Mer­ck dou­bles down on Mod­er­na's mR­NA can­cer vac­cines, pay­ing $125M to part­ner on KRAS shared anti­gen strat­e­gy

Mer­ck and its R&D chief Roger Perl­mut­ter are bet­ting big on their re­la­tion­ship with Mod­er­na, pay­ing $125 mil­lion for a chunk of Se­ries H eq­ui­ty in the mes­sen­ger RNA pi­o­neer as they add a ma­jor col­lab­o­ra­tion on an off-the-shelf ap­proach to can­cers with KRAS mu­ta­tions.

Roger Perl­mut­ter

In an in­ter­view pre­view­ing the an­nounce­ment, CEO Stephane Ban­cel and can­cer re­search chief Tal Zaks not­ed that Mer­ck plans to test this in com­bi­na­tion with Keytru­da, its star check­point in­hibitor, which has faced a tough chal­lenge in KRAS.

Their shared anti­gen can­cer vac­cine, mR­NA-5671, en­codes for four of the most com­mon kind of KRAS mu­ta­tions — a well known dri­ver for large seg­ments of pa­tients suf­fer­ing from non-small cell lung can­cer, col­orec­tal can­cer and pan­cre­at­ic can­cer. KRAS mu­ta­tions can serve as tu­mor re­jec­tion epi­topes, the biotech ex­plains, which can spark an im­mune re­sponse — a strat­e­gy that would have ob­vi­ous util­i­ty as a com­pan­ion to a check­point on hard-to-hit tar­gets.

As a prime tar­get in on­col­o­gy, it’s al­so worth not­ing that KRAS has been one of the tough­est tar­gets in can­cer R&D.

While Mer­ck is a busy play­er in­volved in hun­dreds of part­ner­ships, it’s fair­ly un­usu­al for the phar­ma gi­ant to un­der­take the proof-of-con­cept work it­self, let alone make a sub­stan­tial buy-in like this. Un­der the agree­ment, there are shared costs for the pro­gram along with a split on any prof­its that might lie ahead.

Tal Zaks

Up to now Mod­er­na and Mer­ck, which ini­tial­ly paid $200 mil­lion to part­ner with the biotech on can­cer, have fo­cused on per­son­al­ized can­cer vac­cines that are cus­tomized for each pa­tient. The shared anti­gen ap­proach has been tried at least once by ri­val Cure­Vac — on prostate can­cer — un­suc­cess­ful­ly. But Zaks says he’s not dis­cour­aged by any oth­er set­backs.

“We took it through its pre­clin­i­cal paces last year,” says Zaks about mR­NA-5671. They’ve seen how it could work in one pa­tient, in ad­di­tion to their lab work. And he of­fers their tech plat­form and the ad­di­tion of Keytru­da as added rea­sons for con­fi­dence.

“Mer­ck has a very high bar on the sci­ence,” notes Ban­cel. “This is get­ting them to want to do more.”

Mod­er­na has been build­ing an ear­ly-stage pipeline for mR­NA that has at­tract­ed some avid back­ers like Mer­ck and more than its share of flak by a cho­rus of doubters. On­ly some sol­id hu­man da­ta is go­ing to set­tle that de­bate — and now they’re on track for get­ting it.

In the mean­time, most Mod­er­na watch­ers are wait­ing to see when the pri­vate uni­corn biotech with its $7 bil­lion to $7.5 bil­lion val­u­a­tion will shoot for an IPO. I’m no clos­er in find­ing out what the time­line is there, but I’ll keep ask­ing the ques­tion.

Im­age: Stephane Ban­cel, YouTube

Zo­genix plans quick re­turn to the FDA with their spurned ap­pli­ca­tion on Dravet syn­drome drug — shares spike

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.