Bay­er fronts $65M Se­ries A for Metageno­mi, a gene ther­a­py biotech aim­ing to find new CRISPR en­zymes

Gene edit­ing is all the rage in biotech these days, with the field grow­ing in promi­nence es­pe­cial­ly af­ter this year’s No­bel Prize in Chem­istry was award­ed to two pi­o­neer­ing CRISPR sci­en­tists in Em­manuelle Char­p­en­tier and Jen­nifer Doud­na. And now, Bay­er’s in­vest­ment arm is go­ing all-in on a new gene edit­ing out­fit.

Leaps by Bay­er is co-lead­ing a $65 mil­lion Se­ries A round for Metageno­mi, a biotech launched by UC Berke­ley sci­en­tists that emerged from stealth on Thurs­day. Hum­boldt Fund is co-lead­ing the round with Leaps. Metageno­mi, which will be run by Berke­ley re­searcher Bri­an Thomas, is look­ing to de­vel­op a “tool­box” of both CRISPR- and non-CRISPR-based gene edit­ing sys­tems be­yond the Cas9 pro­tein typ­i­cal­ly seen in the field these days.

Bri­an Thomas

“The goal for Metageno­mi is re­al­ly to be able to do any type of gene edit­ing,” Thomas told End­points News. “Whether that be knock-ins or knock-outs that are com­pa­ra­ble to the cur­rent gene edit­ing ca­pa­bil­i­ties, but al­so to be able to do base edit­ing through an en­gi­neer­ing ca­pa­bil­i­ty, as well as to be able to in­te­grate larg­er pieces of DNA that will al­low us to pro­vide safer gene edit­ing.”

Oth­er in­vestors in the Se­ries A in­clud­ed So­zo Ven­tures, Agent Cap­i­tal, In­Cube Ven­tures and HOF Cap­i­tal.

Dur­ing his time at Berke­ley, Thomas was work­ing in the lab of Jill Ban­field, Metageno­mi’s sci­en­tif­ic co-founder, whose re­search fo­cused on find­ing new CRISPR en­zymes in ex­ot­ic bac­te­ria. Now at Metageno­mi, Thomas’ goal is to ap­ply ma­chine learn­ing on a broad scale to mine through the genomes of these mi­croor­gan­isms, search­ing for new nu­cle­as­es that can be used in gene ther­a­pies.

Thomas says the com­pa­ny has found over 100 po­ten­tial en­zymes in the past year as it’s been build­ing out its data­base in stealth. The main ad­van­tage of these sys­tems, Thomas said, is that many — if not all — are much small­er than Cas9, with some be­ing less than half the size. That would al­low for much more pre­cise med­i­cines that lim­it the off-site tox­i­c­i­ty some­times seen with cur­rent gene ther­a­pies.

“The en­zymes we have are re­al­ly able to out­per­form the cur­rent sys­tems in terms of edit­ing ef­fi­cien­cy,” Thomas said. “We’re get­ting edit­ing ef­fi­cien­cies at greater than 90% and some­times greater than 95%.”

It re­al­ly comes down to the sci­ence of metage­nomics, from which Metageno­mi gets its name, Thomas said. Go­ing be­yond ge­nomics, where you start with a lab cul­ture, metage­nomics in­stead looks at the ge­net­ic ma­te­r­i­al re­cov­ered from soil, which con­tains the thou­sands of or­gan­isms that Metageno­mi hopes to map out.

Juer­gen Eck­hardt

Thomas proved so suc­cess­ful at pitch­ing his com­pa­ny, he poached away one of Leaps’ ex­ec­u­tives to be Metageno­mi’s chief busi­ness of­fi­cer. De­spite that, Bay­er is par­tic­u­lar­ly ex­cit­ed about this start­up and Leaps chief Juer­gen Eck­hardt be­lieves Metageno­mi could be at the fore­front of the next gen­er­a­tion of gene edit­ing.

“You look at gene edit­ing and you have these first-wave com­pa­nies, they are all based on one de­tail: CRISPR Cas9,” Eck­hardt said. “What Metageno­mi has, they are sit­ting on thou­sands of nu­cle­as­es that will have a range of fea­tures that may be op­ti­mized for what CRISPR can’t be able to do. I think that’s why this is the next two, three, four, five waves of gene edit­ing are right here.”

Metageno­mi is still an ear­ly-stage com­pa­ny and Thomas isn’t di­vulging what kinds of drugs they’re aim­ing to de­vel­op as of yet, but not­ed a broad in­ter­est in can­cers and im­muno-on­col­o­gy. On top of that, Metageno­mi’s en­zymes would still need to be paired up with a de­liv­ery sys­tem to get the ther­a­py where it needs to go.

But for now, Metageno­mi will keep plug­ging away in or­der to val­i­date its tech­nol­o­gy. Thomas said that, as a bio­chemist, it’s ex­cit­ing to look at some of these or­gan­isms that have nev­er been seen un­der a mi­cro­scope be­fore that po­ten­tial­ly hold the key to the next cell ther­a­pies.

“Metage­nomics is a very pow­er­ful sci­ence, and I think Metageno­mi is a clear leader in us­ing that sci­ence to de­vel­op and tap in­to this avail­able, nat­ur­al cel­lu­lar ma­chin­ery out there that can be used,” Thomas said. “We’re ex­cit­ed about what na­ture has to of­fer as we dig deep­er in­to this dataset.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.