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.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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