At­las-backed Dyne taps Joshua Brumm as CEO; Sekar Kathire­san woos car­di­ol­o­gist to gene edit­ing start­up

Ro­mesh Sub­ra­man­ian’s new biotech start­up, Dyne Ther­a­peu­tics, which is us­ing oligonu­cleotides to de­grade RNA re­spon­si­ble for dis­ease has brought on Joshua Brumm as pres­i­dent and CEO. Sub­ra­man­ian will now take on the CSO role af­ter launch­ing the biotech as en­tre­pre­neur-in-res­i­dence at At­las Ven­ture. Brumm makes the leap af­ter a stint as COO and CFO of Kalei­do Bio­sciences, where he led the com­pa­ny’s IPO and helped bring its lead pro­gram in­to Phase II de­vel­op­ment. Pri­or to Kalei­do, Brumm was the COO and CFO at Ver­sar­tis. His oth­er pre­vi­ous roles span Phar­ma­cyclics, ZEL­TIQ Aes­thet­ics, Pro­te­olix, Cit­i­group Glob­al Mar­kets and Mor­gan Stan­ley

Sekar Kathire­san has wooed a vet­er­an car­di­ol­o­gist and sea­soned biotech en­tre­pre­neur to his mis­sion to pro­tect the world from heart dis­ease via gene edit­ing. An­drew Bellinger is the new CSO at Verve Ther­a­peu­tics, tak­ing up the same role he oc­cu­pied at Lyn­dra, a biotech he co-found­ed based on drug de­liv­ery tech in­vent­ed by Bob Langer. He will now di­rect the re­search and trans­la­tion­al skills ac­crued there (and Co­coon Biotech be­fore that) to safe­ly ed­it genes to low­er the risk of coro­nary artery dis­ease.

“In my car­di­ol­o­gy prac­tice, I’ve seen first­hand the lim­i­ta­tions of our present-day ap­proach to car­dio­vas­cu­lar dis­ease,” Bellinger, who sees pa­tients at Brigham and Women’s Hos­pi­tal, said in a state­ment. “With Verve, we have a pro­found op­por­tu­ni­ty to change the dy­nam­ic of health­care de­liv­ery for peo­ple liv­ing with or at risk for coro­nary artery dis­ease — con­fer­ring life­long re­sis­tance with a gene-edit­ing treat­ment giv­en once in life.”

Jnana Ther­a­peu­tics has brought on Al­ny­lam vet Car­o­line Stark Beer as CBO in search of new part­ners for its SLC trans­porter tech, which has spawned treat­ments for in­flam­ma­to­ry and neu­ro­log­i­cal dis­eases. Dur­ing her time at Al­ny­lam, Stark Beer served in a va­ri­ety of po­si­tions, in­clud­ing vice pres­i­dent and head of busi­ness de­vel­op­ment — where she helped fa­cil­i­tate part­ner­ships and li­cens­ing deals with Sanofi Gen­zyme and Re­gen­eron. Pri­or to her time at Al­ny­lam, Stark Beer held roles at Am­i­cus Ther­a­peu­tics and Bain & Com­pa­ny.

→ Fol­low­ing re­cent big changes at Vor Bio­phar­ma — the ap­point­ment of Robert Ang as CEO, the com­pa­ny’s re­cent move in­to an in­te­grat­ed head­quar­ters in Cam­bridge, MA and a $42 mil­lion Se­ries A round — the biotech has en­list­ed two more cell ther­a­py ex­perts to the team. Sadik Kas­sim and Tirtha Chakraborty have been named chief tech­nol­o­gy of­fi­cer and VP of re­search, re­spec­tive­ly. Kas­sim joins the com­pa­ny af­ter a stint as ex­ec­u­tive di­rec­tor at Kite Phar­ma and pre­vi­ous roles at Mus­tang Bio, No­var­tis (where he con­tributed to the BLA and MAA fil­ings for Kym­ri­ah), the Na­tion­al Can­cer In­sti­tute and Janssen. Chakraborty joins the com­pa­ny from Sana Biotech­nol­o­gy, where he served as VP of cell ther­a­py re­search. Pri­or to his time at Sana, Chakraborty was the head of hema­tol­ogy at CRISPR Ther­a­peu­tics and served a stint at Mod­er­na Ther­a­peu­tics

