Take­da dou­bles down on Finch's mi­cro­bio­me in­sights, sign­ing up for a sec­ond project in Crohn's dis­ease

Take­da first shone a spot­light on Finch Ther­a­peu­tics’ hu­man-first dis­cov­ery plat­form in 2017, when the Japan­ese phar­ma paid $10 mil­lion to part­ner a pre­clin­i­cal ul­cer­a­tive col­i­tis pro­gram in­spired by fe­cal trans­plan­ta­tion. While the mi­cro­bio­me ther­a­py, FIN-524, is still mak­ing its way to the clin­ic, Take­da has seen enough to com­mit to a sec­ond pro­gram tack­ling an­oth­er type of in­flam­ma­to­ry bow­el dis­ease.

Mark Smith

The duo will now rev up Finch’s plat­form tech again in search of a treat­ment for Crohn’s dis­ease, which Take­da will have ex­clu­sive rights to com­mer­cial­ize. Fi­nan­cial terms were not dis­closed.

De­ploy­ing ma­chine learn­ing to crawl through da­ta from in­ter­ven­tion­al mi­cro­bio­ta trans­plan­ta­tion stud­ies, Finch CEO Mark Smith aims to iden­ti­fy mean­ing­ful mi­cro­bial sig­na­tures por­tend­ing dis­ease. The re­sult is what he calls ra­tio­nal­ly-se­lect­ed mi­cro­bio­ta ther­a­pies, which con­tain cul­tured bac­te­r­i­al strains linked to pos­i­tive clin­i­cal out­comes.

That ap­proach could prove su­pe­ri­or to an­i­mal mod­els, Finch the­o­rizes. FIN-524 was their first at­tempt to val­i­date the the­o­ry — as the two oth­er can­di­dates in their pipeline, for re­cur­rent C. diff and autism, came from its oth­er dis­cov­ery plat­form. Known as full-spec­trum mi­cro­bio­ta, it rep­re­sents the foun­da­tion­al “drugs from bugs” idea of putting good bac­te­ria in a pill.

Gareth Hicks

“We’ve seen the promise of Finch’s Hu­man-First Dis­cov­ery plat­form for the de­vel­op­ment of a com­plete­ly new type of treat­ment for in­flam­ma­to­ry bow­el dis­ease,” said Gareth Hicks, head of gas­troen­terol­o­gy drug dis­cov­ery unit at Take­da, in a state­ment.

Hicks is in charge of one of four core ther­a­peu­tic ar­eas that Take­da is ze­ro­ing in on in the wake of the Shire ac­qui­si­tion (the oth­er three be­ing on­col­o­gy, neu­ro­science and rare dis­eases). Right now, one of the stars in the port­fo­lio is En­tyvio, an IBD drug that blocks the bind­ing of α₄β₇ in­te­grin to in­testi­nal mu­cos­al ad­dressin cell ad­he­sion mol­e­cule 1 (MAd­CAM-1), there­by ame­lio­rat­ing the in­flam­ma­to­ry ef­fect of white blood cells on gut tis­sues.

The col­lab­o­ra­tion with Finch isn’t their on­ly push in­to the nascent but fe­cund field of mi­cro­bio­me-based ther­a­peu­tics. Last Oc­to­ber Take­da put down $50 mil­lion to team up with France’s En­terome on EB8018, a small mol­e­cule de­signed to se­lec­tive­ly dis­arm vir­u­lent bac­te­ria in the gut caus­ing in­flam­ma­tion, with­out dis­rupt­ing the lo­cal mi­cro­bio­me.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

‘Plan­ning to vac­ci­nate every­one in the US,’ Mod­er­na out­lines ef­forts to sup­ply their Covid-19 vac­cine as man­u­fac­tur­ing ramps up ahead of PhI­II

Twelve days from the planned start of their Phase III pivotal trial, the executive crew at Moderna has set up the manufacturing base needed to begin production of the first 500,000 doses of their Covid-19 vaccine with plans to feed it into a global supply chain. But the initial batches will likely be ready in the US first, where company CEO Stéphane Bancel plans to be able to vaccinate everyone.

“We have started making commercial product at-risk, and will continue to do so every day and every week of the month,” Bancel told analysts during their morning call on the Phase I data just published in the New England Journal of Medicine.

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Covid-19 roundup: Vac­cine by end of 2020? Ken Fra­zier warns hype do­ing 'grave dis­ser­vice'

When it comes to setting expectations about a Covid-19 vaccine, Ken Frazier does not mince words.

Over a month after first casting doubts on the aggressive 12- to 18-month timeframe championed by the US government and his biopharma peers, the Merck CEO again cautioned against any hype around a quick vaccine approval.

In a wide-ranging interview with Harvard Business School professor Tsedal Neeley that touched other big topics such as race, Frazier emphasized that vaccines take a long time to develop. He would know: Out of the seven new vaccines introduced around the world in the past 25 years, four came from Merck.

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Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

A top an­a­lyst turns the spot­light on Mod­er­na, fu­el­ing a fast-and-fu­ri­ous Street race over the fu­ture of mR­NA

Bioregnum Opinion Column by John Carroll

Four months ago, one of the favorite talking points on the biopharma social media wave length was whether Moderna shares $MRNA were priced right or were wildly inflated.

After all, said the naysayers, the company had never actually pushed a treatment to an approval. Did messenger RNA really work, coding cells to make a drug or a vaccine? And how about all that chatter about how ‘secretive’ they are, or were?

Now, as CEO Stéphane Bancel and the top execs push the company to the forefront of a frantic race to develop the first vaccine to fight against the reignited wildfire spread of Covid-19, all those questions have been magnified — along with the stock price.

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Ludwig Hantson, Alexion CEO

Why pay $4B for a steady di­et of dis­ap­point­ment? Porges turns thumbs down on Alex­ion’s M&A strat­e­gy, of­fers some point­ers

When Alexion announced recently that it was paying $1.4 billion to bag Portola and its underperforming Factor Xa inhibitor reversal agent, you could hear the head-scratching going on around virtual Wall Street.

Why was Alexion going down the discount lane for new products? And why something like this? Analysts have been urging Alexion to get serious about M&A for years if it was serious about diversifying the company beyond Soliris and its successor drug. But this wasn’t the kind of heavy-impact deal they were looking for.

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