Patrick Soon-Shiong, AP

Patrick Soon-Sh­iong merges trou­bled 'moon shot' Nan­tK­west and cell ther­a­py play Im­mu­ni­ty­Bio in late-stage ex­pan­sion

Once one of the hottest brands in biotech, Patrick Soon-Sh­iong’s next-gen can­cer brain­child Nan­tK­west has tak­en its lumps in re­cent years with lit­tle to show from its nat­ur­al killer cell plat­form. Now, with his cell ther­a­py play Im­mu­ni­ty­Bio mov­ing much faster in the clin­ic, Soon-Sh­iong will merge the two com­pa­nies to­geth­er to stream­line their mar­ket as­pi­ra­tions.

Nan­tK­west will re­verse merge with Soon-Sh­iong’s Im­mu­ni­ty­Bio in a stock-for-stock trans­ac­tion to bring 11 late-stage nat­ur­al killer and cell ther­a­py can­di­dates for on­col­o­gy and in­fec­tious dis­eases un­der a sin­gle roof, the com­pa­nies said Mon­day.

Rich Ad­cock

Soon-Sh­iong, a bil­lion­aire sur­geon and a big-tick­et name in bio­phar­ma, will stay on as ex­ec­u­tive chair­man while Rich Ad­cock, Nan­tK­west’s reign­ing CEO, will side­step in­to the same role at the new firm. The merg­er is set to close in the first half of 2021 with Im­mu­ni­ty­Bio in­vestors tak­ing the li­on’s share of the new com­pa­ny at a ful­ly di­lut­ed 78%.

Soon-Sh­iong stepped down from the CEO role in Oc­to­ber in fa­vor of Ad­cock five years in­to Nan­tK­west’s whirl­wind pub­lic of­fer­ing. The off-the-shelf nat­ur­al killer play, which Soon-Sh­iong de­scribed as his “can­cer moon shot,” was once the most valu­able IPO in biotech be­fore see­ing its share prices plum­met with lit­tle clin­i­cal da­ta to hold up and a very pub­lic re­con­sid­er­a­tion of the com­pa­ny’s hype.

For­tunes changed in ear­ly 2020 af­ter Soon-Sh­iong tout­ed ear­ly re­sults show­ing one pan­cre­at­ic can­cer pa­tient with a com­plete re­sponse, putting wind in the flag­ging com­pa­ny’s sales. On Fri­day, Nan­tK­west $NK shares closed trad­ing at $10.26.

So with lit­tle still to show for his ef­forts, Soon-Sh­iong will guide a new firm with a more di­ver­si­fied pipeline and a lit­tle bit more to show on the clin­i­cal side. Im­me­di­ate­ly fol­low­ing news of the merg­er Mon­day, Im­mu­ni­ty­Bio, a biotech tar­get­ing the in­nate and adap­tive im­mune sys­tem, trum­pet­ed re­sults from a Phase II/III tri­al show­ing its IL-15″su­per­ag­o­nist” Ank­ti­va (N-803) post­ed a 72% com­plete re­sponse rate in BCG un­re­spon­sive non-mus­cle in­va­sive blad­der can­cer af­ter 12 months of treat­ment.

That can­di­date comes from Im­mu­ni­ty­Bio’s im­munother­a­py fu­sion pro­tein, im­munomod­u­la­tor, and ade­n­ovirus plat­forms, which the biotech is al­so uti­liz­ing to chase a Covid-19 vac­cine. That can­di­date is an­gling for a Phase I hu­man study af­ter com­plete­ly clear­ing tri­al pri­mates’ air­ways in a U.S. gov­ern­ment-spon­sored tri­al, the com­pa­ny re­cent­ly said.

“What dis­tin­guish­es the merged en­ti­ty is the late stage im­munother­a­py prod­uct pipeline that is de­signed to elim­i­nate the need for high-dose chemother­a­py, im­prove the out­comes of cur­rent CAR T cell ther­a­pies, and ex­tend be­yond check­point in­hibitors,” Soon-Sh­iong said in a re­lease. “With 13 clin­i­cal tri­als across mul­ti­ple tu­mor types at Phase I to III and with the com­bined tal­ent in re­search, clin­i­cal de­vel­op­ment and man­u­fac­tur­ing, the merged en­ti­ty is poised to be a leader in the im­munother­a­py space.”

In all, the new­co will have 13 as­sets in clin­i­cal tri­als, ac­cord­ing to a re­lease, with IP run­ning out to 2035. The com­pa­ny will go on­line with a com­bined 200,000 square feet of man­u­fac­tur­ing and clin­i­cal space as it takes mul­ti­ple runs at the mar­ket.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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