Not your mom’s pro­bi­ot­ic: GV-backed Evelo teams up with Mayo Clin­ic on mi­cro­bio­me drugs

Google Ven­tures-backed Evelo is join­ing forces with the Mayo Clin­ic to de­vel­op and even­tu­al­ly com­mer­cial­ize a fam­i­ly of gut bugs as med­i­cine.

You read that right. Evelo’s re­search is based on the idea that mi­crobes found in the gut can in­flu­ence bi­o­log­i­cal sys­tems through­out the rest of the body. If true, that means nat­u­ral­ly oc­cur­ring hu­man mi­crobes could po­ten­tial­ly be de­vel­oped as a new class of med­i­cine, the com­pa­ny’s CEO Sim­ba Gill tells me.

“What we have is a new modal­i­ty of med­i­cine that al­lows for oral, safe, con­ve­nient, and high­ly ef­fi­ca­cious drugs,” Gill said. “Sin­gle mi­crobes will act as med­i­cine to treat dis­ease.”

Mayo’s mi­crobes

Evelo calls these med­i­cine-wor­thy bugs “mon­o­clon­al mi­cro­bials,” and they’re not the on­ly ones in­trigued by their po­ten­tial phar­ma­co­log­i­cal us­es. The Mayo Clin­ic has been look­ing in­to this field for sev­er­al years, and re­cent­ly pub­lished da­ta in Cell and Arthri­tis and Rheuma­tol­ogy show­ing that pop­ping pills packed with cer­tain mi­cro­bials could sup­press mul­ti­ple scle­ro­sis and rheuma­toid arthri­tis. Mayo proved that in mice, and now Evelo wants to take the strain in­to the clin­ic.

The deal with Mayo gets Evelo a world­wide ex­clu­sive li­cense to the strains and sur­round­ing IP. The com­pa­ny did not dis­close the fi­nan­cial de­tails of the deal.

“This col­lab­o­ra­tion pro­vides us a new strain and fam­i­ly of mi­crobes backed by strong in­tel­lec­tu­al prop­er­ty,” Gill said. “Mayo has done great foun­da­tion­al work, and now we can rapid­ly take this fam­i­ly of mi­crobes in­to de­vel­op­ment by next year.”

Evelo isn’t di­vulging ex­act­ly which dis­eases it will take on first, but did say they’ll be look­ing in­to in­flam­ma­to­ry and neu­roin­flam­ma­to­ry dis­eases.

Evelo’s ex­ist­ing pipeline

As a com­pa­ny, Evelo emerged in 2016 by com­bin­ing two fledg­ling star­tups in­cu­bat­ed by Flag­ship Pi­o­neer­ing. Backed with $100 mil­lion from in­vestors in­clud­ing GV and Flag­ship, the com­pa­ny has been busy tak­ing on this am­bi­tious task of cre­at­ing a new drug modal­i­ty.

“What we’re do­ing is not straight for­ward,” Gill said. “Most peo­ple look at bal­anc­ing the gut ecosys­tem be­cause that’s the low hang­ing fruit. We went for the com­plex, more chal­leng­ing ap­proach. And that’s why we’re ahead of every­one else in this space.”

The new mi­crobes from Mayo add to Evelo’s ex­ist­ing vil­lage of mi­cro­bial fam­i­lies. The com­pa­ny is eval­u­at­ing how spe­cif­ic mi­crobes might in­flu­ence how the body’s im­mune sys­tem re­sponds to melanoma, re­nal and col­orec­tal can­cer, among oth­er dis­ease ar­eas. Gill was mum on ex­act­ly how many strains and pro­grams are on­go­ing, but said “sev­er­al” would en­ter the clin­ic next year.

The fu­ture of med­i­cine

Joseph Mur­ray

Gill has a rather bold pre­dic­tion that mon­o­clon­al mi­cro­bials will rev­o­lu­tion­ize med­i­cine.

“One of the rea­sons we’re so ex­cit­ed about this space is that — for many, many dif­fer­ent dis­eases — mon­o­clon­al mi­cro­bials could be used in com­bi­na­tion with or even dis­place bi­o­log­ics.”

And Mayo Clin­ic seems to agree.

“Our stud­ies show that hu­man de­rived mi­crobes can be used to treat mul­ti­ple im­muno­log­i­cal dis­eases well be­yond the gut,” said Joseph Mur­ray, pro­fes­sor of med­i­cine at Mayo Clin­ic.

Like the ad­vent of mon­o­clon­al an­ti­bod­ies, Gill be­lieves mon­o­clon­al mi­cro­bials will lead to a new wave of smarter drugs — more ef­fi­ca­cious, less tox­ic, and broad­ly ap­plic­a­ble to sev­er­al dis­ease ar­eas.

“Ef­fi­ca­cy, tox­i­c­i­ty, and con­ve­nience are the key at­trib­ut­es we’re look­ing at,” Gill said.

In those ar­eas so far, Gill said mon­o­clon­al mi­cro­bials’ per­for­mance is “strik­ing” in com­par­i­son to bi­o­log­ics.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,400+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

CymaBay flash­es pos­i­tive re­sults from the tri­al they have to re­launch

Two weeks after the FDA lifted its clinical hold on their lead drug, CymaBay said it showed positive results in an aborted Phase III trial.

The drug, a small molecule known as seladelpar, had been in development for three different liver conditions before an independent review of a NASH study last year showed that it might actually be damaging patient’s liver cells. The FDA slapped a clinical hold across all three trials, only lifting it last month when an FDA review determined that the drug hadn’t caused liver damage.

Sev­en plucky di­ag­nos­tics com­pa­nies win a $249M round of con­tracts af­ter sur­viv­ing NI­H's Covid-19 'Shark Tank' com­pe­ti­tion

As US Covid-19 deaths creep past 150,000 and officials stress the importance of contact tracing, the NIH’s Rapid Acceleration of Diagnostics (RADx) program has inked contracts totaling $248.7 million to expand testing capabilities.

The seven contracts, which were chosen “Shark Tank”-style from a pool of 100 proposals, are part of an effort to bump daily testing capacity to 2% of the country’s population by late summer or fall. That would be about 6 million people per day, compared to the current 520,000 to 823,000 tests being administered daily.

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.

Im­mu­nic's lead MS drug hits pri­ma­ry and key sec­ondary end­points in PhII, but ques­tions re­main

Just a week after its lead program began enrolling patients in a study to treat Covid-19, Immunic Therapeutics is making more waves.

This time, the biotech is providing a glimpse at topline data from a Phase II trial studying the efficacy of vidofludimus calcium, or IMU-838, in relapsing-remitting multiple sclerosis patients. Taken orally, the candidate met its primary endpoint in reducing the cumulative number of combined unique active MRI lesions after 24 weeks for a 45 mg dose compared to a placebo, as well as a key secondary endpoint in such reductions for the 30 mg dose.

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.

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.