A sec­ond wave of check­point in­hibitors is swelling fast, with speedy BeiGene leap­ing in­to a piv­otal tri­al

Every­body wants their own check­point in­hibitor, or so it may seem.

Now that the bi­ol­o­gy is thor­ough­ly un­der­stood, we’re see­ing a sec­ond wave of late-stage pro­grams tak­ing shape — each with their own niche mar­kets in mind for dis­rup­tion.

To­day, you can add Bei­jing-based Beigene $BGNE to that list.

The biotech dosed their first pa­tient with re­frac­to­ry clas­si­cal Hodgkin lym­phoma — or cHL — with their an­ti-PD-1 drug BGB-A317 in a piv­otal study.

Beigene’s goal here is to use a Phase II tri­al to push through the first PD-1 check­point ap­proval in Chi­na, which has seen a groundswell of R&D at a grow­ing slate of biotech up­starts. Their pri­ma­ry goal is the over­all re­sponse rate, with sec­on­daries on pro­gres­sion-free sur­vival, du­ra­tion of re­sponse, com­plete re­sponse rate, time to re­sponse, safe­ty, and tol­er­a­bil­i­ty un­der the guid­ance of lead in­ves­ti­ga­tor Pro­fes­sor Jun Zhu of the Peking Uni­ver­si­ty Can­cer Hos­pi­tal.

BeiGene, which is al­so de­vel­op­ing a PARP and a BTK in­hibitor, is all about speed. Their Phase I PD-1 check­point tri­al start­ed less then four months ago, and will be re­viewed at AS­CO in ear­ly June.

“We are pur­su­ing the ap­proval of our PD-1 an­ti­body for pa­tients with re­lapsed or re­frac­to­ry Hodgkin lym­phoma in Chi­na be­cause of the ur­gent un­met med­ical need and sig­nif­i­cant ac­tiv­i­ty ob­served with this class of agents in this set­ting,” com­ment­ed Jane E. Huang, Chief Med­ical Of­fi­cer, Hema­tol­ogy.

And BeiGene isn’t lim­it­ing its fo­cus on Chi­na. They plan to broad­en ap­provals be­yond Chi­na’s bound­aries as they ex­pand their ge­o­graph­ic fo­cus.

Up to now, the ini­tial tar­get of the check­point crowd has been the US. Bris­tol-My­ers, Mer­ck, Roche/Genen­tech, Pfiz­er/Mer­ck KGaA — and prob­a­bly soon As­traZeneca — have all been pil­ing in. The check­points, which take the brakes off an im­mune sys­tem at­tack on can­cer cells, make ide­al com­bo part­ners, so we’re see­ing hun­dreds of clin­i­cal tri­als fo­cused on new dou­bles and triples.

The sec­ond wave of check­points in­cludes pro­grams at In­cyte $IN­CY, which has a lead IDO1 drug in un­ex­clu­sive late-stage part­ner­ships with Bris­tol-My­ers and Mer­ck. Agenus $AGEN start­ed a Phase I/II of their lead check­point — AGEN2034 — a few days ago, look­ing to dou­ble down on a PD-1/CT­LA-4 strat­e­gy. TG Ther­a­peu­tics has an­oth­er.

And so on.

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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Top an­a­lyst of­fers a rare, up­beat in­ter­pre­ta­tion of Ab­b­Vie’s $63B Al­ler­gan deal — 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 at 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.

While Ako­rn works to re­vive its for­tunes, the FDA hits it with an­oth­er warn­ing let­ter

Ako­rn just can’t dig it­self out of its hole.

The spe­cial­ty gener­ic drug­mak­er has re­ceived yet an­oth­er warn­ing let­ter from the FDA this year. With­out dis­clos­ing any specifics, the Lake For­est, Illi­nois-based drug­mak­er on Wednes­day said the US reg­u­la­tor had is­sued the let­ter, cit­ing an in­spec­tion of its Som­er­set, New Jer­sey man­u­fac­tur­ing fa­cil­i­ty in Ju­ly and Au­gust of 2018. The com­pa­ny’s shares $AKRX dipped about 1.7% to $4.65 be­fore the bell.

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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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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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.

Suf­fer­ing No­var­tis part­ner Cona­tus grabs the ax and packs it in on NASH af­ter a se­ries of set­backs

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.