News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks af­ter join­ing Ve­rastem On­col­o­gy as chief med­ical of­fi­cer, Frank Neu­mann is leav­ing the com­pa­ny for an­oth­er job.

Neu­mann had joined Ve­rastem af­ter leav­ing blue­bird bio, which sur­pris­ing­ly split in­to two com­pa­nies last week, one in on­col­o­gy and one in rare dis­eases. It’s not yet clear to where Neu­mann is head­ed next, but he not­ed in a state­ment that Ve­rastem’s da­ta and strat­e­gy were “tru­ly ex­cit­ing.”

“This de­ci­sion to leave is dif­fi­cult and based sole­ly on con­tin­u­ing my work in cell ther­a­py,” Neu­mann said. “I am con­fi­dent that Ve­rastem will con­tin­ue to make a pos­i­tive im­pact on pa­tients’ lives.”

Be­fore his tenure at blue­bird, Neu­mann de­vot­ed five years to Take­da, lead­ing clin­i­cal de­vel­op­ment across their cell ther­a­py spec­trum in his fi­nal year there. He was Take­da’s glob­al clin­i­cal lead for pona­tinib and med­ical team lead for ix­a­zomib. — Max Gel­man

Ther­mo Fish­er inks $550M M&A deal for rapid test­ing com­pa­ny

Ther­mo Fish­er is shelling out $450 mil­lion in cash and promis­ing $100 mil­lion in mile­stones to snap up Mesa Biotech, a di­ag­nos­tics out­fit that makes rapid tests for in­fec­tious dis­eases — in­clud­ing Covid-19.

Mesa was one of the first com­pa­nies to roll out a quick test for SARS-CoV-2.

Mark Steven­son, ex­ec­u­tive VP and COO of Ther­mo Fish­er Sci­en­tif­ic, had this to say in a pre­pared state­ment:

”The ad­di­tion of Mesa Biotech’s easy-to-use, rapid PCR-based test is high­ly com­ple­men­tary to our ex­ist­ing of­fer­ing and will fur­ther help us meet the con­tin­u­ing de­mand for COVID-re­lat­ed test­ing while we work to rapid­ly scale and de­vel­op point-of care tests for oth­er in­fec­tious dis­eases in the fu­ture.” — John Car­roll

SCO­TUS de­clines to take up Mer­ck patent ap­peal for so­fos­bu­vir

Mer­ck’s fi­nal hope to re­vive a mas­sive dam­ages award has been quashed.

The Big Phar­ma had sought in­ter­ven­tion from the US Supreme Court to re­store a de­ci­sion that would have grant­ed the com­pa­ny more than $2.5 bil­lion in dam­ages re­lat­ed to a patent fight with Gilead. But the jus­tices de­clined to take up the case, leav­ing the low­er court’s rul­ing in place and Mer­ck with­out fur­ther re­course.

Tues­day’s de­ci­sion stems from a bat­tle over Gilead’s so­fos­bu­vir, which Mer­ck had claimed in­fringed on a patent held by Mer­ck sub­sidiary Idenix Phar­ma­ceu­ti­cals. A fed­er­al court ruled in fa­vor of Mer­ck in 2016 and or­dered Gilead to pay $2.54 bil­lion in penal­ties.

But a fed­er­al judge threw out the ver­dict in 2018, de­ter­min­ing that the patent in ques­tion was in­valid. The US Court of Ap­peals for the Fed­er­al Cir­cuit up­held that rul­ing the next year, giv­ing Mer­ck one last chance to ap­peal to the Supreme Court. Their ef­forts came up short Tues­day.

So­fos­bu­vir, sold as So­val­di in the US, is used in com­bi­na­tion with rib­avirin ei­ther with or with­out in­jectable pegin­ter­fer­on al­fa to treat chron­ic he­pati­tis C in­fec­tion in pa­tients old­er than 3. — Max Gel­man

As­traZeneca, Dai­ichi’s En­her­tu earns EU nod for HER2-pos­i­tive breast can­cer

A day af­ter earn­ing the FDA’s trust for its ap­pli­ca­tion in stom­ach can­cer, As­traZeneca and Dai­ichi Sankyo’s an­ti­body-drug con­ju­gate En­her­tu has snared an EU nod for metasta­t­ic breast can­cer.

The tar­get­ed pop­u­la­tion has been di­ag­nosed with tu­mors that ex­press the HER2 gene, En­her­tu’s spe­cial­ty. The EMA based its re­view on da­ta from the piv­otal Phase II DES­TINY-Breast01 tri­al, in which En­her­tu post­ed an ob­jec­tive re­sponse rate of 61.4% at the 20.5-month fol­lowup mark, in­clud­ing a 6.5% com­plete re­sponse rate and a 54.9% par­tial re­sponse rate.

The drug al­so in­duced an es­ti­mat­ed me­di­an du­ra­tion of re­sponse of 20.8 months in pa­tients who had re­ceived at least two pre­vi­ous lines of ther­a­py.

Ear­li­er this week, En­her­tu scored an FDA nod in gas­tric can­cer to match its ear­li­er ap­proval in breast can­cer. That ap­proval made it the first ADC with the go-ahead to treat ad­vanced stom­ach can­cer, a dif­fi­cult-to-treat dis­ease with a poor prog­no­sis. — Kyle Blanken­ship

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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Ab­b­Vie snaps up a bis­pe­cif­ic for mul­ti­ple myelo­ma in TeneoOne buy­out; Ver­tex launch­es $1.5B share buy­back pro­gram

Following a positive interim Phase I readout, AbbVie is exercising an option to acquire TeneoOne and its BCMA candidate TNB-383B for relapsed or refractory multiple myeloma.

AbbVie inked a deal with TeneoOne back in 2019 to develop and commercialize TNB-383B, a bispecific antibody that targets BCMA and CD3. The treatment is designed to direct the body’s immune system against BCMA-expressing tumor cells. And according to interim results, the candidate showed a 79% objective response rate in a Phase I study. Sixty-three percent of patients saw a “very good partial response” or better, and 29% saw a complete response at doses greater than or equal to 40 mg at a median follow-up of 6.1 months.

James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.