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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

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Someit Sidhu, JATT

An­oth­er life sci­ences SPAC has popped up from a small biotech CEO with the help of Take­da, No­var­tis vet­er­ans

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The SPAC train has slowed down since the extraordinarily high levels from late 2020 into early this year, but Tuesday saw the filing of a new blank-check company targeting the life sciences industry.

Jatt Acquisition submitted its SEC paperwork Tuesday, penciling in an estimated raise of $120 million as it sets its sights on a reverse merger partner. The SPAC is run by Someit Sidhu, a co-founder of Pathios Therapeutics, as well as CEO of Akaza Bioscience and Izana Bioscience. Sidhu will control about 97% of the blank-check company’s shares, per the S-1.

In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Scientists have come up with the first evidence that Regeneron’s antibody cocktail, which has so far only been authorized for the outpatient setting, may reduce deaths of hospitalized Covid-19 patients — albeit only a subset.

The combination of casirivimab and imdevimab is the subject of the latest data cut from RECOVERY, the large-scale UK-based trial testing a variety of potential treatments. In total, 9,785 patients hospitalized with Covid-19 were enrolled in this arm of the study and were randomly assigned to receive either usual care plus the intravenous combo or usual care alone.

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Stephen Hahn (AP Images)

UP­DAT­ED: Ex-FDA com­mish Stephen Hahn joins Flag­ship, a ven­ture group that spawned Covid-19 vac­cine mak­er Mod­er­na

That revolving door between the FDA and industry is spinning even faster than usual.

Former FDA commissioner Stephen Hahn is joining Flagship Pioneering, the venture outfit that founded Moderna — which raced its way to an FDA EUA for a Covid-19 vaccine that is making billions of dollars– as the new CMO of its Preemptive Medicine and Health Security initiative.

Flagship confirmed the hire — first reported in The Washington Post — in a statement out late Monday.

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