$42M in, Flag­ship star­tups merge in­to one im­muno-mi­cro­bio­me plat­form with mul­ti­ple tar­gets

What hap­pens when you com­bine two star­tups with a nov­el take on revving up and slow­ing down the im­mune sys­tem? You get a new com­pa­ny called Evelo Bio­sciences with its own twist on two hot fields: im­muno-on­col­o­gy and the mi­cro­bio­me.

Sim­ba Gill, Evelo CEO, cour­tesy of Flag­ship Ven­tures

“We each ID’d bac­te­ria and bac­te­r­i­al com­bi­na­tions hav­ing a pro­found im­pact on the im­mune sys­tem, but from dif­fer­ent di­rec­tions,” says Sim­ba Gill, the CEO of the com­bined op­er­a­tion, which is fold­ing the small­er Epi­va Ther­a­peu­tics in­to Evelo. Both were seed com­pa­nies start­ed in Flag­ship Ven­ture­Labs, spend­ing more than two years in stealth mode un­der the VC’s wing, where Gill is al­so a part­ner on the ven­ture side.

The new Evelo is both big­ger and fur­ther along on the pre­clin­i­cal side than it may sound at first blush. The com­bined com­pa­ny now has 42 staffers, with $40 mil­lion of com­mit­ted fi­nanc­ing and enough left to get 12 to 18 months down the road, says the CEO.

That’s enough time to get at least two pro­grams in­to the clin­ic next year; ide­al­ly in­clud­ing one aim­ing at a new ap­proach to im­muno-on­col­o­gy with the oth­er in the au­toim­mune/in­flam­ma­to­ry are­na. It’s al­so enough time to put to­geth­er an­oth­er syn­di­cate for the next round of fi­nanc­ing, look­ing be­yond Flag­ship’s deep pock­ets for some added R&D mon­ey.

It sim­ply made sense to com­bine the start­up in­to one or­ga­ni­za­tion, says Gill. Aim­ing to cre­ate “the de­fin­i­tive com­pa­ny in the space,” as he puts it, both com­pa­nies had been work­ing in­de­pen­dent­ly on sim­i­lar plat­form ca­pa­bil­i­ties. It’s not easy run­ning a cell-based as­say on anaer­o­bic bac­te­ria, he notes, and bring­ing the groups to­geth­er cre­ates some nice syn­er­gies to im­prove the work and broad­en the plat­form to a long list of po­ten­tial pro­grams reach­ing across mul­ti­ple can­cers and au­toim­mune/in­flam­ma­to­ry con­di­tions.

It al­so helped that Gill, Flag­ship chair­man Noubar Afeyan, and fel­low part­ner David Berry all had the same line of sight view on the po­ten­tial, for a com­pa­ny in which Flag­ship still con­trols all of the skin in the game.

Mark Pruzan­s­ki, the co-founder and CEO of In­ter­cept Phar­ma­ceu­ti­cals, David Per­ry, CEO and pres­i­dent of In­di­go Agri­cul­ture, are join­ing Afeyan, Gill, and Berry on the board. Com­ing on staff is Jack­ie Pap­koff, se­nior vice pres­i­dent, re­search, new CMO Anil Ji­na and Derek Adams, se­nior vice pres­i­dent, CMC.

From here you can ex­pect the com­pa­ny to start mak­ing the kind of clas­sic moves you’d ex­pect from a biotech start­up: in­dus­try part­ner­ships for some nondi­lu­tive fund­ing and added R&D sup­port, a broad­er base of back­ers and some ear­ly op­por­tu­ni­ties to es­tab­lish that you’re on the right track.

That’s still a risky propo­si­tion, but Gill says Evelo has the po­ten­tial to “go all the way.”

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

From left: James Brown, Michael Chambers, John Ballantyne

Alde­vron founders back a biotech start­up that's look­ing to end the moral de­bate over cell lines once and for all

For millions of Catholics around the world, the development of new vaccines to combat Covid-19 has sparked a moral dilemma. All the approved vaccines in use relied — in some fashion — on cell lines that were derived from aborted fetal tissue.

While church leaders accepted the vaccines and recommended their use to end the pandemic, a number also highlighted their preference for the mRNA vaccines from Pfizer/BioNTech and Moderna over the J&J and AstraZeneca shots, which they noted were more heavily dependent on cell lines that they found morally objectionable.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”