Ex-Gilead R&D chief Bischof­berg­er starts over as CEO of Kro­nos Bio; Sue Ma­ho­ny steps down from Lil­ly On­col­o­gy

→ Af­ter spend­ing the past 30 years be­fore the R&D mast at Gilead, ex-re­search chief Nor­bert Bischof­berg­er is start­ing over from scratch. This morn­ing, just a few weeks af­ter his for­mal de­par­ture from the head job at one of the world’s top 15 drug re­search or­ga­ni­za­tions, Bischof­berg­er is jump­ing on board at an up­start biotech with just four full-time staffers. He’s chipped in to an $18 mil­lion seed round — rough­ly 1/200th the size of this year’s R&D bud­get at Gilead — to launch Kro­nos Bio. The biotech in-li­censed a plat­form tech­nol­o­gy out of the lab of MIT pro­fes­sor An­gela Koehler fo­cused on mod­u­lat­ing tran­scrip­tion fac­tors in can­cer, with two pre­clin­i­cal pro­grams fo­cused on MYC and the red-hot an­dro­gen re­cep­tor tar­get. 

Sue Ma­ho­ny

→ Just as Eli Lil­ly $LLY is be­gin­ning to catch up in can­cer R&D, Sue Ma­ho­ny, pres­i­dent of Lil­ly On­col­o­gy, an­nounced that she is re­tir­ing from her com­pa­ny of 18 years. Hav­ing led the unit through the in­te­gra­tion of Im­Clone af­ter the $6.5 bil­lion ac­qui­si­tion in 2008, as well as the launch of sev­er­al key drugs, Ma­ho­ny re­cent­ly led the “re­fo­cus­ing of the com­pa­ny’s on­col­o­gy R&D strat­e­gy.” It’s been a quick-fire process marked by the re­cruit­ment of top in­ves­ti­ga­tor Leena Gand­hi, $1.6 bil­lion buy­out of Ar­mo Bio and a $576 mil­lion deal to ac­quire Au­r­Ka Phar­ma. The In­di­anapo­lis-based phar­ma is con­sid­er­ing in­ter­nal and ex­ter­nal can­di­dates to suc­ceed Ma­ho­ny, whom they praise for a “pas­sion for pa­tients and strong sense of pur­pose.”

J Craig Ven­ter is re­tir­ing from Hu­man Longevi­ty, the an­ti-ag­ing start­up he found­ed, sev­er­al months af­ter he grabbed the reins back from Cyn­thia Collins. He will be re­turn­ing to the J Craig Ven­ter In­sti­tute to con­tin­ue his work, he tweet­ed.

→ Af­ter ex­per­i­ment­ing with a num­ber of plat­form tech­nolo­gies, Dean Falb is lend­ing his ear­ly-stage de­vel­op­ment skills to Log­icBio Ther­a­peu­tics as its CSO. The Cam­bridge, MA-based biotech is de­vel­op­ing gene ther­a­pies with a fo­cus on rare pe­di­atric dis­eases, and the ex­ecs like Falb’s back­ground as both a sci­en­tist and an en­tre­pre­neur: Falb co-found­ed Syn­log­ic and, un­til re­cent­ly, led its ef­forts to syn­thet­i­cal­ly en­gi­neer mi­crobes for treat­ment of rare dis­ease and can­cer. Be­fore that, he spent a cou­ple of years at At­las Ven­ture guid­ing the launch of ear­ly-stage life sci­ence com­pa­nies — and that’s af­ter lead­ing dis­cov­ery of bone mor­phogenic pro­tein drugs at Stryk­er Re­gen­er­a­tive Med­i­cine. He will now be front and cen­ter as Log­icBio plans a re­search strat­e­gy for its GeneR­ide tech.

Richard Mar­shall

→ Copen­hagen-based Galec­to Biotech has tapped GSK vet Richard Mar­shall to lead its piv­ot in­to late-stage stud­ies. As CMO, Mar­shall’s is tasked with first ex­e­cut­ing a PhI­Ib study for the in­haled galectin-3 in­hibitor TD139 in id­io­path­ic pul­monary fi­bro­sis, then bring­ing oth­er can­di­dates in fi­bro­sis, in­flam­ma­tion and can­cer in­to the clin­ic. While his pre­vi­ous ex­pe­ri­ence leans on the dis­cov­ery side, Galec­to CEO be­lieves his ex­per­tise in the res­pi­ra­to­ry and fi­bro­sis field shapes him up for the job.

