Jim Wil­son start­up Pas­sage Bio plugs in CFO, CMO; Till­man Gern­gross nabs a COO fa­mil­iar with Covid-19 fight at Pfiz­er as Ada­gio files for IPO

Si­mona King

→ Back in May, Pas­sage Bio CFO Richard Mor­ris and CMO Gary Ro­mano left with­in days of each oth­er, but this week the gene ther­a­py play­er has found their re­place­ments, along with a chief com­mer­cial of­fi­cer. Si­mona King, a 19-year Bris­tol My­ers Squibb vet in fi­nance, be­comes CFO on Aug. 23 af­ter a quick stop in the same post at Tmu­ni­ty Ther­a­peu­tics and a year at Emer­gent BioSo­lu­tions. CMO Mark For­man gets start­ed a week from to­day and was re­cent­ly VP of trans­la­tion­al med­i­cine at Aca­dia Phar­ma­ceu­ti­cals, pre­ced­ed by 11 years at Mer­ck. And Maria Törn­sén, who got the ball rolling as CCO this week, had been Sarep­ta’s SVP, gen­er­al man­ag­er, US.

Mor­ris is cur­rent­ly CFO at Caris­ma Ther­a­peu­tics af­ter leav­ing Pas­sage Bio, which had its FDA hold lift­ed for its in­fan­tile GM1 gan­gliosi­do­sis drug PBGM01 to kick off 2021.

Till­man Gern­gross’ gang at Ada­gio Ther­a­peu­tics filed for an $100 mil­lion IPO this week, but it’s a lock that the Covid-19 an­ti­body biotech will shat­ter that mark when all is said and done. To sup­ple­ment that news, Ada­gio — mov­ing at a pace that be­lies the tem­po mark­ing that bears its name — has tapped David Her­ing as COO. Ada­gio plucks Her­ing from Pfiz­er, where he was at the fore­front of launch­ing the phar­ma gi­ant’s Covid-19 vac­cine can­di­date as the glob­al mR­NA busi­ness lead. He had moved to Pfiz­er in 2015 from a num­ber of roles at No­var­tis Vac­cines, in­clud­ing head of North Amer­i­ca.

Mar­cel­la Rud­dy

Co-found­ed by Tim Springer, led by CEO Alise Re­icin and rais­ing the cur­tain with an $80 mil­lion Se­ries A round in April, Tec­ton­ic Ther­a­peu­tic has picked up a CMO with Mar­cel­la Rud­dy com­ing on board a cou­ple months af­ter Pe­ter Mc­Na­ma­ra as­sumed the head of re­search role. Big names abound in Rud­dy’s track record: 10 years in clin­i­cal re­search at Mer­ck; brief stays as an ex­ec with EMD Serono and Al­ny­lam; and the last five years with Re­gen­eron, where she was VP, glob­al pro­gram di­rec­tion for im­munol­o­gy/in­flam­ma­tion and the pro­gram lead for Dupix­ent be­fore set­ting off for GPCR (G pro­tein-cou­pled re­cep­tor)-fo­cused Tec­ton­ic.

Bill Gross­man

Bill Gross­man has jumped ship from Ar­cus, with an SEC fil­ing in­di­cat­ing that he’ll step in­to the role of SVP, on­col­o­gy clin­i­cal re­search at Gilead — Ar­cus’ col­lab­o­ra­tor on a mam­moth $2 bil­lion im­muno-on­col­o­gy deal — be­gin­ning this com­ing Mon­day. Kar­tik Kr­ish­nan will take over clin­i­cal de­vel­op­ment du­ties for Gross­man, a con­sul­tant for Gilead since De­cem­ber who had served as CMO at Bel­licum for a year un­til he left the trou­bled biotech to ac­cept the CMO job with Ter­ry Rosen-led Ar­cus in 2019.

→ There are changes ga­lore with Kåre Schultz’s crew at Te­va, start­ing with the de­par­ture of North Amer­i­ca com­mer­cial head Bren­dan O’Grady “to pur­sue a ca­reer op­por­tu­ni­ty out­side of the phar­ma­ceu­ti­cal in­dus­try,” which hap­pens to be chief com­mer­cial & growth of­fi­cer at tele­health com­pa­ny Amwell. Get­ting the call from the bullpen to re­place O’Grady as head of North Amer­i­ca com­mer­cial is Sven Deth­lefs, Te­va’s EVP, glob­al mar­ket­ing & port­fo­lio and in­ter­na­tion­al mar­kets com­mer­cial and an em­ploy­ee at the com­pa­ny since 2008. Eli Shani, the head of the glob­al busi­ness de­vel­op­ment and al­liance man­age­ment group who’s been with Te­va the last 15 years, is get­ting pro­mot­ed to Deth­lefs’ pre­vi­ous po­si­tion of EVP, glob­al mar­ket­ing & port­fo­lio.

