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.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Opin­ion: US and EU re­views of blood clots and J&J’s Covid vac­cine show why a trans­par­ent process mat­ters

When the CDC’s top advisory committee met last week to review whether a handful of very rare but potentially fatal blood clots with low platelets might be linked to J&J’s Covid-19 vaccine, the assumption was that the committee would, at the very least, follow its own agenda and vote on whether to wait for more data, or make interim age- or risk-based recommendations for the vaccine.

Instead, the committee did neither, punting its vote until this Friday when it can hold a longer discussion with the latest data. None of the ACIP members raised major concerns with the decision, or lack thereof, despite some calls to not pause the vaccine indefinitely.

Nick Leschly, bluebird bio CEO (Jeff Rumans)

Blue­bird says it has more good news for its gene ther­a­py safe­ty, but a pric­ing dis­agree­ment in Ger­many will spur lay­offs

Following two safety scares back in February regarding its sickle-cell program, bluebird bio’s gene therapy appears to be in the clear.

Execs from the Cambridge, MA-based biotech provided another update on LentiGlobin safety concerns Tuesday morning, this time regarding a patient who was thought to have developed a case of myelodysplastic syndrome. After further analyses and testing, investigators have revised the diagnosis to transfusion-dependent anemia and ruled that it is not an incident of the blood cancer.

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UP­DAT­ED: J&J to restart Covid vac­cine ship­ments to Eu­rope as EMA adds safe­ty warn­ing over rare blood clots

The European Medicines Agency’s safety committee on Tuesday recommended adding a warning to the J&J Covid-19 vaccine regarding the rare but sometimes fatal blood clots with low blood platelets. Shortly thereafter, J&J said it would resume shipments of the vaccine to the EU, Norway and Iceland, and update its vaccine’s Summary of Product Characteristics and Package Leaflet to include information on the diagnosis and management of these very rare adverse events.

Jeff Leiden (L) and Samarth Kulkarni

UP­DAT­ED: Ver­tex pays CRISPR $900M to take con­trol of sick­le cell part­ner­ship, bet­ting they can beat blue­bird -- and re­new­ing an­a­lyst­s' skep­ti­cism

When Vertex chairman Jeffrey Leiden and CRISPR Therapeutics CEO Samarth Kulkarni got on the call for the first meeting of the year, the tenor was different than in the dozens of conversations the two had had since they first teamed back in 2015.

Vertex and CRISPR had just shown curative results in ten patients for their gene therapy for sickle cell disease and beta thalassemia. Meanwhile, their main rival in the field, bluebird bio, had suffered the latest in a string of manufacturing setbacks, pushing back their timeline by a year.

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Chen Yu

Chen Yu jumps ship from Vi­vo Cap­i­tal and goes large, al­ly­ing with The Col­umn Group on an in­au­gur­al $824M biotech crossover fund

Over the past 15 years, the crew at The Column Group have gathered more than $2 billion together to pursue their game plan of fostering biotech startups. And it’s been effective. Their portfolio plays have provided a target-rich environment for big players like Roche and J&J and Vertex to come stalking acquisitions.

Recently, though, one of the managing partners at Vivo Capital jumped ship after a very long tenure — 17 years — and went on to quickly create a brand new biotech fund they’re partnered with the VC on called TCG Crossover; TCG X in abbreviated fashion. His name is Chen Yu, and in the midst of the busiest crossover season in the industry’s history, he’s jumping in to the game with an $824 million stake that will be put into play at the junction intersecting biotechs with public markets — with a special side focus on the booming China market, where he’s been a player for years.

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RA Cap­i­tal leads $125M for Janux in VC's lat­est crossover bid

Four months ago, only a short list of people had ever heard of Janux Therapeutics. Today, they have a partnership with Merck, $212 million in VC capital and, it seems, plans for an IPO.

Janux announced Tuesday a $125 million crossover round led by RA Capital, the Boston VC behind a spate of recent pre-IPO financings. Janux declined an interview request, a common move for biotechs preparing to go public in the near future.

Eli Lil­ly plots NDA as sec­ond JAK study backs baric­i­tinib for alope­cia area­ta; Al­ny­lam heads to FDA af­ter full vutrisir­an da­ta pan out

Eli Lilly has posted positive data from its second Phase III study testing its JAK inhibitor baricitinib in spurring hair regrowth among patients suffering from severe alopecia areata.

Investigators reported a dose-dependent response to the drug, with 35% of the subjects in the 4 mg arm achieving 80% or more scalp hair coverage against 22% in the 2 mg arm. That’s in line with the first Phase III readout.

Jami Rubin (EQRx)

Ja­mi Ru­bin, once fa­bled for grilling bio­phar­ma ex­ecs, de­camps to head fi­nance at drug pric­ing dis­rupter

As Goldman Sachs’ top pharmaceutical analyst, Jami Rubin was known for asking the tough questions. Now, as she takes the lead on EQRx’s mission to rewrite the rules of drug pricing, we’ll see how good her answers are.

Rubin made the jump to biotech on April 5, becoming EQRx’s new CFO, the company said Monday. She’s coming from PJT Partners, where she’s been a partner providing strategic guidance for biotech and pharmaceutical companies for the last couple years. With EQRx’s recent $500 million Series B round in the books, it wouldn’t be a surprise if she was already lining up a public debut.

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