→ In a bizarre saga that’s still play­ing out, Rock­well Med­ical’s board has vot­ed to fire its CEO Robert Chioi­ni. But the CEO swift­ly un­fired him­self, al­leg­ing that board mem­bers may have vi­o­lat­ed fed­er­al se­cu­ri­ties laws by vot­ing him out. That’s be­cause the pur­pose of this par­tic­u­lar meet­ing was to dis­cuss al­le­ga­tions of breach­es of fidu­cia­ry du­ties, not to vote on fir­ing the CEO. “As that ac­tion was not the pur­pose of the spe­cial meet­ing, the ter­mi­na­tion of the CEO, in the opin­ion of the non-con­flict­ed in­de­pen­dent di­rec­tors, was not ef­fec­tive,” writes Chioi­ni in a let­ter to share­hold­ers. If that wasn’t enough, Rock­well Med­ical al­so fired its CFO Thomas Kle­ma, who they said was col­lud­ing with the CEO. But that’s OK, be­cause Chioi­ni al­so re­ject­ed that de­ci­sion, un­fir­ing Kle­ma short­ly af­ter via a let­ter to share­hold­ers.

→ In con­junc­tion with a $18.9 mil­lion round co-led by Ver­sant, La­va Ther­a­peu­tics has an­nounced the ap­point­ment of Paul Par­ren as ex­ec­u­tive vice pres­i­dent and head of R&D. He’s prob­a­bly best known for his time at Gen­mab, where he’s spent 16 years as head of pre­clin­i­cal de­vel­op­ment and re­search. When asked what was be­hind his move to a small start­up, Par­ren said he was up for the chal­lenge of ear­ly-stage re­search. At Nether­lands-based La­va, he will lead the de­vel­op­ment of a type of bi-spe­cif­ic an­ti­bod­ies built on a gam­ma delta T cell plat­form.

Swift Bio­sciences — a provider of li­brary prep so­lu­tions for genome se­quenc­ing — is fol­low­ing a flur­ry of ex­pan­sion ac­tiv­i­ties up with the ap­point­ment of a new CEO. Nathan Wood ar­rives just as the com­pa­ny set­tles in­to its first West Coast of­fice in San Fran­cis­co and pre­pares to move in­to brand new head­quar­ters in Ann Ar­bor. A for­mer pres­i­dent of syn­thet­ic ge­nomics com­pa­ny SGI-DNA, Wood is ex­pect­ed to ex­tend Swift’s reach to what they see as a grow­ing group of cus­tomers in need of next-gen se­quenc­ing for dis­cov­ery, re­search and analy­sis.

→ Drawn to Trans­late Bio’s mR­NA plat­form, long­time health­care in­vestor and for­mer Al­lianz an­a­lyst John Schroer is mak­ing the jump to biotech and tak­ing up a CFO role. The young biotech be­lieves its plat­form, which tar­gets pro­tein pro­duc­tion, can be ap­plied to a broad range of dis­eases; it’s start­ing out with a clin­ic-ready pro­gram in cys­tic fi­bro­sis and an­oth­er pre­clin­i­cal drug for or­nithine tran­scar­bamy­lase de­fi­cien­cy.

→ Still reel­ing from a cru­cial Phase IIb fail­ure that dragged its stock down two months ago, Pro­tag­o­nist Ther­a­peu­tics $PT­GX has brought in Jazz Phar­ma found­ing CEO Samuel Saks to of­fer strate­gic over­sight of its pipeline. In the new­ly cre­at­ed role of chief de­vel­op­ment of­fi­cer — a po­si­tion he’s pre­vi­ous­ly tak­en up at Aus­pex Phar­ma — Saks is tasked with help­ing “re­al­ize the full po­ten­tial” of Pro­tag­o­nist’s pep­tide-based drugs by ad­vis­ing on re­search and clin­i­cal pro­grams.

