With help from J&J, up­start Proven­tion lands rights to two mid-stage IBD drugs and shoots for PhII

Af­ter set­ting up one biotech com­pa­ny with a drug plucked from the shelves of big phar­ma, the same team is do­ing it again.

Proven­tion Bio ex­ecs — who un­veiled a $28.4 mil­lion round just a few months ago that in­clud­ed a sig­nif­i­cant con­tri­bu­tion from J&J — are un­veil­ing a new deal with the phar­ma gi­ant to­day, bag­ging rights to a pair of mid-stage as­sets they plan to hus­tle in­to mid-stage stud­ies de­signed to il­lus­trate quick­ly whether they have some­thing that can be point­ed to a piv­otal study.

Ash­leigh Palmer

Proven­tion Bio is run by three key ex­ecs: CEO Ash­leigh Palmer, CMO Eleanor Ramos and sci­en­tif­ic co-founder Fran­cis­co Leon. Palmer and Leon had al­ready set up Ce­lim­mune, which is de­vot­ed to ad­vanc­ing a new drug for Celi­ac dis­ease, which they got from Am­gen. And Leon, a for­mer re­searcher at J&J, has di­rect ex­pe­ri­ence with the two drugs they’re pick­ing up from J&J for their new com­pa­ny.

The drugs are PRV-6527 (JNJ-40346527), an oral Colony Stim­u­lat­ing Fac­tor-1 Re­cep­tor (CSF-1R) small mol­e­cule in­hibitor for Crohn’s dis­ease, and PRV-300 (JNJ-42915925/CN­TO 3157), an an­ti-Toll-Like Re­cep­tor 3 (TLR3) mon­o­clon­al an­ti­body for ul­cer­a­tive col­i­tis. The CSF-1R drug has al­ready been in hu­man stud­ies, in­clud­ing a failed mid-stage study for rheuma­toid arthri­tis.

But Leon be­lieves there’s a “good chance of repo­si­tion­ing (PRV-6527) in IBD; there’s no oral drug for mod­er­ate and se­vere Crohn’s.” And he can count on what re­searchers learned from Ste­lara as well as hu­man and an­i­mal da­ta to pro­vide enough en­cour­age­ment to back up the move back to the clin­ic.

The mod­el that Proven­tion is fol­low­ing strikes a fa­mil­iar cord. A whole new wave of com­pa­nies is be­ing cre­at­ed from the dis­cards at Big Phar­ma. Vivek Ra­maswamy has turned it in­to an art form at Roivant, which has been rais­ing big mon­ey to back more of these deals, while Bio­haven was able to jump from ear­ly-stage re­search straight to late-stage by ex­e­cut­ing a deal with Bris­tol-My­ers Squibb — al­low­ing them to pull off a quick IPO.

In their ear­li­er re­lease on the fundrais­ing, which in­clud­ed $6 mil­lion from J&J, $19 mil­lion from high net worth in­di­vid­u­als and $3 mil­lion from the JDRF, the group men­tioned they were look­ing to an IPO next year to pro­vide con­tin­ued fund­ing. But when I talked to Palmer ahead of to­day’s an­nounce­ment, he said they’re fo­cus­ing on these two as­sets — plus an en­terovirus vac­cine they got in ear­ly — and will de­cide next steps on fi­nanc­ing af­ter they see some hard da­ta.

Proven­tion won’t be spend­ing a ton of mon­ey on salaries or of­fices. The three key ex­ecs are part of a 6-mem­ber vir­tu­al team, which won’t get much big­ger, says Palmer. Not on­ly is the team small, but they’re scat­tered around the coun­try, meet­ing in the vir­tu­al of­fice as they use con­trac­tors on man­u­fac­tur­ing and re­search.

“I’ve been de­vel­op­ing drugs for 20 years,” says Ramos. “The cost of drug de­vel­op­ment is sky­rock­et­ing.” But the Proven­tion team be­lieves they can pull off two small, blend­ed Phase I/II stud­ies that can tell them if they’re on the right track.

Then they can make their go/no go de­ci­sion.

Right now, the light is green.

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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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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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.

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.

Image: Chris Varma. Frontier

UP­DAT­ED: Chris Var­ma un­veils MP­M's lat­est start­up — eye­ing 'un­drug­gable' can­cer tar­gets and pow­ered by ma­chine learn­ing, $67M

Two years af­ter MPM Cap­i­tal en­list­ed Chris Var­ma on its busy on­col­o­gy team, the for­mer en­tre­pre­neur-in-res­i­dence is un­veil­ing his first ven­ture project out of his new stomp­ing grounds in the Bay Area: Fron­tier Med­i­cines.

For Var­ma, who’s al­so co-found­ed Blue­print Med­i­cines and built com­pa­nies at Third Rock and Flag­ship, this marks an­oth­er op­por­tu­ni­ty to ap­ply some cut­ting-edge sci­ence to “sev­er­al of the most im­por­tant and dif­fi­cult tar­gets in can­cer” — tar­gets that oth­ers have tried to tack­le with more clas­si­cal meth­ods and failed. The launch round comes in at $67 mil­lion, which should go some way in scaf­fold­ing a pre­clin­i­cal pipeline and push one or more as­sets in­to the clin­ic three years from now, he tells me.

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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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. 

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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