So who’s tak­ing Deth­lefs’ oth­er old job? We know who it is. That EVP of in­ter­na­tion­al mar­kets com­mer­cial gig will be­long to Mark Sabag, a 15-year Te­va vet who was chief hu­man re­sources of­fi­cer and head of glob­al com­mu­ni­ca­tions, brand and ESG.

So who’s tak­ing Sabag’s old jobs? We know that too. Galia In­bar earns the pro­mo­tion af­ter her time as Te­va’s SVP, head of glob­al peo­ple op­er­a­tions.

The first day for this reshuf­fling is set at Aug. 15.

Ken Fra­zier

Ken Fra­zier’s post-Mer­ck plans are tak­ing shape, chair­ing the health as­sur­ance ini­tia­tives at Gen­er­al Cat­a­lyst and man­ag­ing its $600 mil­lion fund. Gen­er­al Cat­a­lyst chair­man and man­ag­ing di­rec­tor Ken Chenault has known Fra­zier well since their days at Har­vard Law School. “I am ex­cit­ed and proud that he has de­cid­ed to join GC amid the myr­i­ad of choic­es I know he had for this next chap­ter of his ca­reer,” Chenault said in a state­ment. Fra­zier stepped down from Mer­ck a few weeks ago af­ter 29 years with the com­pa­ny, 10 of those as CEO.

Shahram Salek-Ar­dakani

Roger Perl­mut­ter trans­formed Janux Ther­a­peu­tics from a rel­a­tive no­body in­to a def­i­nite some­body when he bet $1 bil­lion-plus on the San Diego biotech’s T cell en­gagers in De­cem­ber 2020 be­fore his “re­tire­ment” from Mer­ck took ef­fect. And this week at David Camp­bell-led Janux, Shahram Salek-Ar­dakani has signed on as CSO. Salek-Ar­dakani spent the last five years at Pfiz­er and was the phar­ma’s se­nior di­rec­tor of can­cer im­munol­o­gy.

Kate McKin­ley

El­e­var Ther­a­peu­tics out of Salt Lake City just popped in­to Peer Re­view a cou­ple weeks ago with a few ap­point­ments — CMO Mau­reen Con­lan among them — but a big­ger change has un­fold­ed at El­e­var as Kate McKin­ley takes the helm, suc­ceed­ing Alex Kim in the top spot. McKin­ley orig­i­nal­ly came to El­e­var to take the CCO job in 2019 af­ter two years at Den­dreon, and from 2000-17, she filled an ex­ten­sive list of roles at Ab­b­Vie, ris­ing to US head of sales and tak­ing charge of the urol­o­gy, on­col­o­gy & gy­ne­col­o­gy fran­chise. And Kim isn’t wan­der­ing off com­plete­ly, swing­ing in­to his new role as chair­man of El­e­var’s board.

Fab­rice Chouraqui and the folks at Cel­lar­i­ty now have an ex-Mor­gan Stan­ley an­a­lyst in their cor­ner as David Risinger takes the CFO spot at the Flag­ship com­pa­ny. Risinger logged 12 years for Mor­gan Stan­ley as man­ag­ing di­rec­tor and head of US ma­jor and spe­cial­ty phar­ma­ceu­ti­cals eq­ui­ty re­search. Cel­lar­i­ty chalked up $123 mil­lion in a Se­ries B in Feb­ru­ary to ad­vance its drug dis­cov­ery plat­form that mix­es net­work bi­ol­o­gy, high-res­o­lu­tion da­ta, and ma­chine learn­ing tech.

Pam Stetkiewicz

→ From the cre­ative mind of Feng Zhang, CRISPR up­start and Ver­tex CF part­ner Ar­bor Biotech­nolo­gies has turned to Pam Stetkiewicz and Kathryn Mc­Cabe to be COO and lead busi­ness de­vel­op­ment, re­spec­tive­ly. Stetkiewicz just spent a year as SVP, glob­al pro­gram leader at Flag­ship’s Pi­o­neer­ing Med­i­cines, and from 2016-20 she was Ed­i­tas Med­i­cine’s VP, pro­gram and al­liance man­age­ment. Mc­Cabe looks to put down roots at Ar­bor af­ter jump­ing around from Big Phar­ma to Big Phar­ma, no­tably Glax­o­SmithK­line, Eli Lil­ly and — just be­fore grab­bing this op­por­tu­ni­ty — Roche, where she was se­nior di­rec­tor of busi­ness de­vel­op­ment in Cam­bridge, MA.

