Nek­tar, stung by new in­vestor law­suit over IL-2 drug, se­cures $150M for Keytru­da com­bo piv­otal tri­al

Nek­tar Ther­a­peu­tics’ IL-2 drug hasn’t al­ways lived up to ex­pec­ta­tions in the four and a half years since it scored a promi­nent al­ly in Bris­tol My­ers Squibb — a pact that even­tu­al­ly bal­looned to $3.6 bil­lion.

The ear­ly da­ta snap­shots for a com­bo of be­m­pe­galdesleukin, or NK­TR-214, with Op­di­vo, in par­tic­u­lar, rat­tled in­vestors, and the biotech’s ex­pla­na­tion, pin­ning the blame on man­u­fac­tur­ing, did lit­tle to sal­vage their stock price. In fact, just yes­ter­day, two share­hold­ers sued the board of di­rec­tors for hyp­ing tri­al re­sults and then sell­ing $171 mil­lion worth of stock at an in­flat­ed price.

But it hasn’t stopped new part­ners from see­ing the po­ten­tial in this par­tic­u­lar I/O add-on to the main­stay check­point in­hibitors.

Mer­ck has jumped in for an ex­pand­ed col­lab­o­ra­tion to test Keytru­da with be­m­peg in a reg­is­tra­tional tri­al for squa­mous cell car­ci­no­ma of the head and neck, adding to a slate of on­go­ing Phase III pro­grams Nek­tar has with Bris­tol My­ers. And they won’t be run­ning the tri­al on their own dime; Abing­worth and Black­stone have promised, through their SFJ Phar­ma­ceu­ti­cals sub­sidiary, to bankroll the study with a com­mit­ment of up to $150 mil­lion.

In re­turn, Nek­tar would pay suc­cess-based an­nu­al mile­stone pay­ments over sev­en to eight years — but on­ly if be­m­peg is ap­proved for the spec­i­fied in­di­ca­tions.

The head and neck can­cer study — which fol­lows a dose op­ti­miza­tion study ex­plor­ing Keytru­da plus be­m­peg across a suite of can­cers in­clud­ing melanoma, non-small cell lung can­cer and urothe­lial car­ci­no­ma — is ex­pect­ed to wrap up in 2024.

Jonathan Za­levsky

“Ear­li­er stud­ies of BE­M­PEG in com­bi­na­tion with im­mune check­point in­hibitors, al­so known as ICIs, eval­u­at­ed in pa­tients with im­mune-sen­si­tive can­cers have shown the po­ten­tial to in­crease and deep­en treat­ment re­spons­es as com­pared to his­tor­i­cal rates for ICIs alone,” Jonathan Za­levsky, chief R&D of­fi­cer at Nek­tar, said in a state­ment.

Mer­ck’s PD-1, he added, is the lead­ing check­point in­hibitor in the set­ting of ad­vanced head and neck can­cer.

Bri­an Kotzin

The Nek­tar team led by Za­levsky and Bri­an Kotzin, who re­cent­ly re­placed Wei Lin as head of de­vel­op­ment, is tasked with plan­ning and car­ry­ing out the tri­al start­ing lat­er this year, which will tar­get 500 pa­tients with metasta­t­ic or un­re­sectable re­cur­rent SC­CHN whose tu­mors ex­press PD-L1.

With piv­otal Op­di­vo/be­m­peg da­ta loom­ing for can­cers of the skin, kid­ney and blad­der, they are bank­ing on a pipeline re­bound af­ter Nek­tar chopped an opi­oid pro­gram and sold off roy­al­ties to their two mar­ket­ed drugs to fo­cus on the I/O branch.

Back in 2019 CEO Howard Robin as­sured in­vestors that the “soft­en­ing up” of re­spons­es ob­served in the ear­ly tri­als had to do with a sub­op­ti­mal batch of drug ma­te­r­i­al. And he promised it won’t hap­pen again.

An­a­lysts aren’t ready to buy in just yet, es­pe­cial­ly giv­en the fierce com­pe­ti­tion from all the new play­ers that have shown up on the IL-2 scene.

As SVB Leerink an­a­lyst Daina Gray­bosch wrote in a re­cent note:

Pre­sen­ta­tions at re­cent sci­en­tif­ic con­fer­ences high­light the promise of Nek­tar’s ear­ly pipeline, but in­vestors have made up their mind on the promise of be­m­pe­galdesleukin and we ex­pect the stock to re­main stub­born­ly flat un­til ran­dom­ized da­ta — slip­ping an­oth­er quar­ter to 2022.

