Hookipa rais­es $60M to fund im­munother­a­py R&D; Roche bags Io­n­is op­tion for $45M; Re­gen­eron fights back against No­var­tis' Eylea ri­val

→ Hookipa Biotech has raised $60 mil­lion (€50 mil­lion) in an over­sub­scribed Se­ries C round to help push its lead pro­gram, a vac­cine for in­fec­tions caused by a genus of virus­es called cy­tomegalovirus, through Phase II clin­i­cal tri­als. The new round was led by an un­named blue chip U.S. pub­lic in­ven­st­ment fund, and was joined by Gilead as a strate­gic in­vestor. Oth­er new in­vestors in­clude HBM Part­ners, Hill­house Cap­i­tal, and Sirona Cap­i­tal. Hookipa al­ready had sev­er­al ex­ist­ing in­vestors on board in­clud­ing Boehringer In­gel­heim’s ven­ture arm and Take­da Ven­tures, which par­tic­i­pat­ed in the round. Oth­er than the cy­tomegalovirus pro­gram (called HB-101), the Vi­en­na-based com­pa­ny is al­so hop­ing to take its ther­a­py for head and neck squa­mous cell car­ci­no­ma to Phase I tri­als. Hookipa plans to ex­pand its tech plat­form in­to oth­er dis­ease ar­eas, in­clud­ing prostate can­cer.

Io­n­is start­ed the day with the news that its part­ner Roche has ex­er­cised the op­tion to li­cense IO­N­IS-HT­TRx for Hunt­ing­ton’s dis­ease, hand­ing the com­pa­ny $IONS $45 mil­lion in cash. Roche made the de­ci­sion — which makes the gi­ant $RHH­BY re­spon­si­ble for all de­vel­op­ment and com­mer­cial ac­tiv­i­ties of the drug — in light of re­sults from a Phase I/IIa place­bo-con­trolled, dose es­ca­la­tion study. A deal years in the mak­ing, the pact with Roche dates back to 2013, when Io­n­is was still known as Isis. To be sure, HD is not at the top of Io­n­is ex­ecs’ minds, who are busy in bat­tle with their hered­i­tary AT­TR amy­loi­do­sis block­buster con­tender in­ot­ersen. But they didn’t mind tout­ing the da­ta from this deal-seal­ing study, ei­ther: “For the first time, a drug has low­ered the lev­el of the tox­ic dis­ease-caus­ing pro­tein in the ner­vous sys­tem, and the drug was safe and well tol­er­at­ed,” said lead in­ves­ti­ga­tor Sarah Tabrizi in a state­ment.

→ The FDA has ac­cept­ed Re­gen­eron’s ap­pli­ca­tion for a 12-week reg­i­men of wet AMD drug Eylea and set a PDU­FA date for Au­gust 2018. The progress puts the com­pa­ny in a bet­ter po­si­tion to com­pete with No­var­tis’ fast-ap­proach­ing Eylea ri­val RTH258 (brolu­cizum­ab), should the dos­ing sched­ule be ap­proved. No­var­tis $NVS is large­ly bank­ing on RTH258’s 12-week reg­i­men will win over a big slice of the Wet AMD mar­ket, as Re­gen­eron’s flag­ship ther­a­py Eylea is cur­rent­ly an 8-week reg­i­men. There’s a lot at stake, with Re­gen­eron $REGN tak­ing in $953 mil­lion in US Eylea sales in Q3 this year. The news is like­ly a re­lief for Re­gen­eron, which has un­der­gone two back-to-back com­bo tri­al flops with Eylea. Ear­li­er this year, the drug in com­bi­na­tion with nes­vacum­ab failed to beat a so­lo ver­sion of Eylea. And more than a year ago, its an­ti-PDFG an­ti­body rin­u­cum­ab com­bined with Eylea failed a Phase II tri­al for age-re­lat­ed mac­u­lar de­gen­er­a­tion.

