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.

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

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.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

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.”

Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

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.

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

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