Nicholas Hain­ing

→ Backed by Beth Sei­den­berg and Sean Park­er and launched in the fall of 2019, de­sign­er T cell com­pa­ny Ar­se­nal­Bio has named co-founder Nicholas Hain­ing as CSO. Be­fore jump­ing in­to Ar­se­nal­Bio, Hain­ing was VP of dis­cov­ery on­col­o­gy and im­munol­o­gy at Mer­ck Re­search Lab­o­ra­to­ries. Like Pas­sage Bio, Ar­se­nal­Bio led off the new year with good news of its own, ink­ing a dis­cov­ery deal with Bris­tol My­ers for $70 mil­lion up­front.

→ French hear­ing loss dis­or­der biotech Sen­so­ri­on will bring in Ot­mane Bous­sif as its new chief tech­ni­cal of­fi­cer start­ing Aug. 1. Bous­sif, an EMD Serono and Sanofi Pas­teur vet, brings Big Phar­ma ex­pe­ri­ence to Sen­so­ri­on af­ter six years at No­var­tis in a panoply of po­si­tions rang­ing from glob­al head of cell and gene ther­a­py tech­ni­cal de­vel­op­ment to glob­al head of ear­ly phase de­vel­op­ment.

Pe­ter Ola­gun­ju

TCR² Ther­a­peu­tics im­pressed an­a­lysts last year around this time with da­ta for its T cell ther­a­py TC-210, al­beit with a five-pa­tient sam­ple size. A year lat­er, TCR² has ap­point­ed Fer­Gene’s SVP of tech­ni­cal op­er­a­tions, Pe­ter Ola­gun­ju, as chief tech­ni­cal of­fi­cer. Pri­or to Fer­Gene, Ola­gun­ju was the pro­gram lead for Zyn­te­glo and lat­er the VP of glob­al pa­tient op­er­a­tions for Nick Leschly’s bunch at blue­bird bio. He’s al­so been in­volved in glob­al tech­ni­cal op­er­a­tions at Den­dreon.

San­dra Horn­ing

Alex­is Borisy’s EQRx has as­sem­bled a mis­sion ad­vi­so­ry board to — nat­u­ral­ly — “guide the Com­pa­ny’s vi­sion and mis­sion-crit­i­cal ac­tiv­i­ties fo­cused on bring­ing more af­ford­able med­i­cines to the peo­ple who need them glob­al­ly,” the state­ment reads. A few of the head­lin­ers in­clude long­time Roche ex­ec (and EQRx co-founder) San­dra Horn­ing, ex-Pfiz­er CMO Mace Rothen­berg and ex-Sanofi glob­al R&D chief Elias Zer­houni, while Otis Braw­ley, Richard Schilsky, Ellen Si­gal and Gail Wilen­sky join them. Look­ing to shake up the drug pric­ing mod­el, EQRx part­nered with AI play­er Ex­sci­en­tia a month ago to de­vel­op less ex­pen­sive on­col­o­gy and im­munol­o­gy drugs.

Kim­ber­ly Lind­strom

→ San Fran­cis­co’s Es­ker Ther­a­peu­tics, which made its de­but in May with a $70 mil­lion Se­ries A — all from Fore­site Cap­i­talhas wel­comed Kim­ber­ly Lind­strom as VP, reg­u­la­to­ry and Travis Re­marchuk as ex­ec­u­tive di­rec­tor, CMC. Lind­strom, the ex-se­nior di­rec­tor of reg­u­la­to­ry af­fairs at Bris­tol My­ers, had held the same ti­tle at MyoKar­dia be­fore the $13 bil­lion buy­out. And Re­marchuk was re­cent­ly CMC di­rec­tor and staff sci­en­tist with Ryan Watts’ team at De­nali. Es­ker has al­so scored a big board ap­point­ment with Bing Yao, the ex-CEO at Viela Bio who is now helm­ing Ar­riVent Bio­phar­ma.

On­ly Es­ker and Ses­ti­na Bio have been un­veiled so far as part of the five biotechs that Vik Ba­jaj is fir­ing up at Fore­site Labs, as dis­cussed in an End­points News ex­clu­sive with our Am­ber Tong.