Billed as a CD122-pref­er­en­tial IL-2 path­way ag­o­nist, be­m­peg is de­signed to un­leash the can­cer-killing sig­nal while keep­ing tox­i­c­i­ty low enough for out­pa­tient ad­min­is­tra­tion.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

UP­DAT­ED: J&J paus­es vac­cine roll­out as feds probe rare cas­es of blood clots

The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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Patrizia Cavazzoni, new CDER director

Pa­trizia Cavaz­zoni named per­ma­nent di­rec­tor of CDER, adding to ques­tions around where Wood­cock will end up

Patrizia Cavazzoni on Monday became the permanent director of the FDA’s Center for Drug Evaluation and Research, which puts to rest the idea that Janet Woodcock, Cavazzoni’s predecessor, might return to lead CDER if she isn’t made permanent commissioner.

Woodcock, who’s currently serving as acting commissioner and principal medical advisor to the commissioner, a position she was detailed to last year, may not make the move to permanent commissioner because of lingering questions from Senate Democrats. She previously served as director of CDER since 1994. Cavazzoni took over as acting director of CDER when Woodcock moved over to Operation Warp Speed to run the therapeutics side of the Trump-era program.

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Tim Lu, Senti Bio CEO (MIT)

Tim Lu’s gene-cir­cuit star Sen­ti signs up for a $645M dis­cov­ery al­liance with Roche sub Spark

Three months after bringing in Bayer and a group of new investors in his first mega-round, Senti Bio chief Tim Lu now has the first high-profile Big Pharma alliance to help burnish his prospects for a cutting-edge breakthrough in gene therapies.

Spark Therapeutics — which Roche acquired as its base camp in gene therapy development — has turned to Senti in a collaboration aimed at using its synthetic gene circuit tech in new programs aimed at the CNS, eye and liver.

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Pankaj Bhargava, MPM executive partner

Pankaj Bhar­ga­va was a cen­tral fig­ure in the group fash­ion­ing Gilead’s on­col­o­gy strat­e­gy. Now he’s jumped to the VC side and the next-gen game at Dana-Far­ber

Over the past 3 years, Pankaj Bhargava played a key role at Gilead as therapeutics area head of oncology, which put him in the dead center of one of the busiest pipeline makeovers in the industry.

“When I joined (the big biotech), there was a clear realization that Gilead had missed the first boat with immuno-oncology,” he tells me. “We hadn’t gone into the PD-1s, the checkpoints, etc. They had just bought Kite and the question was how do we get into oncology.”

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Fifth Cir­cuit sides with FTC in ma­jor pay-for-de­lay set­tle­ment case

The US Court of Appeals for the Fifth Circuit on Tuesday upheld the Federal Trade Commission’s ruling that generic drugmaker Impax Laboratories should be charged with antitrust violations for accepting payments worth about $100 million to delay the entry of a generic opioid for more than two years.

The court’s opinion upheld the FTC’s anticompetitive findings on the deal between Impax (now owned by Amneal Pharmaceuticals) and Endo Pharmaceuticals, under which Endo committed to not market an authorized generic, which increased Impax’s projected profits by $24.5 million. Endo agreed to pay Impax credits for the shrunken market that Impax would inherit if, as expected, Endo made a successful hop to a reformulated Opana ER.

Opin­ion: Biden needs to step up and nom­i­nate an FDA com­mis­sion­er

Enough with the waiting. President Joe Biden needs to embrace the FDA during this pandemic and kickstart the Senate confirmation process for the next permanent commissioner.

And this needs to happen quickly. There are plenty of qualified candidates for the role outside of acting commissioner Janet Woodcock and Josh Sharfstein. Biden needs to move fast not because the biopharma world struggles with even the perception of FDA uncertainty (it does), but because thousands of FDA employees have been dealing with four years of political smears while putting in overtime to review thousands of Covid-19 drug and vaccine trials, and to authorize three safe vaccines in record time.

Bob Nelsen (Michael Kovac/Getty Images)

End­points ex­clu­sive: Bob Nelsen's Re­silience snags Flori­da CD­MO work­ing with the De­fense De­part­ment on Covid-19 an­ti­body

Resilience has only been in existence for less than six months, but Bob Nelsen’s next-gen manufacturing play has made plenty of moves shortly after debuting with an $800 million launch round. Now, the biotech looking to change drug manufacturing is picking up a Florida CDMO partnered with the Department of Defense on a Covid-19 antibody.

Resilience is acquiring CDMO Ology Bioservices in a deal that will add two manufacturing sites to the bicoastal biotech’s footprint as well as a government-backed monoclonal antibody, a source close to the matter said Monday. Financial terms of the deal were not available.

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