Ex-As­traZeneca ex­ec Kris­ten Buck hops aboard Icon as CMO; Im­muno­core taps Bri­an Di­Do­na­to as CFO

Kris­ten Buck

→ Promi­nent CRO play­er Icon is bol­ster­ing its lead­er­ship, with Kris­ten Buck tak­ing the reins as CMO.

For slight­ly more than a year and a half, Buck was the SVP & chief of clin­i­cal de­vel­op­ment at Op­tum, part of the Unit­ed­Health con­glom­er­ate. When she got there, she had al­ready held a post at the FDA in the gas­troin­testi­nal and hema­tol­ogy di­vi­sion, tasked with post-mar­ket­ing safe­ty for over 40 drugs. She had al­so spent 6 years as an ex­ec at As­traZeneca in clin­i­cal de­vel­op­ment and in its in­no­v­a­tive med­i­cines group.

Her back­ground cov­ers an ar­ray of ther­a­py ar­eas, in­clud­ing GI, women’s health, oph­thal­mol­o­gy, neu­ro­science, der­ma­tol­ogy, on­col­o­gy, liv­er, or­phan dis­eases and psy­chi­a­try.

Buck was a track and field ath­lete at the Uni­ver­si­ty of Vir­ginia and then moved on to Penn State to re­ceive her MD. She stayed in Penn­syl­va­nia to com­plete her in­tern­ship and res­i­den­cy in in­ter­nal med­i­cine at Abing­ton Memo­r­i­al Hos­pi­tal.

Dublin-based Icon won Best Con­tract Re­search Or­ga­ni­za­tion (full-ser­vice providers) in De­cem­ber at the Scrip Awards in Lon­don.

“I’m ex­cit­ed to be lead­ing ICON’s po­si­tion on clin­i­cal de­vel­op­ment trends, and re­view­ing and ad­vis­ing on our med­ical risks as the world wres­tles with the Covid-19 pan­dem­ic,” Buck said in a state­ment. “Pa­tient cen­tric­i­ty is ever more im­por­tant in the cur­rent cli­mate and I look for­ward to work­ing with the wider ICON team to broad­en our in­sights and ex­pand our ex­per­tise.”

Bri­an Di­Do­na­to has jumped in as CFO and head of strat­e­gy of TCR-fo­cused Im­muno­core, which is mov­ing on from Neil Wood­ford af­ter scor­ing a $130 bil­lion Se­ries B haul in March. Di­Do­na­to was most re­cent­ly the SVP and CFO at Achillion Phar­ma­ceu­ti­cals, ac­quired by Alex­ion. Oth­er pre­vi­ous stops for Di­Do­na­to in­clude Sorin Cap­i­tal Man­age­ment, Cap­mark In­vest­ments as pres­i­dent and chief in­vest­ment of­fi­cer, Mor­gan Stan­ley and UBS Se­cu­ri­ties.

→ While work­ing to­wards its goal of pro­duc­ing 1 bil­lion vac­cines to fight Covid-19, as well as be­ing the com­pa­ny with one of the lead­ing vac­cines now in the clin­ic, Mod­er­na has ramped up its team with some new ap­point­ments. This comes af­ter news of their CFO Lorence Kim hit­ting the ex­it af­ter 6 years with the Boston-based up­start. Patrick Berg­st­edt, Jacque­line Miller and Char­bel Haber have all hopped aboard to help with the com­pa­ny’s light­ning-fast cam­paign. Berg­st­edt, a Mer­ck vet, is step­ping in as SVP for com­mer­cial vac­cines; Miller hails from GSK and comes in as SVP of in­fec­tious dis­ease de­vel­op­ment and Haber, mean­while, leaps over from Bio­gen as SVP of reg­u­la­to­ry af­fairs.

Na­jat Khan

→ Over at J&J, Na­jat Khan has tran­si­tioned in­to the role of chief da­ta sci­ence of­fi­cer. Pre­vi­ous­ly, Khan had served as the COO in the re­search arm. R&D chief Math­ai Mam­men praised Khan for her bilin­gual ex­per­tise in two key lan­guages: the sci­ence of drug de­vel­op­ment as well as da­ta sci­ences. And han­dled prop­er­ly, that can guide R&D to more wins with low­er costs — a long­time mantra in a world where ROI is gen­er­al­ly sore­ly lack­ing. Pri­or to jump­start­ing her role at J&J, Khan served as a phar­ma con­sul­tant at the Boston Con­sult­ing Group.

