NewLink grabs the AACR spot­light with IDO path­way, Keytru­da com­bo -- shares blitzed

At­ten­dees, speak­ers and awardees dur­ing AACR’s 2017 Open­ing Cer­e­mo­ny © AACR/Todd Buchanan 2017

WASH­ING­TON, DC — Re­searchers at NewLink Ge­net­ics are in the spot­light at AACR this morn­ing with da­ta show­ing that their pair-up of the biotech’s IDO path­way in­hibitor in­dox­i­mod with Mer­ck’s Keytru­da sig­nif­i­cant­ly pushed up re­sponse rates over what the PD-1 check­point alone nor­mal­ly pro­duces for ad­vanced melanoma.

The his­tor­i­cal per­cent­age re­sponse rate for Keytru­da alone in this field is in the low 30s, but for all the 60 evalu­able pa­tients in the study the ORR was 52% — in­clud­ing hard-to-tread oc­u­lar melanoma cas­es. If you leave out the oc­u­lar (eye) pa­tients, the suc­cess ra­tio ris­es to 59%, with a dis­ease con­trol rate of 80%. And the re­searchers say the safe­ty pro­file for the com­bo looked sim­i­lar to Keytru­da alone, which will help the biotech start mak­ing the case that it can add a ther­a­py to a check­point with­out push­ing tox­i­c­i­ty, the way a CT­LA-4 drug like Yer­voy would.

A group of crit­ics on Twit­ter hit the da­ta quick­ly Tues­day morn­ing, though, ques­tion­ing the re­sults and dri­ving the stock down 22% in ear­ly trad­ing.

NewLink $NLNK is un­usu­al in this field. The biotech — which was ham­mered in 2016 with the fail­ure of its pan­cre­at­ic can­cer vac­cine — part­nered with Genen­tech in 2014 on GDC-0919, a spe­cif­ic IDO en­zy­mat­ic in­hibitor. Genen­tech has that pro­gram un­der its wing af­ter pay­ing $150 mil­lion up­front with more than a bil­lion dol­lars promised in mile­stones.

Charles Link

NewLink CEO Chuck Link de­scribes in­dox­i­mod as its whol­ly-owned IDO path­way in­hibitor, sep­a­rate from the en­zy­mat­ic spe­cif­ic group, which in­cludes In­cyte’s lead­ing epaca­do­stat, now head­ed in­to a full slate of late-stage com­bi­na­tions with Keytru­da (Mer­ck) and Op­di­vo (Bris­tol-My­ers).

“In­dox­i­mod is a drug we’re try­ing to ful­ly un­der­stand,” Link tells me. The drug acts on both den­drit­ic cells and T cells, he says, al­low­ing the T cells to repli­cate in fight­ing can­cer. It does not bind with the kind of speci­fici­ty that char­ac­ter­izes the en­zy­mat­ic class.

The next step is to push ahead in­to a reg­is­tra­tion study. The lat­est da­ta comes from a Phase II that does not have a con­trol arm, which will be reme­died in the late-stage tri­al. And Link says he ex­pects the study to get un­der­way lat­er this year.

Link wasn’t ready to pro­vide an es­ti­mate of when the da­ta will read out. That might de­pend on a va­ri­ety of things, he says, in­clud­ing some de­sign el­e­ments that might al­low for an ear­ly cut of the re­sults that could be tak­en to the FDA in search of an ac­cel­er­at­ed ap­proval.

Time will tell.

IDO in­hi­bi­tion came in­to full fo­cus dur­ing the last few days as In­cyte surged on its late-stage de­vel­op­ment plans. Be­hind the lead­ers you’ll find a host of ear­ly-stage ef­forts un­der­way, and Link be­lieves that there may be a fu­ture for com­bin­ing IDO path­way and IDO en­zyme in­hibitors.

What In­cyte, NewLink and all the oth­er play­ers are won­der­ing is if an IDO/PD-1 or IDO/PD-L1 check­point can do as well as a check­point match-up us­ing a CT­LA-4. Those CT­LA-4s are ef­fec­tive, but well known for a harsh tox­i­c­i­ty that makes them hard to tol­er­ate. And that would have ma­jor im­pli­ca­tions not on­ly for Yer­voy’s fu­ture, but al­so com­bos like As­traZeneca’s dur­val­um­ab and treme­li­mum­ab, a CT­LA-4 that oc­cu­pies a cen­tral role in the phar­ma gi­ant’s plans to leap from last place in­to the fore­front, pre­sum­ing they can get a rel­a­tive­ly quick OK as the fifth in a se­ries.

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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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.

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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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.