Nas­daq wraps up Q3 with IPO pitch­es from Gami­da Cell, NGM, Arog to­talling $219M

Nas­daq’s bub­bling biotech week did not just end with Gri­s­tone’s top-of-the-range raise, which brought the IPO tal­ly to $520 mil­lion. Late Fri­day, three more biotechs lined up to en­ter the club, seek­ing a col­lec­tive $219 mil­lion to fu­el mid- and late-stage en­deav­ors on can­cer and NASH.

As we en­ter Q4, it re­mains to be seen whether 2018 — at 49 com­plet­ed deals — will sur­pass the 66 bio­phar­ma IPO record set in 2014. But it is with­in range.

While the year has seen a num­ber of pre­clin­i­cal biotechs reap big wind­fall on their pub­lic de­but, Gami­da Cell, NGM Bio and Arog Phar­ma all have some hu­man da­ta — and for two of them, big name back­ers or part­ners — to show for their pitch­es.

Ju­lian Adams

Biotech vet­er­an Ju­lian Adams made his IPO am­bi­tions clear on his very first day as CEO of Gami­da Cell. For the Jerusalem-based com­pa­ny to go all the way through Phase III, build out man­u­fac­tur­ing and ex­e­cute a planned mar­ket launch of its uni­ver­sal cell graft, he told End­points News last No­vem­ber, they need­ed much more than the sup­port al­ready pro­vid­ed by No­var­tis, Shav­it Cap­i­tal, VMS In­vest­ment Group, the Is­rael Biotech Fund, Clal Biotech­nol­o­gy In­dus­tries and Is­rael Health­Care Ven­tures.

NiCord, their lead prod­uct com­pris­ing a mix of stem cells, prog­en­i­tor cells as well as den­drit­ic cells, is at the very be­gin­ning of a piv­otal Phase III tri­al for pa­tients with blood can­cers. The clin­i­cal team is al­so in­ves­ti­gat­ing the drug’s ef­fec­tive­ness in treat­ing bone mar­row fail­ure dis­or­ders, as an al­ter­na­tive for pa­tients who ex­pe­ri­ence graft re­jec­tion with con­ven­tion­al trans­plant op­tions.

To wrap all that, and for the build­out of their man­u­fac­tur­ing in Kiry­at Gat, Is­rael, Gami­da Cell is seek­ing $69 mil­lion. They plan to list as $GM­DA.

David Wood­house

NGM Bio, mean­while, is ask­ing for $75 mil­lion on the promise of its NASH ther­a­py, which comes with a slate of Phase II da­ta re­port­ed in April 2017, where in­ves­ti­ga­tors re­port­ed a hit for the pri­ma­ry end­point as well as some im­prove­ments in bio­mark­ers.

“NG­M282 is the first agent I’ve test­ed that holds the po­ten­tial to com­plete­ly re­verse steato­sis in as short as 12 weeks of ther­apy,” an Ox­ford re­searcher said at the time.

That tri­al is still on­go­ing, and a Phase IIb is ex­pect­ed to start in ear­ly 2019 un­der the lead­er­ship of new CEO David Wood­house — a for­mer Gold­man Sachs banker who joined the com­pa­ny as CFO in 2015. He’s re­plac­ing William Rieflin, who’s been bumped up to the ex­ec­u­tive chair­man seat. Pres­i­dent Jeff Jonker, mean­while, is on his way out to a new ex­ec­u­tive po­si­tion. We don’t know where.

While ad­vanc­ing its in-house drug, NGM Bio — go­ing by $NGM — has al­so been work­ing close­ly with Mer­ck, which struck a $450 mil­lion re­search deal in 2015 for ac­cess to its growth dif­fer­en­ti­a­tion fac­tor 15 pro­gram. Col­lab­o­ra­tion rev­enue reg­is­tered at $40.7 mil­lion for the first half of 2018.

Scott Sal­ka

Dal­las-based Arog Phar­ma is the youngest of the three, found­ed in 2010 by on­col­o­gist Vinay Jain af­ter he li­censed the lead drug, crenolanib, from Pfiz­er for a cheap up­front li­cense fee “in the low sev­en fig­ures” with reg­u­la­to­ry and com­mer­cial­iza­tion mile­stones to­tal­ing $12.5 mil­lion.

In their fil­ing, the com­pa­ny — now led by ex-Am­bit chief Scott Sal­ka — ex­plains why it is so ex­cit­ed about the drug, which has re­ceived fast track des­ig­na­tion at the FDA as a ther­a­py for acute myeloid leukemia:

The clin­i­cal de­vel­op­ment of crenolanib at Pfiz­er had fo­cused on the in­hi­bi­tion of PDGFR in sol­id tu­mors and had demon­strat­ed fa­vor­able safe­ty and tol­er­a­bil­i­ty in over 100 pa­tients in two clin­i­cal tri­als. Af­ter ob­tain­ing rights to crenolanib, we dis­cov­ered its po­tent ac­tiv­i­ty against FLT3, a now val­i­dat­ed tar­get; such ac­tiv­i­ty against FLT3 was pre­vi­ous­ly un­known. In ad­di­tion, we dis­cov­ered that op­ti­miz­ing the dos­ing sched­ule to three times dai­ly al­lows for greater sus­tained tar­get in­hi­bi­tion, a crit­i­cal at­tribute of ef­fec­tive ty­ro­sine ki­nase in­hibitor, or TKI, ther­a­pies.

If the IPO goes ac­cord­ing to plan, Arog will get a $75 mil­lion in­fu­sion of cash to take this and a sec­ond li­censed pro­gram for­ward un­der the sym­bol $AROG.

