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.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can created herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

Rich Heyman (ARCH)

Rich Hey­man joins PMV Phar­ma, a p53 biotech, as it adds $70 mil­lion in Se­ries D

Less than a year after pulling in an impressive $62 million Series C round, PMV Pharma is back at it again.

The Cranbury, NJ-based biotech announced Monday an additional $70 million in Series D financing as it seeks to develop cancer therapies targeting p53 mutations. Additionally, PMV also introduced longtime biotech entrepreneur Rich Heyman as chairman of the board of directors.

“This financing provides PMV Pharma with the resources to expand our pipeline and to potentially advance multiple p53 therapies into the clinic,” said PMV president and CEO David Mack in a statement.

Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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Tony Coles, Cerevel Therapeutics CEO

Adding $445M, Tony Coles and his big Pfiz­er neu­ro spin­out hitch a ride to Wall Street on Per­cep­tive’s SPAC

Two years ago, after Pfizer abruptly shut down its entire neuroscience division, Bain Capital bet $350 million that those assets were still worth something and packaged them into a new biotech: Cerevel Therapeutics. A year later, they got seasoned executive Tony Coles, who had recently jumped back into the C-suite of another neuroscience startup, to run the company.

Now Coles is steering Cerevel public, in what he says is the largest ever transaction of its kind. Cerevel has agreed to merge with Perceptive Advisors’ specialty acquisition company ARYA II. Between the roughly $125 million Perceptive raised through ARYA and an additional investment of $320 million Bain Capital, Perceptive and — yes, really — Pfizer, among others, Cerevel will now move forward with an added $445 million in its coffers.

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Sanofi un­der for­mal in­ves­ti­ga­tion for De­pakine al­le­ga­tions; Beam li­cens­es CAR-T tech from Ox­ford Bio­med­ica

Sanofi is facing a formal investigation on manslaughter charges, due to accusations that its epilepsy drug Depakine caused birth malfunctions and slow neurological development when taken during pregnancy.

The French pharma was formally charged in February, years after evidence surfaced that the drug, sodium valproate, posed neurodevelopmental risks. Sodium valproate first hit the market in 1967 for the treatment of epilepsy and bipolar disorder, and is currently prescribed in more than 100 countries.

Days af­ter seal­ing Sanofi pact, Kymera beats a path to the Nas­daq with $100M IPO pitch

Back in March, when Kymera Therapeutics closed $102 million in Series C funding led by Biotechnology Value Fund and Redmile Group, CEO Nello Mainolfi noted the protein degradation player was “at the cusp of transitioning” into a fully integrated R&D company. Five months and a major Sanofi pact later, he’s back asking for another little push to get there.

Kymera has penciled in $100 million in its first IPO pitch — although given the public market’s seemingly insatiable appetite for biotechs these days the final figure is anyone’s guess.