→ Sin­ga­pore biotech Tes­sa Ther­a­peu­tics, which fo­cus­es on can­cer cell ther­a­pies, has un­der­gone a few lead­er­ship changes. An­drew Khoo has stepped aside as CEO but will re­main on Tes­sa’s board, and Jef­frey Buchal­ter, a board mem­ber since last March, has suc­ceed­ed him. Buchal­ter has been pres­i­dent and CEO of Archimedes Phar­ma­ceu­ti­cals, En­zon Phar­ma­ceu­ti­cals and Ilex On­col­o­gy. Chair­man of the board Teo Ming Kian al­so stepped down ef­fec­tive May 1, with for­mer No­vo Nordisk chair­man Göran An­do set to take his place.

Jef­frey Buchal­ter

→ Ex­pand­ing his role at CNS-fo­cused Im­pel Neu­roPhar­ma, Adri­an Adams is now the chair­man and CEO ef­fec­tive im­me­di­ate­ly, re­plac­ing Jon Con­gle­ton. Adams was named chair­man of Im­pel’s board in Jan­u­ary, and be­fore then, he held nu­mer­ous CEO posts, in­clud­ing at Ar­alez Phar­ma­ceu­ti­cals, Aux­il­i­um Phar­ma­ceu­ti­cals (un­til its ac­qui­si­tion by En­do In­ter­na­tion­al plc) and Neu­rologix.

→ Along with chang­ing its name, Trovagene is do­ing some C-suite shuf­fling. Now called Cardiff On­col­o­gy, the San Diego-based pre­ci­sion can­cer meds com­pa­ny de­vel­op­ing the can­cer drug on­va­nsert­ib is pro­mot­ing Mark Er­lan­der to CEO, while Thomas Adams tran­si­tions from chair­man and CEO to ex­ec­u­tive chair­man. Er­lan­der had been the for­mer Trovagene’s CSO since 2013.

Mark Er­lan­der

Tim­o­thy Jones will lead Respir­eRx Phar­ma­ceu­ti­cals as pres­i­dent and CEO, re­plac­ing Arnold Lip­pa, who served in those ca­pac­i­ties on an in­ter­im ba­sis. Lip­pa stays on as ex­ec­u­tive chair­man and CSO. Since Jan­u­ary, Jones had been on the board of Respir­eRx, which tar­gets treat­ment op­tions for such con­di­tions as ob­struc­tive sleep ap­nea and AD­HD, and or­phan dis­eases such as Frag­ile X syn­drome. Jones heads to Respir­eRx from Purisys, where he was VP of glob­al phar­ma­ceu­ti­cal and med­ical OTC.

Ra­jiv Khosla has been se­lect­ed as CEO of NJ-based En­teris Bio­Phar­ma, re­plac­ing Joel Tune, who had been CEO the last four years. Be­fore he be­gan at En­teris, which de­vel­oped oral de­liv­ery tech­nol­o­gy called Peptel­li­gence, Khosla found­ed Ceutec, a busi­ness de­vel­op­ment con­sul­tan­cy that served bio­phar­mas and VCs. He was al­so at Bio­vail as VP of busi­ness de­vel­op­ment.

Tony Gib­ney

→ Last year around this time, Fog­Phar­ma in­tro­duced CSO Howard Stern. This week the Mass­a­chu­setts biotech has a new CFO and CBO in Tony Gib­ney, the for­mer EVP and CBO of Achillion who led the com­pa­ny’s sale to Alex­ion. Be­fore Achillion, Gib­ney’s life sci­ence in­vest­ment bank­ing ex­pe­ri­ence in­cludes stints at SVB Leerink, Mer­rill Lynch and Lehman Broth­ers.

→ Mi­lan-based Pin­Cell, which tar­gets rare der­ma­to­log­i­cal dis­eases and raised €1.65 mil­lion in seed fi­nanc­ing led by Sofinno­va Part­ners, has named Gabriel­la Cam­boni as CEO and will be a mem­ber of the board of di­rec­tors. Nordic Nanovec­tor CEO Lui­gi Cos­ta has al­so been pegged as chair­man of Pin­Cell’s board, and Pao­la Pozzi, a part­ner at Sofinno­va Part­ners, will al­so join as a board mem­ber.

