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).

Amarin CEO John Thero discussing the company's plans for Vascepa, August 2019 — via Bloomberg

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

For all those people who could never quite believe that Amarin $AMRN would get an expanded label with blockbuster implications, the stress and anxiety on display right up to the last minute on Twitter can now end. But new, pressing questions will immediately surface now that the OK has come through.

On Friday afternoon, the FDA stamped its landmark approval on the industrial strength fish oil for reducing cardio risks for a large and well defined population of patients. The approval doesn’t give Amarin everything it wants in expanding its use, losing out on the primary prevention group, but it goes a long way to doing what the company needed to make a major splash. The approval was cited for patients with “elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.”

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Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

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Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

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Arie Belldegrun (Photo: Jeff Rumans for Endpoints News)

Ju­ry finds Gilead li­able for $585M and big roy­al­ties in Kite CAR-T patent case

A Kite deal that’s already become a burden on Gilead’s back just got heavier as a California jury has ruled Gilead must pay Bristol-Myers Squibb and Sloan Kettering $585 million plus a 27.6% royalty for patent infringement committed by its subsidiary. The ruling is almost certain to be appealed.

Kite Pharma — founded by Arie Belldegrun, now focused on a next-gen CAR-T company — has been facing a lawsuit since the day its first CAR–T therapy won approval in October, 2017. Juno Therapeutics and Sloan Kettering filed a complaint saying Kite had copied its technology. Gilead acquired Kite in June of that year for $11.9 billion.  Juno was acquired the following year by Celgene for $9 billion, before Celgene was acquired by Bristol-Myers Squibb in 2019.

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FDA ex­pert pan­el unan­i­mous­ly rec­om­mends ap­proval for Hori­zon Ther­a­peu­tics eye drug

An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).

“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

Paul Biondi (File photo)

Bris­tol-My­er­s' strat­e­gy, BD chief Paul Bion­di ex­it­ed the com­pa­ny — just ahead of the $74B Cel­gene deal close

Paul Biondi, who orchestrated billions of dollars in deals for Bristol-Myers Squibb over the 5 years he’s run their business development team, has exited the company. Biondi left last month, according to a company spokesperson, in pursuit of another — unspecified — external opportunity.

After 17 years with Bristol-Myers Squibb, Paul Biondi, Head of Strategy and Business Development, decided to leave the company to pursue an external opportunity. The company wishes him well in his new endeavors. Bristol-Myers Squibb  is actively searching for Paul’s successor, and will make an announcement, as appropriate.

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Arie Belldegrun at UKBIO 2019. Shai Dolev for Endpoints News

Kite Phar­ma's ex-CEO con­tra­dicts founder as CAR-T patent tri­al heats up, with con­flict­ing val­u­a­tions

Two days after Kite Pharma founder Arie Belldegrun told a federal courtroom that a meeting he had with a Memorial Sloan Kettering executive wasn’t about licensing their immunotherapy patent, Kite’s ex-CEO Aya Jakobovits said it was.

The admission came Tuesday during cross-examination in a patent infringement case that features two of the biggest cancer biotechs and some of the most well-known names in American medicine.

Jakobovits initially said she was not in attendance, didn’t know it was going to happen and didn’t know what took place, according to Law360. But then the plaintiff’s lawyer handed her a document – whose contents were not publicly revealed – and asked again if she learned after-the-fact that the meeting involved a potential patent license.

“Yes,” Jakobovits eventually said.

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On the heels of promis­ing MCL da­ta, Kite hus­tles its 2nd CAR-T to the FDA as the next big race in the field draws to the fin­ish line

Three days after Gilead’s Kite subsidiary showed off stellar data on their number 2 CAR-T KTE-X19 at ASH, the executive team has pivoted straight to the FDA with a BLA filing and a shot at a near-term approval.

In a small, 74-patient Phase II trial reported out at the beginning of the week, investigators tracked a 93% response rate with two out of three mantle cell lymphoma patients experiencing a complete response.

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