Adap­ti­m­mune pledges $312M for Noile-Im­mune's T cell boost­ing tech in dri­ve to de­liv­er on TCR promise

When Adri­an Raw­cliffe of­fi­cial­ly steps in­to the CEO role at Adap­ti­m­mune in a few days, he will have a new part­ner­ship to ex­e­cute in one of his first ef­forts to shore up some en­thu­si­asm for its T cell ther­a­py pro­grams.

Adri­an Raw­cliffe

In a $312 mil­lion pact, the US-UK hy­brid biotech has en­list­ed Noile-Im­mune for a next-gen­er­a­tion project that will boost Adap­ti­m­mune’s SPEAR T cells with the Japan­ese com­pa­ny’s PRIME plat­form. In ad­di­tion to the re­cep­tors en­gi­neered in­to the T cells, the re­sult­ing prod­uct would be armed with the cy­tokines IL-7 and CCL19.

Noile-Im­mune has been ap­ply­ing their tech­nol­o­gy — in­vent­ed by Ko­ji Tama­da of Ya­m­aguchi Uni­ver­si­ty — to CAR-T cells, pre­vi­ous­ly ink­ing a co-de­vel­op­ment deal with Take­da.

Not on­ly does PRIME make the en­gi­neered cells more po­tent, it may al­so en­hance the abil­i­ty of the pa­tient’s na­tive T cells to fight sol­id tu­mors, ac­cord­ing to Karen Miller, Adap­ti­m­mune’s SVP of pipeline re­search.

Karen Miller

“We re­cent­ly start­ed our Phase 2 tri­al in sar­co­ma called SPEAR­HEAD-1 as well as the SUR­PASS tri­al, our first next-gen­er­a­tion prod­uct clin­i­cal tri­al. We will con­tin­ue to de­vel­op en­hanced prod­ucts with the aim of in­creas­ing the ef­fi­ca­cy and dura­bil­i­ty of an­ti-tu­mor re­spons­es,” she added in a state­ment.

It’s crunch time for Adap­ti­m­mune. Once a dar­ling in the I/O crowd with a bud­ding TCR tech, its sup­port on Wall Street has been wan­ing since its $191 mil­lion pub­lic de­but in 2015, which in turn fol­lowed a high pro­file $350 mil­lion col­lab­o­ra­tion with Glax­o­SmithK­line. The stock opened at $1.47 to­day, a pre­cip­i­tous fall from last fall’s peak of $13.9. As founder James No­ble pass­es the reins to CFO Raw­cliffe — a GSK vet — the theme now is to make things hap­pen.

Adap­ti­m­mune will now work with Noile-Im­mune on pre­clin­i­cal work around a num­ber of tar­gets, with a goal to en­ter the clin­ic by 2021. That will all hap­pen un­der a new CMO and R&D pres­i­dent af­ter Rafael Ama­do hit the ex­it ear­li­er this month.

At last count the com­pa­ny had about $35 mil­lion in cash on hand and $133 mil­lion in liq­uid­i­ty, giv­ing it a run­way that ex­tends in­to the third quar­ter of next year.

So­cial im­age cred­it: Navy Yard

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Jim Tananbaum, Foresite

Fore­site re­turns to the SPAC well, as in­vestors won­der how long the run can last

Six months after launching his first biotech SPAC, Foresite’s Jim Tananbaum has started a second. On Tuesday, the longtime life science investor filed to raise $100 million by selling 10 million shares of the blank check company FS development II.

It’s a quick return to Wall Street for Foresite, although other firms have moved quicker. Perceptive Advisors raised a $130 million SPAC in June and were back before the end of July to raise another $125 million. By that point, the firm was evidently nearing a deal for the June SPAC, which would announce a half-billion-dollar merger with Cerevel Therapeutics on July 30.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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