Chris­tine Matthews

→ With the FDA ac­cept­ing the NDA for its mi­graine drug Qtryp­ta in March, Zosano Phar­ma has se­lect­ed Chris­tine Matthews as CFO. She was the Cal­i­for­nia bio­phar­ma’s in­ter­im CFO since Feb­ru­ary and was an ac­count­ing and fi­nan­cial con­sul­tant with RGP be­fore her time with Zosano. Matthews was al­so di­rec­tor of fi­nan­cial plan­ning & analy­sis at Cepheid and be­gan her ca­reer at Arthur An­der­sen.

Dou­glas Pagán is mov­ing to Dicer­na to be­come CFO, ef­fec­tive May 26. Be­fore join­ing Dicer­na, which an­nounced an RNAi col­lab­o­ra­tion with Al­ny­lam in April for al­pha 1 liv­er dis­ease, Pagán will wrap up his tenure as CFO and sec­re­tary of KSQ Ther­a­peu­tics. Pri­or to that, he was CFO of Paratek Phar­ma­ceu­ti­cals for five years.

→ A cou­ple of new moves have been made at Spruce Bio­sciences, which re­leased pos­i­tive re­sults in Sep­tem­ber from its Phase II study of its lead can­di­date tildac­er­font in adults with con­gen­i­tal adren­al hy­per­pla­sia. Samir Gharib joins the team as CFO, com­ing from Stemed­ica Cell Tech­nolo­gies where he had the same role. Mean­while, Dasharatha Red­dy is on board as VP of phar­ma­ceu­ti­cal de­vel­op­ment and man­u­fac­tur­ing. She was pre­vi­ous­ly head of CMC at Lan­dos Bio­phar­ma.

An­drew Guggen­hime

→ Fresh off $100 mil­lion Se­ries D fi­nanc­ing to help take its Pre­vnar 13 ri­val SVX-24 to the clin­ic, SutroVax has wel­comed An­drew Guggen­hime as CFO and CBO. Guggen­hime was Demi­ra’s CFO from 2014 un­til Eli Lil­ly ac­quired the com­pa­ny in Feb­ru­ary. He has a pletho­ra of oth­er CFO roles to his cred­it, in­clud­ing at Car­dioDx, Cal­is­to­ga Phar­ma­ceu­ti­cals and Facet Biotech Cor­po­ra­tion.

→ Can­cer ther­a­py-fo­cused An­chi­ano is ap­point­ing Steve Di­Pal­ma as its CFO. Di­Pal­ma had been a se­nior fi­nan­cial ad­vi­sor to Cam­bridge, MA-based An­chi­ano the last two years, in ac­cor­dance with Dan­forth Ad­vi­sors. His pre­de­ces­sor, Jonathan Bur­gin, is leav­ing as the biotech clos­es its Is­rael of­fices and fa­cil­i­ties. Di­Pal­ma has held lead­er­ship roles at nu­mer­ous com­pa­nies, in­clud­ing Fo­rum Phar­ma­ceu­ti­cals, RXi Phar­ma­ceu­ti­cals, and at Cat­a­lyst On­col­o­gy, where he was pres­i­dent and CEO.

→ For­mer Pfiz­er ex­ec Robert Fo­er­ster has signed on to be CFO at Oligomer­ix, a Bronx biotech de­vel­op­ing nov­el ther­a­peu­tics for Alzheimer’s dis­ease and re­lat­ed neu­rode­gen­er­a­tive dis­or­ders. Dur­ing his tenure with the phar­ma gi­ant, Fo­er­ster as­sumed such roles as se­nior di­rec­tor, com­mer­cial de­vel­op­ment for emerg­ing mar­kets and se­nior di­rec­tor of Pfiz­er Japan’s busi­ness de­vel­op­ment di­vi­sion.

→ With its Neu­trox fam­i­ly of prod­ucts that in­cludes Aven­o­va and CelleRx, Nov­aBay Phar­ma­ceu­ti­cals has a new CFO. An­drew Jones has jumped on board to re­place the in­ter­im CFO, Lynn Christo­pher, who con­tin­ues in a con­sul­tan­cy role. Jones was pre­vi­ous­ly VP, fi­nance of MyoScience for a lit­tle over a year un­til Paci­ra Bio­Sciences ac­quired it last Au­gust.

→ Speak­ing of Paci­ra Bio­sciences, which fo­cus­es on non-opi­oid treat­ments, the com­pa­ny has brought in Don­ald Man­ning to be CMO. Man­ning had been CMO of Ad­ynxx since 2012, and he al­so held po­si­tions at No­var­tis (glob­al head of anal­gesics de­vel­op­ment) and Cel­gene (VP and neu­ro­sciences ther­a­peu­tic area head).