→ Af­ter a clin­i­cal strat­e­gy stint at Roivant Sci­ences (pre­ced­ed by an­oth­er at Ax­o­vant), Mark Demi­track is join­ing Treve­na $TRVN as CMO. It’s a role that he’s well fa­mil­iar with, giv­en his 13-year tenure at med­ical de­vice com­pa­ny Neu­ro­net­ics. While the Chester­brook, PA-based biotech is fo­cused on pain treat­ment at the mo­ment — with an NDA for oliceri­dine in­jec­tion un­der re­view — Demi­track will be re­spon­si­ble for more than just ap­proval and post-ap­proval ac­tiv­i­ties. Chan­nel­ing his ex­pe­ri­ence at Lil­ly Re­search Labs, he will be ex­pect­ed to shep­herd Treve­na’s oth­er as­sets, in­clud­ing a treat­ment for se­vere mi­graine, from ear­ly de­vel­op­ment through com­mer­cial­iza­tion.

→ In prepa­ra­tion for the de­par­ture of CMO David Tuck, can­cer biotech Curis $CRIS has ap­point­ed Robert Martell as its first head of R&D. Martell, who’s fa­mil­iar­ized him­self with the com­pa­ny and its lead drug for dif­fuse large B-cell lym­phoma as a board mem­ber for the past few years, is now charged with putting the drug — dubbed fimepino­s­tat — on a path to reg­is­tra­tion. Martell pre­vi­ous­ly worked as CMO of Tesaro and is an ex-staffer of Bris­tol My­ers Squibb’s on­col­o­gy unit. Tuck is re­turn­ing to aca­d­e­m­ic re­search af­ter bring­ing sev­er­al of Curis’ can­di­dates in­to the clin­ic.

→ Look­ing to es­tab­lish it­self in the mar­ket for trans­la­tion­al re­search ser­vices, An­aBios has hired sea­soned ex­ec Chris Math­es as chief com­mer­cial of­fi­cer. Math­es jumps the same role at Ica­gen, which, like An­aBios, op­er­ates an ear­ly drug dis­cov­ery plat­form. Man­ag­ing the ex­ter­nal-fac­ing side of the com­pa­ny, Math­es will ex­plore busi­ness op­por­tu­ni­ties and head up strat­e­gy for its “de-risk­ing tech­nol­o­gy.”

→ On the cusp of com­mer­cial­iza­tion of its first re­gen­er­a­tive med­i­cine prod­uct, Po­lar­i­tyTE $COOL has re­cruit­ed Howard Hech­ler from med­ical equip­ment man­u­fac­tur­ing Smith & Nephew to be its chief busi­ness of­fi­cer. Hech­ler’s broad man­date spans M&A, part­ner­ing ef­forts, and align­ment of pipeline de­vel­op­ment with com­mer­cial pri­or­i­ties.

→ Re­peat en­tre­pre­neur and car­di­ol­o­gist Mar­tin Roth­man is the newest ven­ture part­ner at Sofinno­va Part­ners, the Eu­ro­pean VC firm that in­vest­ed in a com­pa­ny he found­ed called Lim­Flow. For his first for­ay in­to in­vest­ing, Roth­man will iden­ti­fy and eval­u­ate the type of com­pa­nies that he knows best: med­ical de­vice. Be­fore join­ing Sofinno­va, which closed a $340 crossover fund just weeks ago, Roth­man served as the VP of med­ical af­fairs for coro­nary, struc­tur­al heart and re­nal den­er­va­tion at med­ical de­vice gi­ant Medtron­ic.

Ar­Qule $AR­QL has en­list­ed two more ex­ecs on its quest to de­vel­op on­col­o­gy and rare dis­ease meds for bio­mark­er-de­fined pa­tient pop­u­la­tions. Marc Schegerin comes in as SVP, cor­po­rate strat­e­gy, com­mu­ni­ca­tion and fi­nance, while Shirish Hi­rani will be SVP, pro­gram man­age­ment and prod­uct plan­ning. Schegerin has split his time in bio­phar­ma be­tween in­vest­ment bank­ing and strat­e­gy roles in biotech, start­ing off at Gold­man Sachs, tak­ing stints at Bio­gen and Sage Ther­a­peu­tics be­fore land­ing at Cit­i­group most re­cent­ly. Hi­rani, on the oth­er hand, has a re­sume lined with biotechs like Dyax and Gen­zyme, topped with a drug de­vel­op­ment role at Take­da-ac­quired Ari­ad Phar­ma.