→ In an­oth­er at­tempt to run ahead of ri­vals Iron­wood and Syn­er­gy, Arde­lyx an­nounced to­day that it has out-li­censed tena­panor for $12 mil­lion up­front to Shang­hai-based Fo­s­un Phar­ma, which has bought the ex­clu­sive rights to de­vel­op and com­mer­cial­ize the lead prod­uct in Chi­na. Ad­di­tion­al mile­stones to­tal up to $113 mil­lion; the agree­ment al­so cov­ers tiered roy­al­ty pay­ments on net sales rang­ing from the mid-teens to 20%. Where­as the fo­cus is on the hot­ly con­test­ed field of ir­ri­ta­ble bow­el syn­drome with con­sti­pa­tion (IBS-C) and hy­per­phos­phatemia re­lat­ed to chron­ic kid­ney dis­ease, Fo­s­un has al­so ac­quired the rights to com­mer­cial­ize tenepanor for oth­er in­di­ca­tions ap­proved in the US. The Fre­mont, CA-based biotech came out in Oc­to­ber with new PhI­II da­ta that proved more im­pres­sive than the round re­leased in May. Clear­ly, Fo­s­un shared the en­thu­si­asm of US in­vestors. “Tena­panor’s po­ten­tial as a dif­fer­en­ti­at­ed treat­ment for both car­diore­nal and GI dis­eases is im­pres­sive,” said Yi­fang Wu, pres­i­dent and CEO of Fo­s­un’s epony­mous par­ent com­pa­ny. “The da­ta gen­er­at­ed by Arde­lyx to-date gives us con­fi­dence that tena­panor could be a lead­ing treat­ment op­tion for both ther­a­peu­tic ar­eas, of­fer­ing unique ad­van­tages to pa­tients.”

With ad­di­tion­al re­port­ing by Brit­tany Meil­ing.

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.

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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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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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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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.

Dave Barrett, Brian Chee, Amir Nashat, Amy Schulman. Polaris

Bob Langer's first port of call — Po­laris Part­ners — maps $400M for ninth fund

Health and tech ven­ture group Po­laris Part­ners, which counts Alec­tor, Al­ny­lam and Ed­i­tas Med­i­cine as part of its port­fo­lio, is set­ting up its ninth fund, rough­ly two years af­ter it closed Po­laris VI­II with $435 mil­lion in the bank, sur­pass­ing its tar­get by $35 mil­lion.

The Boston-based firm, in an SEC fil­ing, said it in­tends to raise $400 mil­lion for the fund. Po­laris — which rou­tine­ly backs com­pa­nies mold­ed out of the work done in the lab of pro­lif­ic sci­en­tist Bob Langer of MIT  — typ­i­cal­ly in­vests ear­ly, and sticks around till com­pa­nies are in the green. Like its peers at Flag­ship and Third Rock, Po­laris is all about cham­pi­oning the lo­cal biotech scene with a steady flow of start­up cash.

Partners Innovation Fund

David de Graaf now has his $28.5M launch round in place, build­ing a coen­zyme A plat­form in his lat­est start­up

Long­time biotech ex­ec David de Graaf has the cash he needs to set up the pre­clin­i­cal foun­da­tion for his coen­zyme A me­tab­o­lism com­pa­ny Comet. A few high-pro­file in­vestors joined the ven­ture syn­di­cate to sup­ply Comet with $28.5 mil­lion in launch mon­ey — enough to get it two years in­to the plat­form-build­ing game, with­in knock­ing dis­tance of the clin­ic.

Canaan jumped in along­side ex­ist­ing in­vestor Sofinno­va Part­ners to co-lead the round, with par­tic­i­pa­tion by ex­ist­ing in­vestor INKEF Cap­i­tal and new in­vestor BioIn­no­va­tion Cap­i­tal.

A uni­corn stalks Wall Street in search of IPO cash; CASI Phar­ma in-li­cens­es CD19 ther­a­py from Chi­na’s Ju­ven­tas

→ A herd of up­start biotechs will look to Wall Street for some ma­jor wind­falls this week as a burst of new of­fer­ings con­tin­ues to feed cash in­to the R&D sys­tem. To­day we learned that Bridge­Bio will look to raise in the neigh­bor­hood of $225 mil­lion by of­fer­ing 15 mil­lion shares for $14 to $16 each. And they have a string of joint bookrun­ners: J.P. Mor­gan, Gold­man Sachs, Jef­feries, SVB Leerink, KKR, Piper Jaf­fray, Mizuho Se­cu­ri­ties, BMO Cap­i­tal Mar­kets and Ray­mond James. If suc­cess­ful, Bridge­Bio will emerge with a mar­ket cap of around $1.7 bil­lion. There are 5 biotechs look­ing to IPO this week, in­clud­ing Akero and Pre­vail.

Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.