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.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Ep­i­darex, Sofinno­va dou­ble down on a par­al­lel take on 3rd-gen CAR-T — aim­ing straight at ovar­i­an can­cer

When John Maher treated the first head and neck cancer patient at Guy’s Hospital in London with his pan-ErbB CAR-T back in 2015, he was among a small club of researchers convinced they had an answer to the challenges that had kept those engineered T cells — wildly successful in hematological cancers — either too dangerous or out of reach for patients with solid tumors.

The field has blossomed since then, with a proliferation of technologies that promise to address any number of challenges identified as unique to solid tumors. And Maher himself has rethought his approach and come up with a new CAR-T platform to generate the next slate of candidates.