Sang­amo has se­lect­ed Bet­ti­na Cock­roft as the com­pa­ny’s SVP and CMO. Cock­roft draws from ex­pe­ri­ence from her time at Cy­tokinec­tics, where she was re­spon­si­ble for the clin­i­cal de­vel­op­ment of fast skele­tal mus­cle tro­ponin ac­ti­va­tors in dis­eases such as amy­otroph­ic lat­er­al scle­ro­sis and spinal mus­cu­lar at­ro­phy. In her new role, Cock­roft will shift fo­cus to gene-edit­ing pro­grams, in­clud­ing one for he­mo­phil­ia A part­nered with Pfiz­er. In ad­di­tion, Cock­roft has served as CMO of Au­ris Med­ical and pre­vi­ous­ly worked at Mer­ck Serono, No­var­tis Con­sumer Health and Menar­i­ni Ricerche

As­cle­tis Phar­ma — a com­pa­ny that paved the way in de­vel­op­ing and com­mer­cial­iz­ing Chi­na’s first home-cul­ti­vat­ed he­pati­tis C drug — has an­nounced that its CFO Lin­di Tan is de­part­ing. Tan’s de­par­ture comes weeks af­ter the Hangzhou-based biotech lost Zhengqing Li, a for­mer top Mer­ck ex­ec who jumped to the com­pa­ny as its CMO and pres­i­dent of R&D just months pri­or to help ex­tend its glob­al reach.

→ Sev­en years in­to a tu­mul­tuous tenure at Te­va — in which he was charged with down­siz­ing and clos­ing out man­u­fac­tur­ing op­er­a­tions while the com­pa­ny faced a probe in­to gener­ic drug price hikes in the US — Car­lo de No­taris­te­fani, EVP of glob­al op­er­a­tions, is step­ping down to re­tire.  Er­ic Drapé has been cho­sen as his suc­ces­sor and will be based out of the com­pa­ny’s glob­al head­quar­ters in Is­rael. Drapé joined the com­pa­ny in 2014 and has since served var­i­ous roles, in­clud­ing as EVP and chief qual­i­ty of­fi­cer and SVP, tech­ni­cal op­er­a­tions ster­iles, res­pi­ra­to­ry and bi­o­log­ics. No­taris­te­gani’s ex­it comes in the wake of two oth­er top ex­ec ex­its — CFO Michael Mc­Clel­lan and EVP glob­al brand and com­mu­ni­ca­tions Iris Beck-Cod­ner.

→ Af­ter it was an­nounced last week, in a sur­prise twist, that Akcea pres­i­dent Sarah Boyce along with her two top ex­ec col­leagues, CEO Paula Soteropou­los and COO Jef­frey Gold­berg were leav­ing the Io­n­is spin­off, Boyce has found a new home at Avid­i­ty Bio­sciences. The com­pa­ny is work­ing on an­ti­body-oligonu­cleotide con­ju­gates (AOCs), and as their new CEO Boyce will draw from ex­pe­ri­ence from her pre­vi­ous stints at Io­n­is, For­est Lab­o­ra­to­ries, Alex­ion Phar­ma­ceu­ti­cals, No­var­tis On­col­o­gy, and Roche.

→ Back in Ju­ly, AM-Phar­ma raised $113 mil­lion from a Eu­ro­pean syn­di­cate to help fund its planned Phase III tri­al in pa­tients with sep­sis-as­so­ci­at­ed acute kid­ney in­jury. Now the com­pa­ny is ex­pand­ing its lead­er­ship team with the ap­point­ments of Ju­liane Bern­holz as COO and Kristie Bass as VP clin­i­cal op­er­a­tions. Bern­holz will draw up­on ex­pe­ri­ence from her roles at Janssen, Sanofi, No­var­tis and Acte­lion. Bass tran­si­tions to her new po­si­tion af­ter serv­ing as se­nior di­rec­tor of project de­liv­ery at CRO PRA Health Sci­ences and di­rec­tor, project man­ag­er at PPD. Both Bern­holz and Bass will move from the US to the Nether­lands.

Neu­ro­crine Bio­sciences — which, back in Jan­u­ary, struck up a $1.8 bil­lion gene ther­a­py pact with Voy­ager Ther­a­peu­tics to snag the rights of four of their gene ther­a­py pro­grams — has wel­comed David Boy­er aboard as chief cor­po­rate af­fairs of­fi­cer. Boy­er makes the jump af­ter a stint at BGR Group as prin­ci­pal and head of the health & life sci­ences prac­tice. Pri­or to his role at BGR, Boy­er served as spe­cial as­sis­tant to the pres­i­dent for leg­isla­tive af­fairs un­der Pres­i­dent George W Bush, as­sis­tant com­mis­sion­er for leg­is­la­tion at the FDA and spe­cial as­sis­tant to the sec­re­tary at the US De­part­ment of Health and Hu­man Ser­vices. He’s al­so held po­si­tions at BIO and PhRMA.

