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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Watch out, Roche: No­var­tis inks $1.5B deal to chase down promi­nent Parkin­son’s tar­get

Novartis is plopping down $150 million in cash to pick up an experimental Parkinson’s drug and grab an option to another, a move that puts it on an increasingly popular path in the field’s search for disease-modifying therapies.

Belgium’s UCB is its partner of choice, supplying two small molecule alpha-synuclein misfolding inhibitors in a deal that can add up to nearly $1.5 billion.

Out of the pair, UCB0599 is already in Phase II trials, making Novartis confident enough to pull the trigger on co-development and commercialization, including to foot half of the R&D bill. The pharma giant will make a decision on UCB7853 once UCB wraps the ongoing Phase I program.

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Glax­o­SmithK­line, Ox­ford un­veil new part­ner­ship pit­ting buzzy R&D ad­vances against neu­ro­log­i­cal dis­ease

When GlaxoSmithKline trumpeted its return to neuroscience with a $700 million upfront deal with Alector this summer, it touted its early investments in functional genomics as a key guidepost for that deal. Now, the drug giant has partnered up with Oxford to hopefully add jet fuel to its hunt for breakthroughs in the brain.

GSK and Oxford have kickstarted a five-year collaboration aimed at spurring R&D breakthroughs across a range of hard-to-treat diseases like Alzheimer’s and Parkinson’s through the use of genomic testing and machine learning, the partners said Wednesday.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi snaps up new vac­cine can­di­date and de­vis­es mR­NA game plan around it — but not for what you think

Paul Hudson has spotlighted vaccines, immunology and dermatology as some of the top R&D focuses at Sanofi. His latest deal brings all of them together.

The French pharma giant isn’t sharing any financial details about the buyout of Origimm, a low-profile, private Austrian biotech whose technology promises to identify antigens causing skin disease and build vaccines against them. Their lead candidate targets acne vulgaris.

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