Backed by neu­ro en­thu­si­ast Arch, up­start Black­Thorn tack­les some tough tar­gets with $40M round

Mark Cor­ri­g­an

Arch Ven­ture Part­ners has fos­tered a new neu­ro­sciences biotech com­pa­ny that will now fol­low a sim­i­lar trail to the one be­ing blazed by the high-pro­file start­up De­nali. Work­ing with John­son & John­son In­no­va­tion, Al­ti­tude Life Sci­ence Ven­tures, Mer­cury Fund, Alexan­dria Re­al Es­tate Eq­ui­ties as well as an “undis­closed crossover fund,” the VC is un­veil­ing Black­Thorn Ther­a­peu­tics to­day, which will now have a $40 mil­lion Se­ries A to play with as it looks to help re­vive a com­plex and chal­leng­ing field.

Black­Thorn in­tends to tar­get neu­robe­hav­ioral dis­or­ders such as autism spec­trum dis­or­der, ob­ses­sive com­pul­sive dis­or­der, de­pres­sion and schiz­o­phre­nia, fields that de­fied a gen­er­a­tion of Big Phar­ma clin­i­cal ef­forts and saw many of the biggest play­ers like As­traZeneca or Glax­o­SmithK­line ei­ther drop out or scale far back.

Big Phar­ma’s re­treat, though, was fol­lowed by rapid progress in ge­nomics. And Black­Thorn, de­scribed by Ex­ec­u­tive Chair­man Mark Cor­ri­g­an as a “broth­er com­pa­ny to De­nali,” plans to fol­low up on that progress by ad­vanc­ing new tech­nolo­gies that can help iden­ti­fy spe­cif­ic pa­tient pop­u­la­tions that can be helped by spe­cif­ic ther­a­pies. And it’s start­ing out with a well ad­vanced pro­gram, pick­ing up a failed drug from Eli Lil­ly with plans to launch Phase II study.

The treat­ment – a no­ci­ceptin re­cep­tor an­tag­o­nist – is now dubbed BTRX- 246040.

Lil­ly “had put it in a cou­ple of ear­ly Phase II pro­grams,” says Cor­ri­g­an. “It failed in ma­jor de­pres­sive dis­or­ders,” but there were al­so in­trigu­ing re­sults to fol­low up on.

Cor­ri­g­an is care­ful to note, though, that this is just the be­gin­ning of build­ing a se­ri­ous pipeline of new drugs for neu­robe­hav­ioral con­di­tions. The big idea at the com­pa­ny is that they can ad­vance new tools for imag­ing and as­sess­ment that will al­low the biotech to do a much bet­ter job at track­ing the im­pact of a new drug on pa­tients. Done the right way, Black­Thorn ex­pects it can skirt the pit­falls that claimed so many projects be­fore.

At the same time, Cor­ri­g­an says that reg­u­la­tors will be asked to look at these dis­eases and the ways they can be treat­ed dif­fer­ent­ly, adapt­ing to the progress in or­der to avoid see­ing a re­peat of the same mis­takes. But at this stage, he adds, “I think the FDA is open to some of these dis­cus­sions.”

The biotech has a cast of sci­en­tif­ic ad­vis­ers in its cor­ner with an im­pres­sive set of re­sumes. The Scripps team of Ed­ward Roberts, PhD, and Hugh Rosen, MD, PhD, who co-found­ed Re­cep­tos, are on board. And the ad­vi­so­ry group in­cludes Steven Hy­man, MD, di­rec­tor of the Stan­ley Cen­ter for Psy­chi­atric Re­search and core mem­ber at the Broad In­sti­tute of MIT and Har­vard Uni­ver­si­ty, and Matt State, MD, PhD, chair of the UCSF De­part­ment of Psy­chi­a­try and di­rec­tor of the Lan­g­ley Porter Psy­chi­atric In­sti­tute.

For­mer Cel­gene re­search ex­ec Tom Daniel is ad­vis­ing the com­pa­ny.

Cor­ri­g­an says you can ex­pect to see Black­Thorn start adding staffers to the 13-mem­ber team which has al­ready signed on. And there are plans afoot to link up with tech part­ners, much like De­nali has done, as it builds its plat­form. That’s some­thing that Daniel al­so knows some­thing about.

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.