Af­ter rais­ing $100M, Google-backed Evelo looks to blaze a new trail with mon­o­clon­al mi­cro­bials

Sim­ba Gill has al­ways want­ed, in his own words, “to build one great, ful­ly-in­te­grat­ed biotech com­pa­ny.”

And now he’s tak­ing his shot with Evelo Bio­sciences.

To­day, Gill and his crew of 50 are tak­ing the wraps off a $50 mil­lion in­vest­ment round, which brings the to­tal raised so far to $100 mil­lion. That’s enough mon­ey for Evelo — an ear­ly-stage com­bi­na­tion of two fledg­lings in­cu­bat­ed by Flag­ship Pi­o­neer­ing that were both tack­ling the same ob­jec­tive from op­po­site ends of the dis­ease spec­trum — to take a gi­ant step in­to the clin­ic with a slate of at least five pro­grams that will each look to demon­strate that a par­tic­u­lar mi­cro­bial strain can act to ac­cel­er­ate or brake an im­mune sys­tem at­tack.

It starts with can­cer, look­ing to open a new chap­ter in im­muno-on­col­o­gy that can fol­low the check­point pi­o­neers. And it goes off in­to a va­ri­ety of au­toim­mune con­di­tions and dis­ease types that Gill un­abashed­ly be­lieves will lay the ground­work for a rad­i­cal new ap­proach to drug de­vel­op­ment.

Flag­ship founder and CEO Noubar Afeyan

Any­one fa­mil­iar with Mod­er­na and the way Flag­ship’s Noubar Afeyan is build­ing com­pa­nies will rec­og­nize the mod­el in­stant­ly. The goal here is to pro­vide enough cash to prove a new plat­form tech can work pro­duc­ing key proof-of-con­cept da­ta.

“It’s re­al­ly start­ing to bear fruit,” says Kr­ish­na Yesh­want, the gen­er­al part­ner at GV — for­mer­ly Google Ven­tures — who is deeply im­pressed with Evelo’s pre­clin­i­cal ev­i­dence to back up the ther­a­peu­tic ef­fect of spe­cif­ic strains of gut mi­crobes – a far cry from the rather “vague” da­ta he’s seen be­hind the first wave of mi­cro­bio­me com­pa­nies in the clin­ic.

Kr­ish­na Yesh­want, GV

Make no mis­take, Gill and Yesh­want and all the back­ers are wait­ing to see what comes from the first wave of mi­cro­bio­me com­pa­nies in the clin­ic. But they clear­ly be­lieve that they’ve now reached the thresh­old where they can start to dis­tin­guish what they are af­ter com­pared to the ear­ly pi­o­neers in gut bi­ol­o­gy. Join­ing GV, Flag­ship and Cel­gene Ven­tures are the Mayo Clin­ic, al­ready strate­gi­cal­ly aligned with Evelo on the work, and Alexan­dria Ven­ture In­vest­ments.

“It is un­be­liev­ably clear that check­point in­hibitors are go­ing to be come se­mi-com­modi­tized,” Gill tells me about the first and sec­ond and third wave of PD-(L)1 in­hibitors now break­ing in­to the mar­ket. By tak­ing the lead on mon­o­clon­al mi­cro­bials in the gut, Evelo be­lieves it can clear­ly dis­tin­guish its own work while map­ping out an ear­ly-leader ad­van­tage in a brand new are­na of im­muno-on­col­o­gy.

It is, he adds, “at least as broad­ly ap­plic­a­ble as mon­o­clon­al an­ti­bod­ies and po­ten­tial­ly much broad­er.”

Those are bold words, and Gill says he’s ready to start back­ing it up with hard hu­man da­ta, look­ing for an ear­ly lead in on­col­o­gy and quick­ly ex­pand­ing the scope with drugs that tar­get im­muno-in­flam­ma­to­ry con­di­tions. Can­cer, he says, is an ob­vi­ous pick, but Gill and Evelo are keep­ing mum on their first shorts in au­toim­mune and au­to-in­flam­ma­to­ry con­di­tions  — for now.

“Our goal is for every sin­gle can­cer pa­tient to get a mon­o­clon­al mi­cro­bial,” says Gill. Along the way, he’s al­so ex­pect­ing some ma­jor col­lab­o­ra­tions with bio­phar­ma part­ners to fol­low.

Gill and his grow­ing crew still need to prove that what they are do­ing will work in hu­mans, as it has in mouse stud­ies, but they’re bet­ting $100 mil­lion that what they’ve seen so far proves it can be big.

It’s a big gam­ble, and one that Gill clear­ly rel­ish­es.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Laura Shawver (Silverback Therapeutics)

Fol­low­ing a hefty Se­ries B, Sil­ver­back Ther­a­peu­tics quick­ly pulls in $85M for 'an im­por­tant growth phase'

Months after reeling in a $78 million Series B round, Silverback Therapeutics has hooked an even larger Series C.

The Seattle-based company announced Wednesday that it netted $85 million from a slate of new and previous investors. The quick boost could be a sign that an IPO is on the way.

In an email, Silverback CEO Laura Shawver told me she was “not able to provide any additional comments about Silverback” beyond what was shared in the company’s news release. In the prepared statement, she said the company is at “an important growth phase.”

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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