→ For­mer Deutsche Bank and UBS an­a­lyst An­drew Pe­ters is the new (and first) VP of strat­e­gy at Ex­elix­is $EX­EL. Pe­ters’ ar­rival comes on the heels of a dam­ag­ing tri­al read­out that sug­gest­ed Ex­elix­is’ MEK in­hibitor Cotel­lic wasn’t any good at boost­ing Roche’s Tecen­triq in im­prov­ing over­all sur­vival for colon can­cer pa­tients, as many an­a­lysts ex­pect­ed it would. As the South San Fran­cis­co biotech maps a path for­ward, Pe­ters will as­sist the lead­er­ship team in re­fin­ing the mid- to long-term strat­e­gy.

→ Look­ing to beef up its pipeline of both in-house and li­cens­able as­sets, San Car­los, CA-based Apex­i­gen has tapped Frances Re­na Bah­jat to steer fur­ther dis­cov­ery and pre­clin­i­cal de­vel­op­ment of im­muno-on­col­o­gy as­sets based on its plat­form tech. Bah­jat jumps to this VP of dis­cov­ery re­search role from Bris­tol My­ers Squibb, which hap­pens to be part­nered with Apex­i­gen on a com­bo fea­tur­ing Op­di­vo and APX005M. She will al­so sup­port the de­vel­op­ment of the PhII drug.

→ With a string of CRO ex­ec roles un­der his belt, Pe­te Ni­eto has been named VP of busi­ness de­vel­op­ment at Pro­Scien­to, scout­ing op­por­tu­ni­ties for the San Diego-based com­pa­ny as it ex­pands its pres­ence over­seas but re­mains fo­cused on NASH, di­a­betes, obe­si­ty and re­lat­ed meta­bol­ic dis­eases. He joins from PPD.

→ An­ti­body dis­cov­ery com­pa­ny Im­muno­Pre­cise has hired Mi­crosoft vet Charles Whee­lock as chief tech­nol­o­gy of­fi­cer and Kari Graber as di­rec­tor of glob­al client ser­vices and project man­age­ment. Co­or­di­nat­ing their work will be CEO Jen­nifer Bath, who was con­cur­rent­ly in­duct­ed to the board of di­rec­tors.

Fran­cois Nad­er has tak­en a board seat at New York City-based Pre­vail Ther­a­peu­tics as the biotech ush­ers its gene ther­a­py pro­grams for Parkin­son’s and oth­er neu­rode­gen­er­a­tive dis­eases in­to the clin­ic. Nad­er is prob­a­bly best known for his tenure at NPS Phar­ma, which cul­mi­nat­ed in a $5.2 bil­lion ac­qui­si­tion by Shire.

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D re­or­ga­ni­za­tion in­side Sanofi is con­tin­u­ing, more than a year af­ter the phar­ma gi­ant brought in John Reed to head the re­search arm of the Paris-based com­pa­ny.

Sanofi said in a state­ment that it is cut­ting its re­search ranks by 466 in France and Ger­many while drop­ping new, in-house car­di­ol­o­gy drug re­search. Ex­ist­ing car­dio pro­grams will go for­ward, says Sanofi, but the pipeline is be­ing cut off at the dis­cov­ery source. The phar­ma gi­ant, long known as a lag­gard in R&D, in­tends to com­mit more of its re­sources to the 4 re­main­ing R&D fo­cus­es: can­cer, im­munol­o­gy, rare dis­eases and vac­cines.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

UP­DAT­ED: Chica­go biotech ar­gues blue­bird, Third Rock 'killed' its ri­val, pi­o­neer­ing tha­lassemia gene ther­a­py in law­suit

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

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In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.