Ara Katz (L) and Raja Dhir (Seed)

On the hunt for bugs out­side the gut, Seed Health snares $40M round to ad­vance pipeline with the help of George Church

In 2017, as “mi­cro­bio­me ma­nia” was set­ting in, Ra­ja Dhir and Ara Katz launched Seed Health to go broad where oth­ers went small. While most oth­er play­ers fo­cused on the gut, Dhir said, Seed set out to un­der­stand mi­cro­bial com­mu­ni­ties in the gut and else­where, such as in the mouth or on the skin.

“Most peo­ple don’t know that cav­i­ties are the most com­mon bac­te­r­i­al in­fec­tion in the world,” he said.

On Wednes­day, the LA-based biotech — ad­vised by famed Har­vard sci­en­tist George Church — un­veiled a $40 mil­lion Se­ries A round to con­tin­ue the hunt for in­no­va­tions and ther­a­pies that uti­lize ecolo­gies of nat­u­ral­ly oc­cur­ring bac­te­ria.

“Be­yond the gut, there’s mi­cro­bial com­mu­ni­ties which still are un­der­stud­ied and poor­ly de­fined, and in­ter­ven­tion­al tri­als and in­ter­ven­tion­al da­ta [are] lack­ing,” Dhir told End­points News. “So that’s the first re­al push, or dif­fer­en­ti­a­tion, or op­por­tu­ni­ty that we see.”

Pri­or to launch­ing Seed, Katz worked in con­sumer tech. She co-found­ed a mo­bile com­merce start­up called Spring, where she helped launch Ap­ple Pay for iPhone. Then when she got preg­nant, she be­came in­ter­est­ed in the im­pact of mi­crobes on health and the en­vi­ron­ment. She met Dhir, an en­tre­pre­neur who had de­signed clin­i­cal tri­als with aca­d­e­m­ic in­sti­tu­tions like Har­vard Med­ical School and Mass­a­chu­setts Gen­er­al Hos­pi­tal, and the two clicked. Dhir knows Church and in­vit­ed him on board as one of the com­pa­ny’s first ad­vi­sors.

The biotech’s flag­ship DS-01, a 24-strain pro­bi­ot­ic, is cur­rent­ly in a Phase II tri­al for ir­ri­ta­ble bow­el syn­drome (IBS), and is al­so be­ing stud­ied for con­sti­pa­tion, post-al­co­hol gut mi­cro­bio­ta restora­tion, urolithin pro­duc­tion and re­cov­ery af­ter broad-spec­trum an­tibi­otics.

The com­pa­ny al­so has a live bio­ther­a­peu­tic for uri­nary tract in­fec­tion (UTI) that’s ex­pect­ed to en­ter a Phase II tri­al in the US lat­er this year in part­ner­ship with Lu­ca Bi­o­log­ics, which Seed spun out back in 2019. Con­cur­rent with that study will be a Phase Ib and Phase II in bac­te­r­i­al vagi­nosis, Dhir ex­plained.

Sci­en­tists at Seed start with sin­gle strains of bac­te­ria from a mas­ter cell bank, then cul­ti­vate them in iso­la­tion and re­con­sti­tute them in vary­ing ra­tios to build en­tire ecolo­gies of bac­te­ria that are crit­i­cal to pre­vent­ing cer­tain in­fec­tions. The com­pa­ny is al­so work­ing on pro­grams for high cho­les­terol, ma­jor de­pres­sive dis­or­der and spon­ta­neous preterm birth.

In 2018, the com­pa­ny launched Seed­Labs to de­vel­op mi­cro­bial so­lu­tions for en­vi­ron­men­tal chal­lenges — in­clud­ing pro­bi­otics for bees and corals.

“I am in­spired by Seed’s bold vi­sion to fer­ment the fu­ture, us­ing mi­crobes to re­think health,” Church, al­so a Seed­Labs ad­vi­sor, said in a state­ment.

Ear­li­er this year, Seed ac­quired Aug­gi, an AI start­up that an­a­lyzes pho­tos of stool sam­ples. Seed says it will use the tech­nol­o­gy to launch a prod­uct that can mon­i­tor gas­troin­testi­nal health.

“I think there’s such an op­por­tu­ni­ty with dig­i­tal health and es­pe­cial­ly in a post-Covid world, a push to­wards de­cen­tral­iza­tion of med­ical records as well as med­ical treat­ment and di­ag­no­sis,” Dhir said. “It’s the first of a se­ries of dig­i­tal health ini­tia­tives that we have here at Seed.”

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.