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).

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”