Brian Kotzin, Nektar

Af­ter an up-and-down year, Nek­tar watch­es de­vel­op­ment head Wei Lin walk away as it pur­sues pipeline re­bound

More than any oth­er year in re­cent mem­o­ry, 2020 was a roller­coast­er of highs and lows —most­ly lows. Just ask San Fran­cis­co’s Nek­tar: De­spite ditch­ing its opi­oid pro­gram in Jan­u­ary and of­fload­ing roy­al­ties to its two US-mar­ket­ed meds, the biotech still has hopes for its pipeline to hit a re­bound this year.

But that re­bound won’t hap­pen un­der the watch of se­nior VP and head of de­vel­op­ment Wei Lin, who is step­ping down and leav­ing im­munol­o­gy head Bri­an Kotzin to step in.

Lin is “leav­ing the com­pa­ny to pur­sue an­oth­er op­por­tu­ni­ty,” Nek­tar an­nounced on Wednes­day. It’s un­clear where the Genen­tech vet is head­ed next.

Nek­tar poached Lin from Genen­tech in 2018, where he held roles such as glob­al de­vel­op­ment leader for can­cer im­munother­a­py and se­nior med­ical di­rec­tor over a sev­en-year stint. The Har­vard Med­ical School grad joined Nek­tar as se­nior VP and head of on­col­o­gy be­fore get­ting pro­mot­ed to head of de­vel­op­ment.

“Over the past two years, Wei has played a lead­er­ship role in re­cruit­ing an ex­pe­ri­enced clin­i­cal de­vel­op­ment or­ga­ni­za­tion and ex­e­cut­ing a late-stage clin­i­cal de­vel­op­ment strat­e­gy for BE­M­PEG, po­si­tion­ing it for fu­ture suc­cess,” chief R&D of­fi­cer Jonathan Za­levsky said in a state­ment. “I would like to thank him for his con­tri­bu­tions to Nek­tar, and wish him the best in his next op­por­tu­ni­ty.”

With big shoes to fill, Kotzin is step­ping up as in­ter­im CMO and head of de­vel­op­ment.  The Am­gen vet joined Nek­tar in 2017 and helped lead ear­ly de­vel­op­ment of NK­TR-255, the com­pa­ny’s IL-15 re­cep­tor ag­o­nist cur­rent­ly in two Phase II stud­ies: one for non-Hodgkin’s lym­phoma and mul­ti­ple myelo­ma in com­bo with Rit­ux­an or Darza­lex, and an­oth­er in head, neck and col­orec­tal can­cer paired with Er­bitux. He al­so spear­head­ed the Eli Lil­ly-part­nered NK­TR-358 pro­gram, which is in Phase II for sys­temic lu­pus ery­the­mato­sus and Phase Ib stud­ies for pso­ri­a­sis and atopic der­mati­tis.

At Am­gen, Kotzin served as VP of glob­al clin­i­cal de­vel­op­ment and head of in­flam­ma­tion ther­a­peu­tics, as well as VP of trans­la­tion­al sci­ences and head of med­ical sci­ences/ear­ly de­vel­op­ment.

“This is an ex­cit­ing time for the com­pa­ny with mul­ti­ple reg­is­tra­tional stud­ies un­der­way in a range of tu­mor types for BE­M­PEG, a broad­en­ing clin­i­cal pro­gram for NK­TR-358 in a num­ber of au­to-im­mune dis­or­ders, and an emerg­ing op­por­tu­ni­ty for NK­TR-255 in both hema­to­log­i­cal ma­lig­nan­cies and sol­id tu­mors,” Kotzin said.

Last month, Nek­tar sold the roy­al­ties to Adyno­vate and Movan­tik off to Health­care Roy­al­ty Man­age­ment for $150 mil­lion in cash. The biotech said it would fun­nel most of the mon­ey in­to two pro­grams: be­m­pe­galdesleukin (or NK­TR-214) and NK­TR-255. Be­m­pe­galdesleukin, Nek­tar’s lead pro­gram, is be­ing stud­ied in sev­er­al Phase III tri­als in com­bi­na­tion with Bris­tol My­ers Squibb’s Op­di­vo. The CD122-pref­er­en­tial IL-2 ag­o­nist is be­ing eval­u­at­ed in sev­er­al in­di­ca­tions, in­clud­ing metasta­t­ic melanoma, re­nal cell car­ci­no­ma and mus­cle-in­va­sive blad­der can­cer.

That news came just less than a year af­ter Nek­tar dropped its opi­oid pro­gram, NK­TR-181, which was re­buffed by an FDA ad­comm last Jan­u­ary. The pan­el vot­ed 27-0 against ap­prov­ing the drug, cit­ing con­cerns that pa­tients could abuse it and caus­ing their stock $NK­TR to fall 15%. On Wednes­day morn­ing, the com­pa­ny’s stock was down 0.61%, at $17.97 a share.

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.

Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

Friends and colleagues,

I am writing to provide our annual update on Roivant. These updates are usually restricted to our shareholders, but we are sharing this year’s letter more broadly to announce an upcoming change in my role from CEO to Executive Chairman and the promotion of Matt Gline to Chief Executive Officer.

Reflections on 2020

Much has transpired in the world and at our company since my last annual update in January 2020. One year ago we had just completed our $3 billion transaction with Sumitomo Dainippon Pharma (DSP), and we were evaluating how to reinvest in our business. At the same time, SARS-CoV-2 was still a distant virus barely on our minds. Today it has afflicted the entire world sparing literally no one from its effects.

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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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Bahija Jallal, Immunocore

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.