Noreen Henig

→ Af­ter CMO stints at Breath Ther­a­peu­tics and Pro­QR Ther­a­peu­tics, Noreen Henig is tak­ing on the same CMO role at Kezar Life Sci­ences, which fo­cus­es on treat­ments for au­toim­mune dis­eases and can­cer. Pri­or to Pro­QR, Henig spent six years at Gilead, no­tably as se­nior di­rec­tor, glob­al med­ical af­fairs, res­pi­ra­to­ry and PAH.

→ Pa­lo Al­to-based Life­Max Lab­o­ra­to­ries, which in April was grant­ed fast track des­ig­na­tion for LM-030 li­censed from No­var­tis and in a Phase II/III piv­otal clin­i­cal tri­al for treat­ing Nether­ton syn­drome, has tapped Michael Huang as its CMO. Huang was CMO of Spruce Bio­sciences and was pre­vi­ous­ly VP of clin­i­cal de­vel­op­ment at both Reg­u­lus Ther­a­peu­tics and Aus­pex Phar­ma­ceu­ti­cals.

GSK vet Ian Catch­pole has land­ed the CSO po­si­tion at Ho­ra­ma af­ter some con­sult­ing work and a gig as di­rec­tor of re­search at TC Bio­pharm. Catch­pole was at GSK for 25 years, cap­ping his tenure as “cell and gene ther­a­py dis­cov­ery” trans­la­tion­al leader and by be­ing named a GSK Fel­low in 2016. His ex­per­tise al­so ex­tends to oph­thal­mol­o­gy, vac­ci­na­tion and im­muno-on­col­o­gy.

Elaine Jones

→ Los An­ge­les biotech Myst Ther­a­peu­tics, which de­vel­ops se­lect­ed TIL-based au­tol­o­gous T cell (Pu­riT) ther­a­py prod­ucts for can­cer, has tapped George Smith as VP of busi­ness op­er­a­tions. Smith was the founder and in­te­grat­ed pro­gram lead at Iqvia’s Gene Ther­a­py Cen­ter and their se­nior di­rec­tor, port­fo­lio and in­no­va­tion.

→ Im­munother­a­py-fo­cused Grit­stone On­col­o­gy has ap­point­ed Elaine Jones as chair of the board of di­rec­tors. From 2008 to 2019, Jones was vice pres­i­dent, world­wide busi­ness de­vel­op­ment and se­nior part­ner at Pfiz­er Ven­tures and has been gen­er­al part­ner at Eu­clid­SR Part­ners.

Nordic Nanovec­tor is reshuf­fling its ex­ec team in an ef­fort of cost-sav­ing ini­tia­tives an­nounced in ear­ly April. CFO Tone Kvåle and chief hu­man re­sources of­fi­cer Ri­ta Dege have part­ed ways with the com­pa­ny. Mean­while, Ma­lene Brond­berg, VP in­vestor re­la­tions and cor­po­ra­tion com­mu­ni­ca­tions, has been ap­point­ed CFO. Brond­berg joined the com­pa­ny in Feb­ru­ary 2018 and brought ex­pe­ri­ence from her time with The re­struc­tur­ing has re­duced the num­ber of ex­ec­u­tives from nine to sev­en.

Codex­is has filled two new­ly-cre­at­ed po­si­tions. Ste­fan Lutz has stepped in as SVP, re­search, and Karl Schoene is al­so div­ing in as SVP, de­vel­op­ment and op­er­a­tions. Lutz was a pro­fes­sor and chair of the chem­istry de­part­ment at Emory, while Schoene had pre­vi­ous­ly been pres­i­dent, CEO and di­rec­tor of El­e­vance Re­new­able Sci­ences.

→ Part­ner­ing with Pfiz­er on its an­ti­sense ther­a­py AKCEA-ANGPTL3-LRx, Akcea Ther­a­peu­tics has cho­sen Car­la Poul­son as SVP and chief hu­man re­sources of­fi­cer. Poul­son makes the tran­si­tion to Akcea, ma­jor­i­ty owned by Io­n­is, from Ver­tex, where she was VP, se­nior hu­man re­sources busi­ness part­ner.

