Jacques Ravel, via Ravel Lab

Biotech start­up joins quest to har­ness mi­cro­bio­me to un­teth­er re­liance on an­tibi­otics in wom­en's health

Har­ness­ing da­ta gath­ered as part of the Na­tion­al In­sti­tutes of Health (NIH) Hu­man Mi­cro­bio­me Pro­ject, the co-ed­i­tor-in-chief of the jour­nal Mi­cro­bio­me, Jacques Rav­el, has formed a biotech­nol­o­gy com­pa­ny fo­cused on women’s health.

The com­pa­ny, chris­tened Lu­ca Bi­o­log­ics, has leaned on 15 years of Rav­el’s vagi­nal mi­cro­bio­me re­search to de­vel­op a pipeline of ther­a­peu­tics de­signed to treat uri­nary tract in­fec­tions (UTI), preterm birth and bac­te­r­i­al vagi­nosis.

The WHO es­ti­mates that UTIs im­pact half of all women, and is the most com­mon bac­te­r­i­al in­fec­tion in the Unit­ed States. An­tibi­otics are the first and on­ly line of de­fense, but drug re­sis­tance has bur­geoned and su­per­bugs are all-per­va­sive. But the path to an­tibi­ot­ic ap­proval is long, ar­du­ous and ex­pen­sive — it of­fers lit­tle fi­nan­cial gain as treat­ments must be priced cheap­ly, and of­ten lose po­ten­cy over time as mi­crobes grow re­sis­tant to them. Mean­while, doc­tors pre­fer to use old­er, in­fi­nite­ly cheap­er an­tibi­otics in their first re­sponse, re­serv­ing fresh al­ter­na­tives for acute cas­es. Con­se­quent­ly, there has been no new class of an­tibi­otics ap­proved since the 1980s — and to­day, rough­ly 700,000 deaths an­nu­al­ly are at­trib­uted to drug-re­sis­tant bac­te­ria, ac­cord­ing to the WHO. Mean­while, the in­dus­try play­ers con­tribut­ing to the ar­se­nal of an­timi­cro­bials are fast dwin­dling as fee­ble sales frus­trate growth.

How­ev­er, last month the FDA sanc­tioned the ap­proval of Mer­ck’s $MRK com­bi­na­tion an­tibac­te­r­i­al for the treat­ment of com­pli­cat­ed uri­nary tract and in­tra-ab­dom­i­nal in­fec­tions.

Lu­ca’s mi­cro­bio­me-de­rived UTI tri­al is ex­pect­ed to be­gin en­rolling pa­tients this fall.

Lu­ca’s pipeline emerged from a vagi­nal mi­cro­bio­ta li­brary of 1,000+ strains and gene cat­a­log as­sem­bled by a re­search group led by Rav­el and fund­ed by the NIH and the Bill and Melin­da Gates Foun­da­tion. That da­ta were screened to iso­late genes that main­tain and pro­tect the sta­bil­i­ty of vagi­nal com­mu­ni­ties over time — and those in­sights were used to de­vel­op ex­per­i­men­tal com­pounds.

“While our re­search start­ed with metage­nom­ic se­quenc­ing to gen­er­ate large com­par­a­tive da­ta sets, we can now trans­late our find­ings in­to safe and ef­fec­tive treat­ments for wide­spread con­di­tions that stig­ma­tize and dev­as­tate mil­lions of women each year,” Rav­el said in a state­ment.

George Church Har­vard

Mi­cro­bial sci­ences com­pa­ny Seed Health, which counts Har­vard ge­neti­cist George Church and Rav­el on its sci­en­tif­ic ad­vi­so­ry board, spawned Lu­ca as part of its mis­sion to de­vel­op mi­cro­bial ther­a­pies for con­di­tions that are un­der­served by cur­rent stan­dard-of-care. Seed Health part­ners with sci­en­tists to pro­vide cap­i­tal in­vest­ment, reg­u­la­to­ry and IP guid­ance, bio-fer­men­ta­tion scale-up, and as­sis­tance with clin­i­cal tri­als through its aca­d­e­m­ic part­ner­ships.

Mi­cro­bio­me-based ther­a­peu­tics to­day is a fe­cund field for drug de­vel­op­ers — big and small — cap­i­tal­iz­ing on sci­ence that sug­gests flush­ing ‘good’ gut bac­te­ria in­to the sys­tem can treat a pletho­ra of con­di­tions — from C. diff in­fec­tions to obe­si­ty — us­ing dif­fer­ent ther­a­peu­tic modal­i­ties, some of which are de­signed to side­step the “ick” fac­tor as­so­ci­at­ed with tra­di­tion­al stool trans­fer or fe­cal mi­cro­bio­ta trans­plan­ta­tion (FMT).

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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FDA to Sarep­ta: Your wide­ly an­tic­i­pat­ed fol­lowup to Ex­ondys 51 is not get­ting an ac­cel­er­at­ed OK for Duchenne MD

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.

Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.