Matthew Navar­ro

Matthew Navar­ro has tak­en on the role of CFO at Gilead’s NASH part­ner Glympse Bio. Once the se­nior man­ag­er, strat­e­gy, port­fo­lio man­age­ment and com­mer­cial op­er­a­tions at Pfiz­er, Navar­ro used to lead East Coast bio­phar­ma cov­er­age as man­ag­ing di­rec­tor at Perel­la Wein­berg Part­ners. Last year around this time, Car­olyn Loew-led Glympse racked up $46.7 mil­lion in a Se­ries B round, set­ting up the biotech to fur­ther de­vel­op its biosen­sor plat­form.

→ Not to be con­fused with the for­mer Uni­ver­si­ty of Texas quar­ter­back, J&J and No­var­tis alum Chris Simms will sur­vey the op­tions on the field as chief com­mer­cial of­fi­cer of reti­nal dis­ease-fo­cused Iver­ic Bio start­ing Aug. 2. Simms makes this change fol­low­ing a stay at No­var­tis where he led the US oph­thalmics busi­ness unit — the home of Beovu and Xi­idra. He was al­so the mar­ket­ing lead for Lu­cen­tis dur­ing his four years at Genen­tech.

→ Sit­ting pret­ty with a mas­sive Se­ries C to­tal­ing $276 mil­lion, San Diego DNA se­quenc­ing play­er El­e­ment Bio­sciences has wel­comed three ex­ecs to the team. Chief peo­ple of­fi­cer Bri­an Stolz held this po­si­tion be­fore at videogame mak­er Ac­tivi­sion Bliz­zard and then be­came Neil Ku­mar’s COO at Bridge­Bio. Di­ana King comes to El­e­ment as VP of cus­tomer sup­port af­ter al­most two years as chief busi­ness de­vel­op­ment of­fi­cer at med­ical imag­ing com­pa­ny Mul­ti, Inc. And VP of en­gi­neer­ing Jor­dan Ney­smith was pre­vi­ous­ly the se­nior di­rec­tor of de­vel­op­ment and en­gi­neer­ing for Bruk­er Nano Sur­faces.

Eliz­a­beth White

→ For the third time in four weeks, Philly’s Ren­o­va­cor makes an ap­pear­ance at Peer Re­view, this time with CBO and SVP of op­er­a­tions Eliz­a­beth White. She joins all the oth­er new­bies at the AAV-based gene ther­a­py biotech from NeuEx­cell Ther­a­peu­tics — an­oth­er Penn­syl­va­nia com­pa­ny — where she served as chief busi­ness and strat­e­gy of­fi­cer. White closed out her 15 years at Pfiz­er lead­ing com­mer­cial de­vel­op­ment for the rare dis­ease and gene ther­a­py busi­ness.

→ Can­cer biotech Ite­ri­on Ther­a­peu­tics out of Hous­ton has se­lect­ed Jean Chang as COO. A nine-year Dy­navax alum in cor­po­rate and pro­gram de­vel­op­ment with ear­ly stops at Gen­zyme and Gilead, Chang has served as Nurix Ther­a­peu­tics’ VP, pro­gram man­age­ment and as­set strat­e­gy be­fore mov­ing on to Ite­ri­on, which has its lead can­di­date tega­vivint in a Phase I/IIa tri­al to treat pro­gres­sive desmoid tu­mors.

Doug Man­ion

→ An­oth­er op­por­tu­ni­ty has opened up for Doug Man­ion, the CEO of Kleo Phar­ma­ceu­ti­cals be­fore Bio­haven swooped in to buy the com­pa­ny in Jan­u­ary. Man­ion is now EVP of R&D for Amit Mun­shi at Are­na Phar­ma­ceu­ti­cals, which suf­fered dou­ble duds with its lead drug etrasi­mod for atopic der­mati­tis and then with olorinab for IBS pain. Be­fore his tenure at Kleo, Man­ion had an 11-year run at Bris­tol My­ers that saw him lead spe­cial­ty de­vel­op­ment and R&D in Japan and Chi­na.

→ Hel­lo, New­man: Rockville, MD-based Im­mu­nom­ic Ther­a­peu­tics has pegged Robert New­man as CBO. A for­mer SVP at Zio­pharm On­col­o­gy, New­man makes his way to Im­mu­nom­ic — a biotech work­ing on a den­drit­ic cell vac­cine for glioblas­toma mul­ti­forme dubbed ITI-1000 — af­ter a stint as gen­er­al man­ag­er of WCG Anal­gesic So­lu­tions.

