failed to meet its pri­ma­ry end­point in a Phase III study. That end­point test­ed if the drug sig­nif­i­cant­ly re­duced the in­ci­dence of SOM (se­vere oral mu­cosi­tis), a painful com­pli­ca­tion from chemo and ra­di­a­tion, in pa­tients with lo­cal­ly ad­vanced head and neck can­cer com­pared to place­bo.

But this morn­ing, the Malvern, PA biotech is walk­ing that as­ser­tion back — and plac­ing the blame square­ly on its CRO. In an an­nounce­ment this morn­ing, Galera said that the un­named CRO made an er­ror in a sta­tis­ti­cal analy­sis, and the biotech now says that the cor­rect­ed re­sults show that ava­sopasem did, in fact, achieve sta­tis­ti­cal sig­nif­i­cance on the study’s pri­ma­ry end­point of re­duc­tion in the in­ci­dence of SOM.

Un­der the old da­ta read­out, those in the treat­ment group saw a slight re­duc­tion, 54% com­pared to 64% in the place­bo group. How­ev­er, the pri­ma­ry end­point had failed to achieve sta­tis­ti­cal sig­nif­i­cance (p=0.113). Af­ter the er­ror was cor­rect­ed, sta­tis­ti­cal sig­nif­i­cance was achieved (p=0.0451).

Galera’s stock price has surged since the an­nounce­ment — ear­ly trades on $GRTX have shot share prices over 100% from $1.38 on Mon­day to over $3 just af­ter trad­ing be­gan.

‘We are grat­i­fied that the Phase 3 RO­MAN tri­al achieved sta­tis­ti­cal sig­nif­i­cance on the pri­ma­ry end­point af­ter the cor­rec­tion of the sta­tis­ti­cal pro­gram­ming er­ror,’ said Galera’s pres­i­dent and CEO Mel Sorensen.

What’s next for the biotech? Well, it plans to meet with the FDA some­time next year and see­ing if their Phase III tri­al and an­oth­er Phase IIb tri­al will sup­port an NDA sub­mis­sion. — Paul Schloess­er

Bio­gen, Ther­a­Panacea team up on neu­ro­science-fo­cused, ma­chine learn­ing/AI dig­i­tal health col­lab­o­ra­tion

Bio­gen and small French AI out­fit Ther­a­Panacea an­nounced this morn­ing that they are launch­ing a col­lab­o­ra­tion — to lever­age ma­chine learn­ing and AI analy­sis on the dig­i­tal health front on neu­ro­science.

Ac­cord­ing to the two com­pa­nies, the goal is to de­vel­op dig­i­tal health so­lu­tions for im­proved pa­tient care, ac­cel­er­ate drug de­vel­op­ment and fur­ther the un­der­stand­ing of the un­der­ly­ing patholo­gies of neu­ro­log­i­cal dis­eases. The com­pa­nies would use ma­chine learn­ing and AI to an­a­lyze med­ical imag­ing and oth­er da­ta sources in hopes of im­prov­ing un­der­stand­ing of cer­tain dis­eases — and even pos­si­bly al­low for more per­son­al­ized clin­i­cal tri­al de­sign, they said in a state­ment.

As part of the agree­ment, Bio­gen will in­vest up to $15 mil­lion — in ex­change for Ther­a­Panacea con­vert­ible debt. The agree­ment al­so pro­vides for up to ap­prox­i­mate­ly $41 mil­lion in mile­stone pay­ments, con­tin­gent up­on achiev­ing cer­tain un­named R&D mile­stones. In ad­di­tion, Bio­gen gains ex­clu­sive rights to Ther­a­Panacea’s tech­nol­o­gy in neu­ro­science.

For Ther­a­Panacea, it will in­vest in ex­pand­ing its ex­ist­ing op­er­a­tions and work­force in Eu­rope to meet its goals of this col­lab­o­ra­tion. — Paul Schloess­er

Bel­gian biotech Gala­pa­gos ex­er­cis­es op­tion to li­cense Poland-based Ryvu’s in­flam­ma­tion pro­gram

Gala­pa­gos has ex­er­cised its ex­clu­sive op­tion for Pol­ish biotech Ryvu Ther­a­peu­tics’ in­flam­ma­tion drug.

The two biotechs have been part­ners in a joint re­search col­lab­o­ra­tion an­nounced back in April 2020 — fo­cused on drug dis­cov­ery and de­vel­op­ing small mol­e­cules with in­flam­ma­tion tar­gets. Ryvu was re­spon­si­ble for the ear­ly drug dis­cov­ery; the col­lab­o­ra­tion was based on a new drug tar­get iden­ti­fied by Ryvu and was dri­ven by the joint ef­fort of sci­en­tif­ic teams from both com­pa­nies.

‘We are de­light­ed with the re­sults of our re­search col­lab­o­ra­tion with Gala­pa­gos to date,’ said Ryvu’s CBO Vat­nak Vat-Ho.

With Gala­pa­gos now hav­ing world­wide rights to the pro­gram, Re­vue will get an op­tion ex­er­cise fee, plus roy­al­ties and mile­stones. And just like their an­nounce­ment last year, that amount re­mains un­known. — Paul Schloess­er
https://endpts.com/novartis-enlists-molecular-partners-on-radioligand-therapy-discovery-galera-blames-cro-error-for-phiii-failure-claims-success-after-all/