When Im­muno­Gen’s lead an­ti­body-drug con­ju­gate flunked a Phase III study in ovar­i­an can­cer a cou­ple years ago, the com­pa­ny clung to hope that it would per­form bet­ter in a sub­group of pa­tients with high fo­late re­cep­tor al­pha (FRα) ex­pres­sion.

On Tues­day, re­searchers un­corked topline Phase III re­sults sug­gest­ing it was right — and in­vestors cheered on the news with a 40% boost to Im­muno­Gen’s stock price $IMGN. CEO Mark Enyedy says he’s go­ing af­ter an ac­cel­er­at­ed ap­proval and plans to file in the first quar­ter of 2022.

A to­tal of 106 plat­inum-re­sis­tant ovar­i­an can­cer pa­tients who had tak­en a me­di­an of three pri­or ther­a­pies — at least one of them be­ing Genen­tech’s Avastin — en­rolled in the SO­RAYA study. Im­muno­Gen’s drug, called mirve­tux­imab so­rav­tan­sine, shrank tu­mors in 32.4% of pa­tients at a me­di­an fol­low-up of 8.1 months. And five of those pa­tients achieved a com­plete re­sponse.

“Any CR is ground­break­ing,” co-prin­ci­pal in­ves­ti­ga­tor Rob Cole­man said in a call with in­vestors on Tues­day. “Re­mem­ber, these are pa­tients who have pro­gressed through our best ther­a­pies mul­ti­ple times, and they have ac­tu­al vis­i­ble tu­mor that went away.”

The me­di­an du­ra­tion of re­sponse was 5.9 months, with near­ly half of re­spon­ders con­tin­u­ing on the ther­a­py, ac­cord­ing to Im­muno­Gen — though the com­pa­ny ex­pects to have more da­ta on DOR at a med­ical con­fer­ence next quar­ter.

While Im­muno­Gen says mirve­tux­imab was well-tol­er­at­ed, 41% of pa­tients ex­pe­ri­enced blurred vi­sion re­lat­ed to the treat­ment (though on­ly 6% ex­pe­ri­enced cas­es Grade 3 or high­er). Ker­atopa­thy, a dis­ease of the cornea, oc­curred in 35% of pa­tients and 29% ex­pe­ri­enced nau­sea.

“Com­pared to oth­er tox­i­c­i­ties that we deal with, with oth­er types of ther­a­pies, this one is very straight­for­ward to deal with,” co-prin­ci­pal in­ves­ti­ga­tor Ur­su­la Mat­u­lo­nis said of the vi­sion prob­lems. “I’ve been work­ing with this drug for many years now, and we have a set group of oph­thal­mol­o­gists we re­fer pa­tients to, and pa­tients are giv­en lu­bri­cat­ing eye drops, steroid eye drops.”

The oc­u­lar tox­i­c­i­ties are re­versible, she said, adding they “re­al­ly did not re­sult in very many pa­tients drop­ping out of the study.”

Be­yond SO­RAYA, Im­muno­Gen ex­pects to read out topline da­ta from a con­fir­ma­to­ry study called MI­RA­SOL in the third quar­ter of 2022 in the hopes of win­ning a full ap­proval for mirve­tux­imab.

In an­ti­body-drug con­ju­gates, a can­cer-killing tox­in is at­tached to a spe­cif­ic an­ti­body us­ing a biodegrad­able link­er. Im­muno­Gen has been a long­time play­er in the ADC field, but a Phase III fail­ure for mirve­tux­imab back in 2019 sent shares spi­ral­ing.

Pa­tients in that tri­al, dubbed FOR­WARD I, were giv­en ei­ther mirve­tux­imab or the physi­cian’s choice of sin­gle-agent chemother­a­py. Al­though the over­all re­sponse rate was high­er for mirve­tux­imab than chemother­a­py, the drug did not in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival, which was the main goal. It al­so failed to sig­nif­i­cant­ly im­prove over­all sur­vival. Two months lat­er, the FDA bat­ted back an at­tempt at an ac­cel­er­at­ed ap­proval based on a sec­ondary end­point.

At the end of 2019, Im­muno­Gen an­nounced it was launch­ing SO­RAYA in pa­tients with high FRα ex­pres­sion, which it said could sup­port ac­cel­er­at­ed ap­proval of the drug.

Enyedy is al­ready prep­ping a com­mer­cial launch, which he says could take off next year if all goes well.

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.