Ajay Rai

→ When the FDA pressed pause on Sig­ilon’s he­mo­phil­ia A pro­gram a cou­ple weeks ago with a clin­i­cal hold, it was the kind of stum­ble you don’t nor­mal­ly see from Flag­ship’s sta­ble of com­pa­nies. While Sig­ilon picks it­self up and dusts it­self off, the biotech co-found­ed by Bob Langer has al­so re­cruit­ed Ajay Rai as SVP, head of busi­ness de­vel­op­ment. Since leav­ing Take­da in 2018 as se­nior di­rec­tor of cor­po­rate de­vel­op­ment, Rai had been VP, cor­po­rate de­vel­op­ment, strat­e­gy & al­liance man­age­ment with Fre­quen­cy Ther­a­peu­tics.

David Proia

→ When in ROME: Three new staffers have emerged at Rosana Kapeller’s ROME Ther­a­peu­tics, which puts “junk DNA” known as the re­peatome in the spot­light. David Proia (VP, on­col­o­gy) breaks away from his role as C4 Ther­a­peu­tics’ se­nior di­rec­tor, in vi­vo phar­ma­col­o­gy; Men­achem Fromer (head of da­ta sci­ence) is the for­mer da­ta sci­ence and R&D lead at Ver­i­ly Life Sci­ences; and Sarah Knut­son (se­nior di­rec­tor, ear­ly dis­cov­ery) just spent more than two years at Kazu­mi Sh­iosa­ki start­up Twen­tyeight-Sev­en and is the ex-as­so­ciate di­rec­tor of dis­cov­ery bi­ol­o­gy at Nim­bus, where Kapeller was the found­ing CSO.

Bren­da Mar­czi has been named SVP of reg­u­la­to­ry af­fairs at San Diego-based can­cer biotech Tra­con Phar­ma­cuet­i­cals. Mar­czi was a reg­u­la­to­ry ex­ec from 2011-20 at Fer­ring Phar­ma­ceu­ti­cals and VP, reg­u­la­to­ry and clin­i­cal af­fairs at Ea­gle Phar­ma­ceu­ti­cals.

→ Cam­bridge, MA on­col­o­gy up­start Im­muneer­ing has locked in Michael Book­man as gen­er­al coun­sel and sec­re­tary. Book­man joins a staff that in­cludes ex-Jef­feries an­a­lyst Biren Amin af­ter his time as gen­er­al coun­sel and sec­re­tary at Fre­quen­cy Ther­a­peu­tics.

John John­son

→ Flori­da-based Ax­o­gen, a de­vel­op­er of prod­ucts for pe­riph­er­al nerve re­pair, has pulled in Big Phar­ma lu­mi­nary John John­son for its board of di­rec­tors. The J&J and Eli Lil­ly vet, who was once the CEO at Melin­ta, is en­ter­ing his sec­ond year as CEO of Strong­bridge Bio­phar­ma.

Diem Nguyen

Paul Pe­ter Tak-led on­colyt­ic virus biotech Can­del Ther­a­peu­tics, shoot­ing for that cus­tom­ary $100 mil­lion num­ber with its IPO, has elect­ed Diem Nguyen to the board of di­rec­tors. The Pfiz­er vet­er­an is in her first year as CEO of Xalud Ther­a­peu­tics.

Or­biMed-backed Pre­lude Ther­a­peu­tics out of Delaware has added Mar­tin Babler to the board of di­rec­tors. Babler scores this board ap­point­ment at the on­col­o­gy out­fit af­ter Sanofi’s $3.7 bil­lion pur­chase of Prin­cip­ia Bio­phar­ma end­ed his nine-year run as Prin­cip­ia’s chief ex­ec­u­tive.

Stacey Ma

Stacey Ma and Stephen Brady are now mem­bers of Atre­ca’s board of di­rec­tors. Ma, who spent more than two decades at Roche/Genen­tech, is Sana’s EVP and head of tech­ni­cal op­er­a­tions (as well as a 2020 Women in Bio­phar­ma hon­oree at End­points News), while Brady first came to Tem­pest Ther­a­peu­tics as pres­i­dent and COO be­fore his June pro­mo­tion to CEO.

Voy­ager’s CFO and prin­ci­pal fi­nance and ac­count­ing of­fi­cer Al­li­son Dor­val now owns a spot on the board of di­rec­tors at Aerovate. Led by Tim­o­thy Noyes, Aerovate made its Nas­daq de­but with an up­sized IPO amount­ing to $121.5 mil­lion a few weeks ago.

Vista­Gen is grow­ing its board of di­rec­tors fur­ther with Mag­gie Fitz­Patrick, the for­mer chief com­mu­ni­ca­tions of­fi­cer with J&J who just had a four-year run as a cor­po­rate af­fairs ex­ec with Ex­elon. CNS-fo­cused Vista­Gen has al­so named Joanne Cur­ley and Mary Ro­tun­no to the board since April.

AUTHOR

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.