Oric CEO Ja­cob Chacko and Dean Fer­rig­no, a for­mer ex­ec at Sor­ren­to, are among the in­sid­ers cur­rent­ly fund­ing the com­pa­ny, though their stakes are not spelled out in the fil­ing.

J&J's Mathai Mammen at an Endpoints News event in Boston, June 2018 (Photo: Rob Tannenbaum for Endpoints News)

J&J fronts $750M cash to grab a failed can­cer drug that’s been re­pur­posed as a pow­er­ful an­ti-in­flam­ma­to­ry

J&J has stepped up with one of its blockbuster drug buys, agreeing to pay Austin-based XBiotech $XBIT $750 million in cash and up to $600 million more in milestones for their late stage-ready anti-inflammatory drug bermekimab — which some longtime biotech observers may recognize as a failed cancer therapy with a disaster-prone past.

The drug targets the IL-1a pathway. J&J $JNJ R&D chief Mathai Mammen is cutting a check for a drug that has produced positive mid-stage data in patients suffering from a skin condition called hidradenitis suppurativa with another mid-stage program underway for atopic dermatitis.

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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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One of Wall Street’s most high-pro­file hedge funds push­es Alex­ion's CEO to the auc­tion block — and he's not budg­ing

Fresh off buying Barnes & Noble and prodding AT&T with some heavy-handed criticism after picking up a $3.2 billion stake in the company, the activist — and supremely high profile — hedge fund Elliott Management has stepped up with some M&A advice for Alexion’s management team.
And the execs on the team $ALXN are giving them a polite — but very firm — stiff arm Friday morning.
In a release out early Friday, the big biotech said that the Elliott team had been in touch to encourage them to sell the company. But that’s not on the agenda.

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Samantha Budd Haeberlein. Biogen via YouTube

UP­DAT­ED: Skep­tics pounce as Bio­gen de­tails pos­i­tive sub­group analy­sis on ad­u­canum­ab — and both sides are dig­ging in

“Exhilarating.” “A major advance.” “A milestone achievement.” If one had just tuned into the panel comments on Biogen’s presentation at CTAD, it would seem that the biotech had an impressive, disease-modifying Alzheimer’s drug in aducanumab.

But off the stage, reactions to their admittedly complicated dataset and the biotech’s explanation for resurrecting a drug that failed its futility analysis were a lot more mixed, with analysts continuing to question whether the evidence is substantial enough to warrant an FDA approval and raising new doubts on the safety side.

In an investor call later in the day, execs noted that they are not planning another study and stood by their intention, publicized in October to much surprise, to submit regulatory filings based on what they have.

“We don’t file willy nilly,” said Al Sandrock, head of R&D. “We only go to filing when we believe that there is a benefit-risk argument based on science, based on data. And if you look at our history, we haven’t done filings right and left without good reason.”

Biogen had a theory going into the Clinical Trials on Alzheimer’s Disease meeting.

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Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

I want to give readers a quick update on the most important part of our business model — premium subscriptions. We have some crucial financial goals we hope to achieve by the end of the year, and the team here in Lawrence is ready to ship some swag to kick off this limited December promotion.

We offer two premium plans — Enterprise for companies ($1,000/year, unlimited people), and Insider for individuals ($200/year). This month of December will be the last chance to enroll at the original rates — which have remained flat since we launched them in 2017.

Jasper Ther­a­peu­tics launch­es out of Stan­ford with new ap­proach to stem cell treat­ment

The first girl in the trial came in with chronic diarrhea and the immune system of an untreated HIV patient. Born with a rare genetic disease that impeded her ability to make B and T cells, she had once been given a stem cell transplant but it didn’t take.  Back in the hospital, she was injected with a new experimental antibody and then given a new stem cell transplant. Soon, she gained weight. The diarrhea stopped.

Ex-Cel­gene ex­ec Ter­rie Cur­ran puts her Phath­om team in place; Car­away taps Mar­tin Williams as CEO

→ Gastrointestinal disease-focused Phathom Pharmaceuticals has shaken up its leadership team. The company has tapped former Celgene exec Terrie Curran as CEO, succeeding David Socks, who is transitioning to interim CFO. Curran was president of Celgene’s global inflammation and immunology franchise — helping with the sale of Otezla for $13.4 billion to Amgen — and has held a previous stint at Merck. In addition to Curran, the company also welcomed former Omeros CMO Eckhard Leifke as CMO, ex-Celgene exec Joseph Hand as chief administrative officer, and former general counsel for Cyclerion Therapeutics Larry Miller as general counsel. They also replaced Chris Slavinsky on the board with Takeda exec Asit Parikh.

UCB buffs up in block­buster pso­ri­a­sis race as bimek­izum­ab beats Hu­mi­ra in head-to-head

Just weeks after boasting head-to-head victories over first placebo and then J&J’s IL-23 contender Stelara in clearing psoriasis, the results are in for UCB’s last Phase III trial, in which bimekizumab went up against the world’s best-selling drug.

Only topline results are provided for today’s readout of the BE SURE study, so we won’t find out just how superior bimekizumab proved against Humira on the co-primary endpoints — standard scores known as PASI90 and IGA measuring the impact and severity of the disease — until a scientific conference in 2020.

With EMA re­view in progress, No­var­tis un­veils more pos­i­tive da­ta on asth­ma ther­a­py

Having made its marketing pitch to the EU regulator, Novartis on Thursday unveiled positive pivotal study data supporting the use of its inhaled asthma treatment.

The therapy, QMF149, consists of the long-acting beta-agonist, or LABA, called indacaterol acetate and the corticosteroid mometasone furoate. In the 2,216-patient, 52-week PALLADIUM study, asthma patients either received a medium or high dose of the Novartis therapy (150/160 μg; 150/320 μg) or mometasone furoate (MF) alone.