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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.