Ex­or­cis­ing Mar­tin Shkre­li’s ghost, Kalo­Bios steps out of Ch. 11 and back in­to the biotech busi­ness

Six months af­ter Mar­tin Shkre­li’s brief, tur­bu­lent role as the con­tro­ver­sial sav­ior of the trou­bled Kalo­Bios end­ed in Chap­ter 11 and near ex­tinc­tion, new CEO Cameron Dur­rant is turn­ing the last page on that chap­ter of pulp fic­tion dra­ma.

This morn­ing Kalo­Bios says it has emerged from bank­rupt­cy with $14 mil­lion in fi­nanc­ing, a new­ly re­or­ga­nized board and a com­plet­ed deal with Sa­vant Ne­glect­ed Dis­eases to de­vel­op ben­znida­zole for the treat­ment of rare cas­es of Cha­gas dis­ease.

Cameron Dur­rant, Kalo­Bios CEO

“We re­al­ly see this as a clean slate,” Dur­rant tells me. “And it was pret­ty much dead twice over.”

The first near death ex­pe­ri­ence came af­ter a se­ries of big clin­i­cal set­backs in the com­pa­ny left in­vestors won­der­ing what man­age­ment was think­ing. Backed in­to a cor­ner, ex­ecs threat­ened to file for bank­rupt­cy un­less they could work out a deal.

And then Shkre­li ar­rived on the scene, bring­ing a horde of jour­nal­ists in his wake.

The biotech CEO had been boot­ed out of Retrophin and start­ed Tur­ing, grab­bing an old drug called Dara­prim and jack­ing up the price more than 5000%. But rather than duck­ing out a back door in the face of an on­line lynch mob, a de­fi­ant Shkre­li fa­mous­ly of­fered a one-fin­ger salute to all of his crit­ics, in­clud­ing me and every oth­er jour­nal­ist who ques­tioned his ac­tions. In short or­der he en­gi­neered a takeover of Kalo­Bios and ev­i­dent­ly was look­ing to re­peat his price goug­ing with ben­znida­zole.

Mar­tin Shkre­li at the De­vel­op­ments in the Pre­scrip­tion Drug Mar­ket: Over­sight hear­ing, 2016

In­stead, he was ar­rest­ed, perp walked and charged with bla­tant fi­nan­cial fraud, which he has de­nied. Kalo­Bios was kicked off Nas­daq and left in a sham­bles. Now Dur­rant wants to make it clear that Shkre­li has no role left at the com­pa­ny—and hasn’t since the blow up last De­cem­ber—had his eq­ui­ty stake in the biotech cut to 14% and that the com­pa­ny is work­ing on get­ting that back as well.

While Shkre­li may be long gone, some of the ba­sic build­ing blocks he had been as­sem­bling will be key to the biotech’s re­cov­ery. Dur­rant is work­ing with the FDA on es­tab­lish­ing a de­vel­op­ment plan for ben­znida­zole, look­ing to win a po­ten­tial pri­or­i­ty re­view vouch­er from the FDA that by it­self could be worth a for­tune on the bio­phar­ma mar­ket.

“We’re hop­ing for a 505(b)(2) ap­proach,” says Dur­rant, re­fer­ring to an ab­bre­vi­at­ed clin­i­cal de­vel­op­ment plan that can use da­ta from oth­er stud­ies the com­pa­ny didn’t con­duct it­self. But they need to spend some time work­ing that out with the FDA.

Dur­rant al­so wants to get its an­ti­body KB003, a GM-CSF an­tag­o­nist, in the clin­ic for chron­ic myelomono­cyt­ic leukemia. And he’ll look for part­ners to take over 004 and 002.

The new CEO is work­ing on ar­rang­ing some fresh fi­nanc­ing and has lots on his plate. But Dur­rant al­so wants to ex­or­cise the ghost of Mar­tin Shkre­li once and for all, vow­ing a new ap­proach on drug pric­ing that is the po­lar op­po­site to the pro­tag­o­nist’s role Shkre­li played.

As for Shkre­li, he’s as un­re­pen­tant as ever. Just yes­ter­day, he had this to of­fer me.

https://twit­ter.com/Mar­tin­Shkre­li/sta­tus/748476570789109760

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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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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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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George Yancopoulos (Regeneron)

UP­DAT­ED: 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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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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Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.