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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).

Federico Mingozzi (Spark)

Spark touts an­i­mal da­ta for a so­lu­tion to AAV gene ther­a­py's an­ti­body prob­lem

Among all the limitations of using an adeno-associated virus as a vector to deliver a gene — still the most established modality in gene therapy given years of trial and error and finally success — the presence of neutralizing antibodies, whether pre-existing or induced, looms large.

“When I think about the immune responses in AAV, I try to sort of layer them,” Federico Mingozzi, the CSO at Spark Therapeutics, told Endpoints News. “The antibody is the first layer. It’s the first block that you find when you’re trying to do gene transfer.”

IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO engine is thriving, never mind the rampage of the coronavirus crisis on R&D timelines.

On Friday, along with synthetic lethality-focused biotech Repare Therapeutics, another Bristol Myers partner Forma Therapeutics also unveiled its plans to vault on to the Nasdaq — penciling in a target of $150 million.

The Watertown, Massachusetts-based company — which poached senior Genentech executive Frank Lee to take over the reins last year after more than a decade under founder Steve Tregay — raised a plump $100 million late last year, while shepherding its sickle cell disease (SCD) drug through an early-stage trial.

Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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