Want to buy a pain ther­a­py? Nek­tar lays out a PhI­II sales pitch

Nek­tar Ther­a­peu­tics has a late-stage pain drug to sell to some­one. And this morn­ing the San Fran­cis­co-based biotech — which has been build­ing a fo­cus on on­col­o­gy — added a Phase III read­out show­ing NK­TR-181’s abil­i­ty to hand­i­ly beat out a place­bo in treat­ing chron­ic pain.

The key at­trac­tion to this drug, though, is Nek­tar’s $NK­TR billing this ther­a­py as the first mu-opi­oid ag­o­nist to lessen the pain with­out trig­ger­ing the eu­pho­ria that launched the opi­oid epi­dem­ic in the US.

First, the da­ta. In the Phase III tri­al, pa­tients suf­fer­ing from low back pain were titrat­ed to up to 400 mg twice dai­ly, with pain scores drop­ping an av­er­age of 63%, then moved in­to a dou­ble-blind phase while in­ves­ti­ga­tors tracked av­er­age week­ly pain scores for 12 weeks. Pain scores in the place­bo arm in­creased on the rat­ing scale by 1.46 com­pared to a low­er 0.92 high­er score for the drug arm. That was sta­tis­ti­cal­ly sig­nif­i­cant, says Nek­tar, though a long way from liv­ing pain free.

And if NK­TR-181 does hit the mar­ket even­tu­al­ly, it won’t be up against a place­bo in the re­al world.

Nek­tar, though, has been en­thu­si­as­ti­cal­ly pump­ing ev­i­dence that the drug doesn’t lead to eu­pho­ria, killing an ef­fect that made opi­oids too pop­u­lar with ad­dicts. Its shares shot up more than 20% this morn­ing.

Nek­tar ex­ecs didn’t hold back on tout­ing the re­sults.

“As a new mol­e­cule, NK­TR-181 has a high­ly dif­fer­en­ti­at­ed pro­file with the po­ten­tial to be one of the most im­por­tant ad­vance­ments in pain med­ica­tion,” not­ed CEO Howard Robin in a state­ment. He went on to say the com­pa­ny is com­mit­ted to bring­ing the drug to pa­tients as quick­ly as pos­si­ble.

Just don’t ex­pect Nek­tar to mar­ket the drug or file for an ap­proval.

A cou­ple of weeks ago the CEO told an­a­lysts:

As­sum­ing pos­i­tive Phase 3 ef­fi­ca­cy re­sults from the cur­rent SUM­MIT-07 tri­al, we plan to out-li­cense NK­TR-181 to a com­pa­ny that has a strong pres­ence and long-term com­mit­ment in the pain mar­ket.

That’s what Nek­tar did with Movan­tik (nalox­e­gol), an opi­oid in­duced con­sti­pa­tion drug which was li­censed to As­traZeneca. Nek­tar in­sists that drug is a block­buster in the mak­ing, though sales have been off to a slow start.

The big fo­cus at Nek­tar now cen­ters on NK­TR-214, a pre­clin­i­cal bi­o­log­ic that the com­pa­ny be­lieves can play a role in im­muno-on­col­o­gy. Last fall Nek­tar pulled the wraps off a 50/50 deal to col­lab­o­rate with Bris­tol-My­ers Squibbs to see how their ex­per­i­men­tal drug match­es up with Op­di­vo, one of the lead­ers in the first wave of check­point in­hi­bi­tion.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Jan van de Winkel, Genmab CEO

Seat­tle Ge­net­ics, Gen­mab turn on TV for a high­light reel in cer­vi­cal can­cer — but a ri­val biotech promis­es a bet­ter show

Seattle Genetics $SGEN and their partners at Genmab $GMAB polished up some positive Phase II numbers for their antibody drug conjugate tisotumab vedotin — you can call it TV — for recurrent cervical cancer. And while they mapped out a shortcut to a potential quick approval, the big challenge for this team is being presented by a rival biotech which muscled its way into the spotlight for the same indication a year ago.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Days af­ter In­ter­cept re­jec­tion, Akero surges on ‘un­prece­dent­ed‘ NASH da­ta

A year and a half after scoring a $70 million Series B and a top Gilead executive as CEO, Akero Therapeutics has announced new data on their NASH drug. And with the field still reeling from a surprise FDA rejection this week, the news was enough to send their stock surging.

Akero had already said in March that its lead drug had beaten placebo in its Phase II trial, reducing liver fat by 14% in the highest dose group compared to 0.3% in placebo, according to MRI scans. But although NASH is an obesity-related condition and results from fatty buildup in the liver, the real immediate question for any therapy is whether it can resolve the fibrosis and inflammation that results from that buildup. Those data require biopsying the patients, a longer and more invasive process that was further complicated by a pandemic.