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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

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Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.