Gilmore O'Neill, incoming Editas Medicine CEO

With Ed­i­tas' third CEO in as many years, ex­pect a new CMO and new de­vel­op­ment part­ners

Sarep­ta Ther­a­peu­tics CMO Gilmore O’Neill will take over as CEO and pres­i­dent of CRISPR biotech Ed­i­tas Med­i­cine on June 1.

But al­ready in the hours since be­ing an­nounced, O’Neill has been hear­ing from his net­work on who could po­ten­tial­ly be the new CMO at the gene edit­ing com­pa­ny he’s about to helm. Lisa Michaels was fired from the med­ical chief post in ear­ly Feb­ru­ary, with­out pub­lic ex­pla­na­tion, as part of a re­build­ing of the C-suite.

Hir­ing a new CMO will be one of O’Neill’s top pri­or­i­ties when he takes over the C-suite posts from ex­ec­u­tive chair Jim Mullen, who was in the post for the past 14 months, the two said in a joint in­ter­view with End­points News. The pair know each oth­er well and will have few kinks to work out in the tran­si­tion pe­ri­od be­cause of their pri­or time to­geth­er at Bio­gen in the aughts, where Mullen was CEO and O’Neill held var­i­ous VP and SVP posts.

“The com­pa­ny hasn’t been as crisp on ex­e­cu­tion as it just needs to be, should be, has to be,” Mullen said of the lead­er­ship tran­si­tion. Ed­i­tas’ shares $ED­IT were down about 5.5% Thurs­day morn­ing. As ex­ec­u­tive chair, he’ll spend more time on “in­vestor de­vel­op­ment, think­ing about some pol­i­cy de­vel­op­ment, look­ing over the hori­zon at the days when we may start to com­mer­cial­ize prod­ucts.”

Jim Mullen

Busi­ness de­vel­op­ment and cap­i­tal rais­ing will be ad­di­tion­al fo­cus­es on “day one,” O’Neill said. His pre­de­ces­sor said Ed­i­tas has “not been as ac­tive or as pro­duc­tive on the busi­ness de­vel­op­ment front” as it could have been. The biotech will look to shore up ex­per­tise via part­ner­ing on its en­gi­neered NK cell pro­grams be­cause of the space’s “uber com­pet­i­tive” and ex­pen­sive na­ture, Mullen said. In­bound in­ter­est is al­so flow­ing in from drug de­vel­op­ers look­ing to pair up their ther­a­peu­tics with Ed­i­tas’ edit­ing ma­chin­ery and tech, he added.

O’Neill was al­so look­ing for a new part­ner over the past few months. His job search was laser-fo­cused on CEO posts.

“Ed­i­tas jumped off the page at me just as an enor­mous­ly ex­cit­ing op­por­tu­ni­ty. Why? The tech­nol­o­gy. It has un­lim­it­ed, re­al­ly, po­ten­tial and then the com­pa­ny it­self there [is] dif­fer­en­ti­at­ed core ex­per­tise in the com­pa­ny around nu­cle­as­es en­hance­ments, around guide RNA chem­istry and de­sign, as well as ex­pe­ri­ences with dif­fer­ent de­liv­ery method­olo­gies,” O’Neill said.

He in­her­its a nine-year-old biotech found­ed with the po­ten­tial to be a pi­o­neer in the CRISPR field. The com­pa­ny was born out of the sci­ence from CRISPR and gene edit­ing lead­ers Feng Zhang, George Church, J. Kei­th Joung and David Liu.

But the com­pa­ny has had on­ly a few clin­i­cal tri­al da­ta re­leas­es since en­ter­ing hu­man stud­ies. The com­pa­ny pre­sent­ed some ini­tial da­ta on ED­IT-101 for Leber con­gen­i­tal amau­ro­sis, a rare ge­net­ic vi­sion-loss dis­or­der, in Oc­to­ber 2021. And this week, the biotech said it be­came the first to test a CRISPR gene edit­ing med in vi­vo in a pe­di­atric pa­tient with ED­IT-101. Ed­i­tas be­gan test­ing ED­IT-101 in Ju­ly 2019 with part­ner Al­ler­gan, but Ab­b­Vie ditched the deal in Au­gust 2020.

Al­so this year, Ed­i­tas will be­gin test­ing its sec­ond pro­gram, ED­IT-301, in pa­tients with sick­le cell dis­ease and in an­oth­er study in pa­tients with trans­fu­sion-de­pen­dent be­ta tha­lassemia.

O’Neill has been CMO and EVP of R&D at Sarep­ta since June 2018, where he’s con­tributed to the Cam­bridge, MA biotech’s gene ther­a­pies for Duchenne mus­cu­lar dy­s­tro­phy, Amondys and Vyondys. Ed­i­tas al­so tout­ed O’Neill’s work on Bio­gen’s spinal mus­cu­lar at­ro­phy drug Spin­raza and MS ther­a­pies Ple­gridy and Tec­fidera.

He’s the third new CEO since 2019. Mullen took over in Feb­ru­ary 2021, when Cyn­thia Collins de­part­ed fol­low­ing a two-year stint af­ter Ka­trine Bosley’s ex­it in Jan­u­ary 2019. Mul­ti­ple oth­er sci­ence and med­ical chiefs have packed up their bags in re­cent years, too.

“The first thing to start with on long-term vi­a­bil­i­ty is to have some­body that’s younger, which prob­a­bly doesn’t nec­es­sar­i­ly in­clude me,” Mullen jok­ing­ly said.

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In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

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But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

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Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

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In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

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