Mike Romanos, Microbiotica CEO

Look­ing to push check­point ef­fi­ca­cy, a qui­et mi­cro­bio­me up­start bags $67M for clin­i­cal work

Mi­cro­bi­ot­i­ca has some more funds to work with — $67 mil­lion more.

The qui­et mi­cro­bio­me ther­a­peu­tics spin­out with 48 em­ploy­ees an­nounced its Se­ries B ear­li­er this morn­ing, which was co-led by Swedish in­vestor Flerie In­vest along­side Chi­nese multi­na­tion­al con­glom­er­ate Ten­cent. Oth­er in­vestors hopped on­to the round, in­clud­ing new in­vestor British Pa­tient Cap­i­tal and ex­ist­ing in­vestors Cam­bridge In­no­va­tion Cap­i­tal, IP Group, and Sev­en­ture Part­ners.

Mi­cro­bi­ot­i­ca chief Mike Ro­manos told End­points News that the raise from the se­ries round will last the biotech about three years. And in terms of an IPO, the com­pa­ny is in­ter­est­ed, and “it’s on our minds,” Ro­manos said. But as far as a time­line or lo­ca­tion, that re­mains to be seen.

The out­fit orig­i­nal­ly start­ed up out of the Well­come Sanger In­sti­tute in the UK back in 2016 to fo­cus more on mi­cro­bio­me sci­ence, and since then it has kept its part­ner­ships most­ly aca­d­e­m­ic, with the ex­cep­tion of Roche sub­sidiary Genen­tech. And so far, the biotech has been look­ing in­to two things: 1) bio­mark­ers for drug re­sponse, drug side ef­fects or dis­ease pro­gres­sion; and 2) live bac­te­r­i­al ther­a­peu­tics, a cat­e­go­ry of treat­ments that is ba­si­cal­ly hu­man and mi­cro­bial liv­ing cells se­lect­ed, mod­i­fied, or en­gi­neered to treat/cure dis­ease.

And in the case of Mi­cro­bi­ot­i­ca, its two lead can­di­dates fit this cat­e­go­ry — uti­liz­ing spe­cif­ic bac­te­ria in a cap­sule to un­der­go tar­get­ed re­lease in a pa­tient.

As to where the mon­ey is head­ed, Mi­cro­bi­ot­i­ca will be push­ing its lead can­di­dates in­to Phase Ib ear­ly next year. The first drug, MB097, is a pa­tient re­sponse boost­er for im­mune check­point in­hibitor ther­a­pies, aka Keytru­da, Op­di­vo, Yer­voy and Tecen­triq.

Ro­manos said that the com­pa­ny had no­ticed in­creased lev­els of cer­tain bac­te­ria in pa­tients that re­spond­ed to cer­tain check­point in­hibitors, and then looked in­to whether or not those bac­te­ria, when giv­en to pa­tients, could in­crease re­sponse rates to these check­point in­hibitor drugs.

“We took those bac­te­ria, and we found that hey, presto, they stim­u­late im­mune cells from hu­mans, from donors in the test tube, ul­ti­mate­ly to kill tu­mors in the test tube,” Ro­manos said. “So we think that they are in­volved in con­trol­ling the im­mune sys­tem and stim­u­lat­ing it so that the cy­to­tox­ic T cells and oth­er cells can kill the tu­mors.”

The oth­er can­di­date, MB310, is an LBT with cer­tain types of bac­te­ria to treat ul­cer­a­tive col­i­tis (UC). Those bac­te­ria that were iden­ti­fied and part of the can­di­date have been po­ten­tial­ly linked to re­mis­sion in fe­cal trans­plant stud­ies, ac­cord­ing to Mi­cro­bi­ot­i­ca.

The funds will al­so be used to ex­pand Mi­cro­bi­ot­i­ca’s dis­cov­ery pipeline of bio­mark­ers and LBTs in new dis­ease ar­eas. Mi­cro­bi­ot­i­ca al­so has two more ear­ly-stage LBT can­di­dates in its pipeline, one for ep­ithe­lial gut wall re­pair and an­oth­er for a “nov­el dis­ease area.” And while Ro­manos wouldn’t say ex­act­ly what dis­ease the com­pa­ny is want­i­ng to go af­ter, he did say that it’s in the realm of meta­bol­ics.

Ro­manos al­so said that while peo­ple talk about the clin­i­cal fail­ures that have faced mi­cro­bio­me treat­ments in the past (such as the FDA slap­ping a hold on Finch’s mi­cro­bio­me C. dif­fi­cile treat­ment last week), he thinks all the pieces are there for mi­cro­bio­me treat­ments to ex­pand.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Endpoints Premium

Premium subscription required

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

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Shehnaaz Suliman, ReCode Therapeutics CEO (Photo by Jennifer Leahy)

Pfiz­er, Sanofi-backed LNP out­fit goes back to the well and draws $120M for its trek to the clin­ic

A preclinical biotech touting a five-lipid drug delivery platform is looking to break out of its preclinical mold, and it just secured a sizable raise to do just that.

ReCode Therapeutics reported Wednesday morning that Leaps by Bayer and Matrix Capital Management affiliate AyurMaya co-led a Series B extension round, adding $120 million to the biotech’s previous Series B haul of $80 million. The biotech has been backed by several players in Big Pharma, notably Pfizer and Sanofi from its original Series B close last fall. And in this extension — featuring all new investors, CEO Shehnaaz Suliman tells Endpoints News — Amgen’s VC arm jumped on board.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Eliot Charles, MiroBio executive chairman

Ox­ford spin­out nabs al­most $100M in new cash to test PD-1 in au­toim­mune dis­eases and hunt for a CEO

After about 15 years in an Oxford lab and three more years in the upstart world following a 2019 spinout, MiroBio is ready to enter UK clinical trials and, en route to the clinic, the biotech has picked up $97 million in Series B funds.

The £80 million financing round kicked off in earnest last September and includes a transatlantic consortium — led by Medicxi — ready to bankroll that first clinical trial, beginning “imminently,” as well as the debut study of a second program thereafter, executive chair Eliot Charles, an SR One venture partner, told Endpoints News.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.