Mark Enyedy, ImmunoGen CEO

Im­muno­Gen touts a PhI­II come­back in ovar­i­an can­cer, eye­ing a 2022 ac­cel­er­at­ed ap­proval

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.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

UP­DAT­ED: FDA slams Eli Lil­ly's 'mis­lead­ing' In­sta­gram ad for its type 2 di­a­betes in­jec­tion

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.