Af­ter ax­ing a top drug, Mil­len­do bags a PhII re­place­ment with biotech buy­out

Mil­len­do Ther­a­peu­tics has ac­quired a small French biotech named Al­izé Phar­ma SAS  ̶  and its Phase II obe­si­ty-re­lat­ed drug  ̶  in a deal that helps fill out Mil­len­do’s pre­vi­ous­ly thin­ning pipeline in or­phan en­docrine dis­eases.

Mil­len­do wouldn’t dis­close the pric­etag, but said the ac­qui­si­tion was an all-stock trans­ac­tion. The deal gets Mil­len­do a Phase II as­set called liv­o­le­tide, a drug meant to treat a rare ge­net­ic dis­ease called Prad­er-Willi Syn­drome (the most com­mon form of ge­net­ic obe­si­ty). A big con­cern for these pa­tients is the ex­ces­sive hunger, or hy­per­pha­gia, that re­sults in over-eat­ing. Pre­clin­i­cal and clin­i­cal da­ta on liv­o­le­tide have in­di­cat­ed that the drug de­creas­es hy­per­pha­gia and neg­a­tive food-re­lat­ed be­hav­iors, Mil­len­do says.

Ju­lia Owens

This new as­set helps fill a gap in Mil­len­do’s pipeline left by the ex­it of MLE4901, a re­cent­ly-axed pro­gram the Ann Ar­bor com­pa­ny li­censed from As­traZeneca last year. The drug was meant to treat poly­cys­tic ovary syn­drome, but flopped its Phase IIb study. In­ter­est­ing­ly, the li­cense for the now-de­funct MLE4901 came in con­junc­tion with a $62 mil­lion Se­ries B back­ing led by New En­ter­prise As­so­ci­ates. Ac­cord­ing to Xcon­o­my, in­vestors were hes­i­tant to close the deal un­til Mil­len­do got MLE4901 in its pipeline. But that pro­gram was some­what short lived.

In a press re­lease last month an­nounc­ing pos­i­tive news for a sep­a­rate com­pound, Mil­len­do slipped in a one-lin­er at the end: “Sep­a­rate­ly, Mil­len­do has de­cid­ed to dis­con­tin­ue de­vel­op­ment of MLE4901 af­ter as­sess­ment of the clin­i­cal risks and ben­e­fits of the pro­gram.”

Mil­len­do’s pres­i­dent and CEO Ju­lia Owens tells me it was safe­ty con­cerns that forced the com­pa­ny to shut the pro­gram down.

“Some things work and some things don’t. That’s why our Se­ries B in­vestors want­ed to bet on two com­pounds,” Owens said.

Thier­ry Abri­b­at

Mil­len­do’s lead com­pound ATR-101 just got the OK to ad­vance in­to Phase IIb tri­als af­ter pos­i­tive re­sults led to an ear­ly halt of a Phase II tri­al in con­gen­i­tal adren­al hy­per­pla­sia, a rare en­docrine dis­ease.

Now, Mil­len­do is charg­ing ahead with ATR-101 and its new­ly-ac­quired liv­o­le­tide. Owens said ATR-101 will en­ter Phase IIb tri­als in 2018, and plans for liv­o­le­tide are still in the works.

Post ac­qui­si­tion, Mil­len­do will con­tin­ue to op­er­ate the for­mer Al­izé Phar­ma SAS fa­cil­i­ties (and keep its ex­ist­ing team) to serve as Mil­len­do’s Eu­ro­pean R&D base. Thier­ry Abri­b­at, the founder and pres­i­dent of Al­izé, will join Mil­len­do’s board.

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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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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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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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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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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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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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.