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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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