→ Months af­ter strik­ing a re­verse merg­er deal with strug­gling His­to­gen­ics, Malvern, PA-based Ocu­gen has ap­point­ed San­jay Sub­ra­man­ian to the role of CFO. Sub­ra­man­ian joins the rare eye dis­ease-fo­cused biotech from the same po­si­tion at Ar­alez Phar­ma­ceu­ti­cals, where he helped the com­pa­ny close $350 mil­lion in fi­nanc­ing. Pri­or to his stint at Ar­alez, Sub­ra­man­ian held po­si­tions at Bausch Health Com­pa­nies and Gen­er­al Mo­tors.

Retrophin has tapped Pe­ter Heer­ma as CCO. Heer­ma will be in charge of the com­pa­ny’s com­mer­cial­iza­tion strat­e­gy for ap­proved prod­ucts and pre-com­mer­cial plan­ning of pipeline pro­grams, which in­cludes sparsen­tan — cur­rent­ly be­ing eval­u­at­ed in Phase III tri­als for fo­cal seg­men­tal glomeru­loscle­ro­sis and IgA nephropa­thy. But that group won’t in­clude fos­met­pan­tote­nate, the drug that its no­to­ri­ous founder Mar­tin Shkre­li co-in­vent­ed, af­ter it flopped in a piv­otal tri­al. Most re­cent­ly, Heer­ma was the glob­al prod­uct man­ag­er for on­col­o­gy and car­dio­vas­cu­lar prod­ucts at Am­gen and has al­so served roles at Ab­b­Vie and Ab­bott

→ UK-based VC and life sci­ences com­pa­ny, Ar­ix Bio­science — which re­cent­ly co-led a $63 mil­lion round for drug de­vel­op­er Imarahas an­nounced that their CFO, James Rawl­ing­son is hit­ting the ex­it. Rawl­ing­son is the cur­rent non-ex­ec­u­tive di­rec­tor and chair­man of the au­dit and risk com­mit­tee at Citibank UK. In ad­di­tion, the com­pa­ny’s group fi­nan­cial con­troller, Mar­cus Karia, has been pro­mot­ed to group fi­nance di­rec­tor.  

→ Neoanti­gen play­er PACT Phar­ma has wooed Tim Moore from Kite to run tech­ni­cal ops as the com­pa­ny’s pres­i­dent and chief tech­ni­cal of­fi­cer. The prospect of tack­ling sol­id tu­mors by hit­ting neoanti­gens that form a unique sig­na­ture on each — drew him to the new op­por­tu­ni­ty, Moore told End­points News

In­com­ing Ver­tex CEO Resh­ma Ke­wal­ra­mani has se­lect­ed her re­place­ment as CMO, choos­ing to pro­mote a mem­ber of the R&D team to the post. Car­men Boz­ic, who joined the com­pa­ny last May from Bio­gen, has been named EVP, Glob­al Med­i­cines De­vel­op­ment and Med­ical Af­fairs to­day and gets to add the new ti­tle of CMO next April as Ver­tex cau­tious­ly trans­fers the reins to a new CEO who much to prove in or­der to win over some skep­ti­cal an­a­lysts. Boz­ic’s first job at Ver­tex was lead­ing clin­i­cal de­vel­op­ment of the com­pa­ny’s cys­tic fi­bro­sis and al­pha-1 an­tit­rypsin de­fi­cien­cy pro­grams, as well as clin­i­cal op­er­a­tions across the pipeline. In ad­di­tion, Nia Tat­sis, Ver­tex’s SVP, glob­al reg­u­la­to­ry af­fairs, is tak­ing over as head of reg­u­la­to­ry, ef­fec­tive im­me­di­ate­ly. 

→ Just a lit­tle more than 3 years af­ter Michael Ehlers took the job as glob­al head of R&D for the now deeply trou­bled Bio­gen, he’s jump­ing ship. CEO Michel Vounatsos has ap­point­ed CMO Al San­drock, a chief ar­chi­tect of the drug­mak­er’s deeply flawed pipeline strat­e­gy, as his re­place­ment. Ehlers will go on to a new ca­reer op­por­tu­ni­ty as a ven­ture part­ner and CSO at Ap­ple Tree, which comes with a CEO job at a gene ther­a­py start­up named Lime­light Bio. In ad­di­tion, Vounatsos named Alphonse Galdes ex­ec­u­tive vice pres­i­dent, phar­ma­ceu­ti­cal op­er­a­tions and tech­nol­o­gy.

