Eli Lil­ly of­fers $400M-plus deal to bag an ear­ly-stage au­toim­mune drug from Nek­tar

With lit­tle more than pre­clin­i­cal da­ta and some ini­tial dos­ing co­hort in­sights avail­able for re­view, Eli Lil­ly is mak­ing a $400 mil­lion-plus play to buy in­to an ear­ly-stage au­toim­mune drug at Nek­tar $NK­TR that the phar­ma gi­ant be­lieves has megablock­buster po­ten­tial.

Dave Ricks, Eli Lil­ly CEO

Eli Lil­ly $LLY has agreed to ac­quire co-de­vel­op­ment rights on NK­TR-358 — which was first dosed in a hu­man in a Phase I study 4 months ago — for $150 mil­lion up front plus $250 mil­lion in mile­stones. Lil­ly will pick up 75% of the Phase II de­vel­op­ment costs and Nek­tar will have the opt-in rights on this drug on an in­di­ca­tion-by-in­di­ca­tion ba­sis.

The drug is de­signed to ac­ti­vate reg­u­la­to­ry T cells by tar­get­ing IL-2, an ap­proach Lil­ly and Nek­tar be­lieve could put the im­mune sys­tem back on track in fix­ing au­toim­mune dis­eases.

Nek­tar CEO Howard Robin, who is in no way re­luc­tant to talk up the prospects of the drugs the biotech has in the clin­ic, cit­ed this drug for its unique qual­i­ties in the Q1 call back in April. Here’s what he had to say:

Un­like cur­rent im­muno­sup­pres­sant agents, which glob­al­ly weak­en the im­mune sys­tem to on­ly ad­dress dis­ease symp­toms. NK­TR-358 is a first-in-class res­o­lu­tion ther­a­peu­tic de­signed to specif­i­cal­ly cor­rect the un­der­ly­ing pathol­o­gy of au­toim­mune dis­ease. NK­TR-358 is the on­ly med­i­cine of its kind in clin­i­cal tri­als. It has the po­ten­tial to have a pro­found ef­fect on a num­ber of im­mune and in­flam­ma­to­ry dis­or­ders, in­clud­ing lu­pus, IBD, RA, pso­ri­a­sis, MS, Type 1 di­a­betes and even al­ler­gy.

With an as­set that has this much broad po­ten­tial in so many in­di­ca­tions, we be­lieve the right strat­e­gy for NK­TR-358 is to seek a co-de­vel­op­ment and co-pro­mo­tion part­ner­ship with a com­pa­ny that has a strong lead­er­ship po­si­tion in im­munol­o­gy and im­por­tant­ly shares our vi­sion for the broad de­vel­op­ment of NK­TR-358. Our goal is to en­ter in­to part­ner­ship this year.

Nek­tar pre­clin­i­cal R&D chief Jonathan Za­levsky, who’s cred­it­ed as the in­ven­tor, added:

Un­like cur­rent im­muno­sup­pres­sant agents, which glob­al­ly weak­en the im­mune sys­tem to on­ly ad­dress dis­ease symp­toms. NK­TR-358 is a first-in-class res­o­lu­tion ther­a­peu­tic de­signed to specif­i­cal­ly cor­rect the un­der­ly­ing pathol­o­gy of au­toim­mune dis­ease. NK­TR-358 is the on­ly med­i­cine of its kind in clin­i­cal tri­als. It has the po­ten­tial to have a pro­found ef­fect on a num­ber of im­mune and in­flam­ma­to­ry dis­or­ders, in­clud­ing lu­pus, IBD, RA, pso­ri­a­sis, MS, Type 1 di­a­betes and even al­ler­gy.

He went on to say that this is the kind of drug that can be self-ad­min­is­tered.

That’s the kind of pro­file that Lil­ly — a ma­jor play­er in di­a­betes — finds at­trac­tive. It’s al­so the kind of big ear­ly-stage deal that for­mer CEO John Lech­leit­er was large­ly un­will­ing to pur­sue. New CEO Dave Ricks, though, has proven ea­ger to add more drugs to the pipeline af­ter a string of new drug ap­provals capped by a big set­back with the FDA’s re­jec­tion of baric­i­tinib.

Nek­tar’s Robin has been wheel­ing and deal­ing over the last few months. The com­pa­ny’s IL-2 re­search has spawned im­muno-on­col­o­gy pro­grams as well as a Take­da part­ner­ship in March. That fol­lowed a com­bo deal with Bris­tol-My­ers Squibb last fall. And af­ter adding Phase III da­ta on its abuse-re­sis­tant opi­oid NK­TR-181 just days ago, Robin re­vived talk of a Big Phar­ma part­ner­ship there as well. Nek­tar, though, al­so just ran in­to a set­back af­ter Eu­ro­pean ex­perts snubbed its pitch for an ear­ly OK on its can­cer drug Onzeald (NK­TR-102).

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

LAST UPDATED AUGUST 13

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

How much has pre­ci­sion med­i­cine helped? A new NCI study of­fers clues

Does precision medicine work?

The approach, based on finding a drug to target a patient’s specific genes, has undoubtedly saved individual lives, spurring Lazarus-like reversals in health in once-terminally ill patients. But critics have pointed out that its pursuit has meant drug companies spending hundreds of millions of dollars to target mutations that affect narrow slices of the populations, and that many of the gains researchers thought it would bring have eroded as cancers evolve resistance.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Credit: Galaxy Life Sciences

Galaxy Life Sci­ences lands $50 mil­lion deal to build in cen­tral Mass­a­chu­setts bio­man­u­fac­tur­ing park

Webster, MA-based real estate developer Galaxy Life Sciences struck a roughly $50 million deal to build in a biomanufacturing park in Worcester, an up-and-coming biotech hotspot about an hour west of Boston.

Galaxy paid $1.9 million for a 6-acre plot, on which it intends to construct a $50 million building grossing 95,000 to 180,000 square feet. The space will be designed to accommodate research and development, or manufacturing, and could employ 125 to 150 workers, according to the Worcester Telegram & Gazette. Construction is expected to begin this spring and wrap up in about a year.

No­var­tis’ CAR-T part­ner in Chi­na wraps $383M take-pri­vate deal en­gi­neered by CEO

After 13 years on Nasdaq, Cellular Biomedicine Group is returning to private hands.

CEO Tony (Bizuo) Liu is a key advocate of the deal, leading a consortium of mostly Chinese investors including other top company execs, Yunfeng Capital and TF Capital — even as the company is getting more entrenched in the US with its CAR-T and other cell therapy work.

Shareholders are receiving $19.75 per share $CBMG, which translates to a premium of 31.4% over the 30 trading-day average price as of August 11. The stock, though, has dropped significantly since the consortium first put in its proposal in November. Compared to then, the acquisition price marks only a 11.8% increase.