Take­da joins mi­cro­bio­me-fo­cused biotech part­ner's $52.6M raise as it pur­sues more in-house can­cer work

A high-pro­file col­lab­o­ra­tion with Take­da back in late 2018 be­stowed up­on En­terome some phar­ma val­i­da­tion and sig­nif­i­cant cash — $50 mil­lion up­front and an­oth­er $15 mil­lion in R&D cost off­set — to fund its mi­cro­bio­me plat­forms. It al­so rep­re­sent­ed the last of such li­cens­ing deals you’ll like­ly see from the French biotech in a while.

In the first fi­nanc­ing since 2017, En­terome has topped up its re­serves to $52.6 mil­lion (€46.3 mil­lion), most of which is go­ing to the first-in-hu­man stud­ies of its can­cer im­munother­a­py in re­cur­rent glioblas­toma and adren­al tu­mors.

Pierre Be­lichard

“It’s good to make deals, but it’s tak­ing time to the man­age­ment to han­dle the col­lab­o­ra­tion af­ter all,” CEO Pierre Be­lichard told End­points News. “And it was about time for us to ful­ly in­vest in­to our val­ue cre­ation for our share­hold­ers by prob­a­bly de­creas­ing the num­ber of deals and more de­vel­op­ing our in­ter­nal pipeline.”

Un­like some of the oth­er mi­cro­bio­me play­ers Take­da — and En­terome’s oth­er past part­ners such as Bris­tol My­ers Squibb and J&J, for that mat­ter — has en­list­ed, En­terome doesn’t di­rect­ly lever­age bac­te­ria from the gas­troin­testi­nal tract as drugs. Rather, it has over the years amassed a data­base of all the pro­teins and pep­tides se­cret­ed by the bac­te­ria from which to mine po­ten­tial treat­ments for dis­eases rang­ing from in­flam­ma­to­ry bow­el dis­ease and Crohn’s dis­ease to can­cer.

That means es­sen­tial­ly see­ing bac­te­ria as a provider of drugs or, in the case of its On­coMim­ic plat­form, bac­te­r­i­al anti­gens sim­i­lar to tu­mor-as­so­ci­at­ed anti­gens that can in­duce a spe­cif­ic im­mune re­sponse.

While pro­tect­ed in the GI tract, these mi­cro­bio­me-de­rived pep­tide anti­gens are iden­ti­fi­able by their epi­topes to mem­o­ry T cells such that once they are spot­ted in the blood, they ac­ti­vate a rapid im­mune at­tack, ac­cord­ing to the CEO.

“What we’re de­vel­op­ing is a way to in­duce a nev­er-seen-be­fore hu­man re­sponse which is di­rect­ed first to­wards the bac­te­r­i­al epi­tope, but in turn against the tu­mor and we hope­ful­ly will see in the clin­ic in­fil­tra­tion of the brain tu­mor or the adren­al tu­mor,” Be­lichard said.

EO2401, the lead as­set which com­bines three of these On­coMim­ic anti­gens, is be­ing test­ed in both the US and Eu­rope.

A sec­ond can­di­date, EO2463, is sched­uled to en­ter the clin­ic in 2021 for B-cell ma­lig­nan­cies such as lym­phomas and leukemias. Mean­while, En­terome is push­ing an un­part­nered hor­mone mimet­ic de­signed to in­duce se­cre­tion of IL-10 to treat IBD.

En­terome is al­so as­sist­ing Take­da in the proof-of-con­cept Crohn’s dis­ease tri­al for the FimH block­er si­bofim­loc.

Take­da par­tic­i­pat­ed in the Se­ries E along­side Sym­Bio­sis, a mi­cro­bio­me-fo­cused fund, and ex­ist­ing in­vestors Sev­en­ture, Health for Life Cap­i­tal, Prin­cip­ia, Omnes Cap­i­tal and Nestlé Health Sci­ence. Part of the funds comes from a loan pro­vid­ed by the Eu­ro­pean In­vest­ment Bank.

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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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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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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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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Douglas Love, Annexon CEO (Annexon)

IPO bound? A Bay Area biotech grabs a mega-round on the road to a piv­otal neu­rode­gen­er­a­tion pro­gram

South San Francisco-based Annexon has added $100 million to its cash reserves, along with a new roster of marquee investors backing their play on the classical complement pathway involved in neurodegeneration. And that may well fit the profile for an IPO — though right now everything seems to be working on that score.

Eighteen months after Bain and their syndicate partners put up $75 million to fuel clinical work, Annexon is back at the trough. And this time they’re adding Redmile Group for the lead role, with supporting investments from these new arrivals: BlackRock, Deerfield Management Company, Eventide Asset Management, Farallon Capital Management, Janus Henderson Investors and Logos Capital.

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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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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.

Josh Cohen, Justin Klee

Armed with pos­i­tive ALS da­ta, Amy­lyx scores $30M in fresh fund­ing to com­plete Alzheimer's PhII

Four years after announcing themselves to the biotech world with a new idea for drugging neurodegeneration, backing by the late Henri Termeer and $5 million from Morningside Venture, the young entrepreneurs at Amylyx are back for round 2.

Morningside continued to lead the $30 million Series B, with participation from Termeer’s widow, Belinda, and other unnamed investors. Having celebrated a topline Phase II win for its lead program in amyotrophic lateral sclerosis, Amylyx expects the cash to fund talks with regulators as well as a separate trial for the same drug in Alzheimer’s — for which they had just finished enrolling.