Bris­tol-My­ers Squib­b's Op­di­vo/Yer­voy com­bo scores col­orec­tal can­cer OK; For­mer Ake­bia, Mer­ri­mack staffers found guilty

→ Bol­stered by pri­or­i­ty re­view and a break­through ther­a­py des­ig­na­tion, Bris­tol-My­ers Squibb’s Op­di­vo/Yer­voy has been ap­proved for a sub­set of col­orec­tal can­cer pa­tients who’ve run out of op­tions. The FDA gave the green light — cov­er­ing mi­crosatel­lite in­sta­bil­i­ty high (MSI-H) or mis­match re­pair de­fi­cient (dMMR) metasta­t­ic col­orec­tal can­cer (mCRC) that has pro­gressed fol­low­ing treat­ment with a flu­o­ropy­rim­i­dine, ox­ali­platin and irinote­can com­bo — based on an on­go­ing Phase II tri­al. Eighty two out of 119 pa­tients re­ceived treat­ment pri­or to the Check­mate-142 study; 46% in that sub-pop­u­la­tion, and 49% over­all, re­spond­ed to the I/O com­bo. Se­ri­ous ad­verse re­ac­tions oc­curred in 47% of all pa­tients — some­what re­flect­ed in the list of safe­ty warn­ings that come with the ap­proval. The rec­om­mend­ed dos­ing sched­ule in­volves an IV in­fu­sion every three weeks for four dos­es, fol­lowed by Op­di­vo main­te­nance ther­a­py.

→ More than a year af­ter two friends charged with in­sid­er trad­ing by swap­ping non­pub­lic in­fo on their re­spec­tive biotech com­pa­nies, the ver­dict is in: guilty — for con­spir­a­cy and se­cu­ri­ties fraud. Schultz Chan, who worked for Ake­bia Ther­a­peu­tics $AK­BA at the time, and Songjiang Wang, a for­mer Mer­ri­mack Phar­ma­ceu­ti­cals $MACK staffer, re­ceived the ver­dict from a ju­ry in Boston fol­low­ing a two-week tri­al.

Ac­cord­ing to a crim­i­nal com­plaint, the duo were work­ing a two-way deal where Chan — then Ake­bia’s di­rec­tor of bio­sta­tis­tics — fed in­sid­er in­fo on Ake­bia’s tri­al da­ta to Wang, the di­rec­tor of sta­tis­ti­cal pro­gram­ming at Mer­ri­mack, who rec­i­p­ro­cat­ed with the scoop on Mer­ri­mack drugs. One of the deals al­leged­ly yield­ed a $288,000 prof­it.

Both men, who have de­nied wrong­do­ing in the past and de­clined to com­ment af­ter the tri­al, are sched­uled to be sen­tenced in ear­ly Oc­to­ber.

Paula Soteropou­los, Akcea CEO

Akcea $AK­CA has scored its first drug ap­proval since spin­ning out of Io­n­is $IONS, as Eu­ro­pean reg­u­la­tors come through with an ap­proval for in­ot­ersen fol­low­ing a thumbs up from the EMA com­mit­tee. To be mar­ket­ed as Tegse­di, the drug treats hered­i­tary TTR amy­loi­do­sis by block­ing pro­duc­tion of the transthyretin (TTR) pro­tein. The green light gives Io­n­is and the ma­jor­i­ty-owned Akcea an im­por­tant leg up against ri­val Al­ny­lam, whose patisir­an has a US PDU­FA date that’s two months ahead of in­ot­ersen’s in Oc­to­ber. “With the EC’s de­ci­sion, TEGSE­DI is now the world’s first and on­ly RNA-tar­get­ed ther­a­peu­tic ap­proved for pa­tients with hAT­TR amy­loi­do­sis,” said Akcea CEO Paula Soteropou­los. “We are ready to launch Tegse­di along with our pa­tient and physi­cian sup­port ser­vices across Eu­rope.”

→ The res­pi­ra­to­ry ex­perts at As­traZeneca are wad­ing in­to gene ther­a­py for a nov­el ap­proach to treat­ing chron­ic lung dis­ease with a new col­lab­o­ra­tion. Emeryville, CA-based 4D Mol­e­c­u­lar Ther­a­peu­tics will con­tribute its dis­cov­ery plat­form to help iden­ti­fy and en­gi­neer the AAV vec­tor that will be best suit­ed to de­liv­er the drug the part­ners will de­vel­op to­geth­er. Med­Im­mune, the bi­o­log­ics arm of the UK phar­ma gi­ant, has com­mit­ted to play­ing a role in the whole process — from ear­ly stage de­vel­op­ment to com­mer­cial­iza­tion (which 4DMT will pre­sum­ably be in­volved in). Fi­nan­cial de­tails were not dis­closed.

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.

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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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.

Step­ping on Roche's toes, Mer­ck cuts in­to SCLC niche with third-line Keytru­da OK

In the in­creas­ing­ly crowd­ed check­point race, small cell lung can­cer has been a rare area where Roche, a sec­ond run­ner-up, has a lead over the en­trenched lead­ers Mer­ck and Bris­tol-My­ers Squibb. But Mer­ck is fi­nal­ly mak­ing some head­way in that di­rec­tion with the lat­est ap­proval for its PD-1 star.

The lat­est green light en­dors­es Keytru­da in the third-line treat­ment of metasta­t­ic SCLC, where it would be giv­en to pa­tients whose dis­ease ei­ther don’t re­spond to or re­lapse af­ter chemother­a­py, which would have fol­lowed at least one pri­or line of ther­a­py.

Sanofi aligns it­self with Google to stream­line drug de­vel­op­ment

Tech­nol­o­gy is bleed­ing in­to health­care, and big phar­ma is rid­ing the wave. Sanofi $SNY ap­point­ed its first chief dig­i­tal of­fi­cer this Feb­ru­ary, fol­low­ing the foot­steps of its peers. By May, the French drug­mak­er and some of its big phar­ma com­pa­tri­ots joined forces with Google par­ent Al­pha­bet’s Ver­i­ly unit to aug­ment clin­i­cal tri­al re­search. On Tues­day, the Parisian com­pa­ny tied up with Google to ac­cess its cloud com­put­ing and ar­ti­fi­cial in­tel­li­gence tech to spur the de­vel­op­ment of new ther­a­pies.