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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.