Mer­ck­'s melanoma drug shows ear­ly promise for re­sis­tant can­cers in PhI tri­al

Ear­ly news on a Mer­ck drug can­di­date has re­searchers hope­ful that the in­ves­ti­ga­tion­al ther­a­py could be used to fight drug re­sis­tant can­cers. The da­ta is ear­ly — and on a very small pa­tient group — but re­searchers say the drug’s per­for­mance match­es ini­tial re­sponse rates to ap­proved treat­ments like MEK in­hibitors.

The treat­ment, called MK-8353, was test­ed in pa­tients with melanoma and oth­er can­cers with mu­ta­tions in the BRAF or RAS genes. The drug was de­signed to block the ERK sig­nal, which has been shown to help dri­ve can­cer cell growth in re­sis­tant melanoma and oth­er dis­eases.

While tar­get­ed treat­ments have been ap­proved for melanoma and lung can­cers with a spe­cif­ic mu­ta­tion in the BRAF gene, most pa­tients de­vel­op re­sis­tance to these treat­ments, and their can­cer comes back, most com­mon­ly due to ERK re­ac­ti­va­tion.

To tack­le the re­sis­tance prob­lem, re­searchers at Uni­ver­si­ty of North Car­oli­na Lineberg­er and oth­er in­sti­tu­tions in­ves­ti­gat­ed MK-8353 to block ERK. Re­sults from the Phase I study were pub­lished by UNC Lineberg­er’s Ster­gios Moschos and his col­leagues.

Chan­ning Der

“ERK cer­tain­ly stim­u­lates fac­tors that pro­mote can­cer growth,” Chan­ning Der, a pro­fes­sor at UNC School of Med­i­cine De­part­ment of Phar­ma­col­o­gy, said in a state­ment. “ERK is very com­plex, and it’s still sur­pris­ing­ly poor­ly un­der­stood, but what is very clear is that it is re­quired for can­cer growth, and that’s why there are a num­ber of in­hibitors in this path­way that are ei­ther ap­proved, or un­der clin­i­cal eval­u­a­tion.”

In this new study, three of the 15 pa­tients who had re­sults that could be eval­u­at­ed ex­pe­ri­enced par­tial re­spons­es to the in­ves­ti­ga­tion­al treat­ment. Re­searchers not­ed that al­though their study in­clud­ed a small num­ber of pa­tients, this re­sponse rate was sim­i­lar to rates seen in stud­ies of oth­er treat­ments.

“The re­sponse rate that we saw for ERK in­hibitors is rem­i­nis­cent of the re­sponse seen with MEK in­hibitors,” Moschos said. “We think, there­fore, that ERK in­hibitors can­not be giv­en as sin­gle agents, just like MEK in­hibitors. The ques­tion is: Which com­bi­na­tion is best?”

The UNC tri­al was part of a larg­er ef­fort look­ing at the po­ten­tial of ERK in­hibitors in treat­ing dif­fer­ent can­cers. Mer­ck is cur­rent­ly test­ing MK-8353 along with its im­muno-on­col­o­gy drug Keytru­da in a Phase Ib tri­al re­cruit­ing pa­tients with ad­vanced tu­mors.

Im­age: UNC Lineberg­er’s Ster­gios Moschos. UNC Lineberg­er

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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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. 

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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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.

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.

FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Top an­a­lyst finds a sil­ver lin­ing in Ab­b­Vie’s $63B Al­ler­gan buy­out — but there’s a catch

Af­ter get­ting beat up on all sides from mar­ket ob­servers who don’t much care for the lat­est mega-deal to ar­rive in bio­phar­ma, at least one promi­nent an­a­lyst now is start­ing to like what he sees in the num­bers for Ab­b­Vie/Al­ler­gan.

But it’s go­ing to take some en­cour­age­ment if Ab­b­Vie ex­ecs want it to last.

Ab­b­Vie’s mar­ket cap de­clined $20 bil­lion on Tues­day as the stock took a 17% hit dur­ing the day. And SVB Leerink’s Ge­of­frey Porges can see a dis­tinct out­line of an up­side af­ter re­view­ing the fun­da­men­tals of the deal.

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