Agenus’ lead can­cer vac­cine flops, in­ves­ti­ga­tors read last rites over glioblas­toma PhII

Just days af­ter hand­ing over the reins on a big an­ti­body col­lab­o­ra­tion to In­cyte, Agenus is now slam­ming the brakes on its top can­cer vac­cine tri­al, con­ced­ing a flop.

The Lex­ing­ton, MA-based biotech $AGEN says an in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee over­see­ing the Phase II com­bi­na­tion study of its can­cer vac­cine Prophage with Avastin (be­va­cizum­ab) found no en­cour­age­ment that the vac­cine — made of heat shock pro­tein-pep­tide com­plex­es tak­en from a pa­tient’s tu­mor tis­sue — was any bet­ter than be­va­cizum­ab alone in pro­long­ing sur­vival among brain can­cer pa­tients.

The study was launched in 2013 and in­tend­ed to re­cruit 165 pa­tients. Agenus qui­et­ly not­ed the fail­ure in a fil­ing with the SEC on Tues­day.

The bot­tom line in the 8-K:

The in­ter­im analy­sis sug­gest­ed that the tri­al is un­like­ly to demon­strate that the vac­cine in com­bi­na­tion with be­va­cizum­ab will lead to a bet­ter sur­vival than be­va­cizum­ab as a monother­a­py. There­fore, up­on the DSMB’s rec­om­men­da­tion, the ac­cru­al for the tri­al has been closed.

The biotech’s shares were down 5.5% in pre­mar­ket trad­ing Wednes­day.

A spokesper­son for the biotech says that while that Phase II has been closed, the pro­gram for Prophage is def­i­nite­ly con­tin­u­ing. Just a few weeks ago Agenus an­nounced plans to com­bine Prophage and the PD-1 drug Keytru­da in a new tri­al. The failed study was in late-stage pa­tients and this next study will be for new­ly di­ag­nosed glioblas­toma pa­tients.

“The ra­tio­nale for syn­er­gy be­tween Prophage and a check­point in­hibitor is much greater,” she adds. “This, along with ear­li­er stage pa­tients be­ing stud­ied in the tri­al, leads to ex­pec­ta­tions of bet­ter out­comes.”

Like a long line­up of can­cer vac­cines in re­cent years, Agenus’ at­tempt to kick­start an im­mune sys­tem at­tack ap­peared safe but in­ef­fec­tive in the most re­cent set­back, too weak to make a sig­nif­i­cant dif­fer­ence. The biotech al­so has a slate of check­points in the clin­ic, look­ing to fol­low up on a new ap­proach to re­mov­ing can­cer cells’ nat­ur­al de­fens­es so that they can be elim­i­nat­ed by the im­mune sys­tem.

A few days ago Agenus backed away from a 50/50 deal split arrange­ment that it had with In­cyte on an­ti­body de­vel­op­ment, trig­ger­ing some spec­u­la­tion that the com­pa­ny was too weak fi­nan­cial­ly to keep up its end of the bar­gain. Agenus set­tled for an $80 mil­lion cash in­fu­sion and a roy­al­ty stream on any prod­ucts that hit the mar­ket.

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Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

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Cynthia Butitta (L) and Joe Jimenez

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Joe Wiley, Amryt CEO

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Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

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