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).

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”