Stephen Mi­gausky Imara

→ Af­ter the an­nounce­ment of their CMO hit­ting the ex­it late last month, NEA-found­ed Imara has added Stephen Mi­gausky to the ranks as SVP, le­gal and gen­er­al coun­sel. Pri­or to join­ing Imara, Mi­gausky served as gen­er­al coun­sel at Ar­Qule and has pre­vi­ous­ly served in roles at Ver­tex.

Scott Byrd, Ian Mills and Gor­don Mc­Mur­ray have joined Fra­zier Health­care Part­ners as en­tre­pre­neur-in-res­i­dence con­sul­tants. The three were pre­vi­ous­ly a part of the man­age­ment team at Fra­zier port­fo­lio com­pa­ny Out­post Med­i­cine and served as CEO, CMO and CSO re­spec­tive­ly. They have re­cent­ly formed Pi­o­neer Ther­a­peu­tics. For­mer­ly, Byrd was pres­i­dent and COO at Aca­cia Phar­ma; Mills was head of clin­i­cal de­vel­op­ment at Mit­subishi Tan­abe Phar­ma Eu­rope and Mc­Mur­ray had a stint at Pfiz­er Glob­al R&D.

→ Next-gen T cell play­er TCR² Ther­a­peu­tics — which snagged a $75M IPO last year — has added Stephen Web­ster, the for­mer CFO of Spark Ther­a­peu­tics, to its board of di­rec­tors. Web­ster will take over for Mitchell Fin­er who is step­ping down from the board.

Stephen Web­ster

→ Af­ter rais­ing $200M-plus for their IPO in Feb­ru­ary, drug dis­cov­ery soft­ware play­er Schrödinger has wel­comed Jef­frey Chodake­witz and Gary Gins­berg to its board of di­rec­tors. Chodake­witz pre­vi­ous­ly held posts at Ver­tex and Mer­ck, while Gins­berg served stints at Time Warn­er and Soft­bank Group.

ALX On­col­o­gy, which de­vel­ops ther­a­pies that block the CD47 check­point path­way, has ap­point­ed Rekha Hem­ra­jani to its board of di­rec­tors. Hem­ra­jani is the pres­i­dent and CEO of Ar­a­vive and the for­mer COO and CFO of Ar­cus Bio­sciences.

Re­cur­sion, which bills it­self as the first AI biotech to launch hu­man tri­als, has en­list­ed R Mar­tin Chavez and Ter­ry-Ann Bur­rell to its board of di­rec­tors. Chavez is the for­mer CFO, chief in­for­ma­tion of­fi­cer and glob­al co-head of the se­cu­ri­ties di­vi­sion at Gold­man Sachs and Bur­rell cur­rent­ly serves as CFO of Beam Ther­a­peu­tics.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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En­her­tu picks up an­oth­er win for As­traZeneca and Dai­ichi Sankyo, join­ing the pri­or­i­ty re­view lane for gas­tric can­cer

Five months after Enhertu received twin breakthrough therapy designations, AstraZeneca and Daiichi Sankyo are one step closer to nabbing another approval for their potential blockbuster drug.

The companies announced Wednesday morning that their billion-dollar antibody-drug conjugate has received priority review for HER2 positive metastatic gastric cancer. Already approved in the US for third-line metastatic breast cancer patients that are HER2 positive, Enhertu’s gastric cancer PDUFA date is scheduled for the first quarter of 2021.

Sci­en­tists warn Amer­i­cans are ex­pect­ing too much from a coro­n­avirus vac­cine

The White House and many Americans have pinned their hopes for defeating the Covid-19 pandemic on a vaccine being developed at “warp speed.” But some scientific experts warn they’re all expecting too much, too soon.

“Everyone thinks COVID-19 will go away with a vaccine,” said William Haseltine, chair and president of Access Health International, a foundation that advocates for affordable care.

No­var­tis CEO Vas Narasimhan signs off on a $231M deal to try some­thing new in the R&D fight against SARS-CoV-2

Patrick Amstutz was baptized by pandemic fire early on.

He and colleagues attended the notorious Cowen conference in early March that included some of the top Biogen execs who helped trigger a superspreader event in Boston. Heading back to his post as CEO of Molecular Partners in Switzerland, the outbreak was sweeping through Italy, triggering near panic in some quarters and creeping into the voices of people he knew, including one friend on the Italian side of the country.

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Cedric Francois, Apellis CEO (Optum via YouTube)

UP­DAT­ED: So­bi bets $250M cash, about $1B in mile­stones for rights to a C3 ther­a­py be­ing pushed through 5 piv­otal tri­als

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early- and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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