Num­ber 7? Cel­gene part­ner BeiGene joins the crowd with stel­lar PD-1/L1 da­ta from a piv­otal test

Get ready for the sec­ond wave of PD-1/L1 check­point in­hibitors.

BeiGene $BGNE an­nounced just ahead of the start of the week in Bei­jing that their PD-1 tislelizum­ab — part­nered with Cel­gene $CELG — scored stel­lar da­ta in a small Phase II tri­al for clas­si­cal Hodgkin’s lym­phoma among pa­tients who had ei­ther failed or couldn’t take au­tol­o­gous stem cell trans­plan­ta­tion. This is their first piv­otal tri­al, and it un­der­scores why Cel­gene inked a $1.4 bil­lion deal to buy in­to the drug — which may end up as the 7th new check­point to hit the glob­al mar­ket.

Jane Huang

This is a very fa­mil­iar are­na for the check­point field. Bris­tol-My­ers Squibb’s Op­di­vo gained an ac­cel­er­at­ed ap­proval back in 2016 for cHL — with a 7% rate of CRs — and Mer­ck was close be­hind with an OK a year ago as a 4th line ther­a­py fol­low­ing promis­ing re­sults for Keytru­da.

BeiGene, though, would be first in Chi­na, with a sol­id show­ing un­der­scor­ing their drug’s po­ten­tial.

In this new case their drug hit an ob­jec­tive re­sponse rate of 73%, with a 50% CR, and the me­di­an du­ra­tion of re­sponse — over a 6-month av­er­age fol­low-up — had not been reached. 

The transpa­cif­ic BeiGene plans to hus­tle up an ap­pli­ca­tion in Chi­na while they work with Cel­gene on a late-stage pro­gram that in­cludes tri­als for “non-small cell lung can­cer, he­pa­to­cel­lu­lar car­ci­no­ma, and esophageal squa­mous cell car­ci­no­ma; as well as two glob­al Phase 2 tri­als in pa­tients with pre­vi­ous­ly treat­ed he­pa­to­cel­lu­lar car­ci­no­ma or with R/R ma­ture T-and NK-cell lym­phomas, and an ad­di­tion­al piv­otal Phase 2 tri­al in Chi­na in urothe­lial can­cer.”

That’s not all.

BeiGene al­so an­nounced that af­ter dis­cus­sions with the FDA they’re prep­ping an NDA for the first half of 2019 with plans to pur­sue an ac­cel­er­at­ed ap­proval of their drug zanubru­ti­nib for pa­tients with Walden­ström macroglob­u­line­mia based on their glob­al Phase I study. “A fi­nal de­ter­mi­na­tion to sub­mit the NDA will be made sub­se­quent to the pre-NDA meet­ing with FDA af­ter ob­tain­ing ma­ture da­ta from the study this fall.”

Right now there are 5 PD-1/L1 check­points on the mar­ket. Re­gen­eron $REGN and Sanofi $SNY plan to make that 6. And BeiGene looks well po­si­tioned to hit the 7th spot. As of now, there are still hun­dreds of on­go­ing tri­als, in­clud­ing a mob of com­bo stud­ies, as Mer­ck dukes it out with Bris­tol-My­ers for the top po­si­tion of a grow­ing mega­mar­ket. As of now, Mer­ck looks set to take the lead with a string of suc­cess­es in front­line lung can­cer.

Many of these new check­points are be­ing stud­ied in Chi­na, where a group of deep-pock­et in­vestors have been birthing new bio­phar­ma com­pa­nies look­ing to fill the gap of drug tech that sep­a­rates the boom­ing Asian mar­ket with the West.

But there are al­so more than 150 of these ex­per­i­men­tal PD-1/L1 drugs in the glob­al pipeline, ac­cord­ing to re­search from the Can­cer Re­search In­sti­tute, and even­tu­al­ly the world will ei­ther run out of un­chart­ed on­col­o­gy ter­rain, mar­ket po­ten­tial or pa­tients look­ing to en­roll in a tri­al. Then the new ar­rivals will ei­ther shriv­el or the whole mar­ket will be swift­ly com­modi­tized with mul­ti­ple play­ers.

That line, though, has not yet been reached.

“We are ex­cit­ed to an­nounce the pre­lim­i­nary topline re­sults from our first piv­otal tri­al for tislelizum­ab. De­spite short fol­low-up, we be­lieve there was a demon­stra­tion of ro­bust ac­tiv­i­ty, with high over­all and com­plete re­sponse rates in ad­di­tion to a safe­ty pro­file that is con­sis­tent with oth­er PD-1 in­hibitors. We be­lieve these strong re­sults will sup­port our first reg­u­la­to­ry fil­ing in Chi­na for tislelizum­ab, which is planned for lat­er this year,” com­ment­ed Jane Huang, chief med­ical of­fi­cer, hema­tol­ogy, at BeiGene.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.