→ For­mer FDA Com­mis­sion­er Robert Califf and his inim­itable mus­tache will be on proud dis­play as he makes his way to Al­pha­bet to take a full-time role as head of med­ical strat­e­gy and pol­i­cy across the Google Health and Ver­i­ly units, come mid-No­vem­ber. 

→ Ther­a­peu­tic pro­tein man­u­fac­tur­er AGC Bi­o­log­ics has ap­point­ed Jef­frey Mow­ery as site head/gen­er­al man­ag­er of the com­pa­ny’s Copen­hagen, Den­mark fa­cil­i­ty. He will work with his col­leagues in Seat­tle to com­bine the com­pa­ny’s glob­al ca­pa­bil­i­ties. Mow­ery’s pre­vi­ous stints in­clude Juno Ther­a­peu­tics, Lon­za and Genen­tech.

PhRMA has named Jen­nifer Bryant as EVP of pol­i­cy and re­search, suc­ceed­ing Lori Reil­ly who was re­cent­ly ap­point­ed COO. Bryant has been with PhRMA for 13 years and most re­cent­ly served as SVP of pol­i­cy and re­search. Pri­or to her time at PhRMA, Bryant served as vice pres­i­dent at health­care con­sult­ing firm, The Lewin Group and worked at the Blue Cross Blue Shield As­so­ci­a­tion.

Opti­nose has hired Michael Richard­son as VP, busi­ness de­vel­op­ment to beef up its port­fo­lio of po­ten­tial treat­ments for ear, nose and throat. As the com­pa­ny be­gins to mar­ket its Xhance nasal spray for nasal polyps, Richard­son will eval­u­ate new op­por­tu­ni­ties to sup­port long-term growth, the com­pa­ny said. He joins from a com­mer­cial role at Prince­ton Bio­phar­ma.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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Vas Narasimhan. Getty Images

UP­DAT­ED: Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and briefly spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

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IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

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David Liu, Liu Group

David Liu un­veils newest ad­vance­ment in CRISPR tech: Prime edit­ing

The researcher behind base-editing is out with what some scientists are hailing as the biggest advancement in CRISPR technology since that 2016 breakthrough: “prime editing.” The new molecular gadget is capable of erasing any base pair and stenciling in another and cutting or adding long segments of DNA without breaking both strands of the helix.

David Liu, base editing pioneer and founder of Beam Therapeutics, published the findings in Nature alongside Andrew Anzalone. They estimated that the breakthrough “in principle” puts 89% of human diseases in purview — although experts cautioned that human therapies were a long way off.

Bhaskar Chaudhuri. Frazier Healthcare Partners

Fra­zier Health­care Part­ner­s' der­ma­tol­ogy up­start at­tracts a mar­quee syn­di­cate, $94M+ for 'in-be­tween' top­i­cal drug

For the past three years Frazier Healthcare Partners’ Bhaskar Chaudhuri has been carefully and quietly grooming Arcutis Therapeutics, a new dermatology play he co-founded to deliver topical formulations of well-known drugs. Now that the biotech is poised to enter Phase III, he’s being joined by a marquee syndicate for its $94.5 million Series C.

HBM Healthcare Investments, Vivo Capital, BlackRock, Omega Funds, Pivotal BioVentures, and Goldman Sachs jumped on board, joining Bain Capital Life Sciences, OrbiMed and RA Capital Management in backing Arcutis’ lead topical cream for plaque psoriasis.

A new com­pa­ny en­ters the Tec­fidera fight, of­fer­ing to kill two birds

The remedy for the most common side effect for one of the most common multiple sclerosis drugs is simple: aspirin.

Taking aspirin with Biogen’s Tecfidera will reduce the flush, a sometimes painful form of red skin irritation, many patients experiences. The problem is that the aspirin has to be taken at least 30 minutes before Tecfidera, turning a simple twice-a-day, one-dose oral drug into a staggered two-drug regimen.

UP­DAT­ED: Bris­tol-My­ers makes Op­di­vo pitch for front­line lung can­cer with open la­bel PhI­II study

Despite a head start, when Bristol-Myers Squibb and its pioneering checkpoint inhibitor Opdivo suffered a key lung cancer setback in 2016, they found themselves relegated to the backseat as Merck’s Keytruda seized the wheel on the road to immunotherapy stardom. Bristol-Myers has since suffered blow after blow in its quest to take a big slice of the lucrative market, peppered with some small successes. On Tuesday, the New Jersey drugmaker touted positive data from a Phase III open-label study in a bid to carve itself a piece of the frontline lung cancer market.