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.

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”