Take­da joins mi­cro­bio­me-fo­cused biotech part­ner's $52.6M raise as it pur­sues more in-house can­cer work

A high-pro­file col­lab­o­ra­tion with Take­da back in late 2018 be­stowed up­on En­terome some phar­ma val­i­da­tion and sig­nif­i­cant cash — $50 mil­lion up­front and an­oth­er $15 mil­lion in R&D cost off­set — to fund its mi­cro­bio­me plat­forms. It al­so rep­re­sent­ed the last of such li­cens­ing deals you’ll like­ly see from the French biotech in a while.

In the first fi­nanc­ing since 2017, En­terome has topped up its re­serves to $52.6 mil­lion (€46.3 mil­lion), most of which is go­ing to the first-in-hu­man stud­ies of its can­cer im­munother­a­py in re­cur­rent glioblas­toma and adren­al tu­mors.

Pierre Be­lichard

“It’s good to make deals, but it’s tak­ing time to the man­age­ment to han­dle the col­lab­o­ra­tion af­ter all,” CEO Pierre Be­lichard told End­points News. “And it was about time for us to ful­ly in­vest in­to our val­ue cre­ation for our share­hold­ers by prob­a­bly de­creas­ing the num­ber of deals and more de­vel­op­ing our in­ter­nal pipeline.”

Un­like some of the oth­er mi­cro­bio­me play­ers Take­da — and En­terome’s oth­er past part­ners such as Bris­tol My­ers Squibb and J&J, for that mat­ter — has en­list­ed, En­terome doesn’t di­rect­ly lever­age bac­te­ria from the gas­troin­testi­nal tract as drugs. Rather, it has over the years amassed a data­base of all the pro­teins and pep­tides se­cret­ed by the bac­te­ria from which to mine po­ten­tial treat­ments for dis­eases rang­ing from in­flam­ma­to­ry bow­el dis­ease and Crohn’s dis­ease to can­cer.

That means es­sen­tial­ly see­ing bac­te­ria as a provider of drugs or, in the case of its On­coMim­ic plat­form, bac­te­r­i­al anti­gens sim­i­lar to tu­mor-as­so­ci­at­ed anti­gens that can in­duce a spe­cif­ic im­mune re­sponse.

While pro­tect­ed in the GI tract, these mi­cro­bio­me-de­rived pep­tide anti­gens are iden­ti­fi­able by their epi­topes to mem­o­ry T cells such that once they are spot­ted in the blood, they ac­ti­vate a rapid im­mune at­tack, ac­cord­ing to the CEO.

“What we’re de­vel­op­ing is a way to in­duce a nev­er-seen-be­fore hu­man re­sponse which is di­rect­ed first to­wards the bac­te­r­i­al epi­tope, but in turn against the tu­mor and we hope­ful­ly will see in the clin­ic in­fil­tra­tion of the brain tu­mor or the adren­al tu­mor,” Be­lichard said.

EO2401, the lead as­set which com­bines three of these On­coMim­ic anti­gens, is be­ing test­ed in both the US and Eu­rope.

A sec­ond can­di­date, EO2463, is sched­uled to en­ter the clin­ic in 2021 for B-cell ma­lig­nan­cies such as lym­phomas and leukemias. Mean­while, En­terome is push­ing an un­part­nered hor­mone mimet­ic de­signed to in­duce se­cre­tion of IL-10 to treat IBD.

En­terome is al­so as­sist­ing Take­da in the proof-of-con­cept Crohn’s dis­ease tri­al for the FimH block­er si­bofim­loc.

Take­da par­tic­i­pat­ed in the Se­ries E along­side Sym­Bio­sis, a mi­cro­bio­me-fo­cused fund, and ex­ist­ing in­vestors Sev­en­ture, Health for Life Cap­i­tal, Prin­cip­ia, Omnes Cap­i­tal and Nestlé Health Sci­ence. Part of the funds comes from a loan pro­vid­ed by the Eu­ro­pean In­vest­ment Bank.

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.