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.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”