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

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

No­var­tis’ CAR-T part­ner in Chi­na wraps $383M take-pri­vate deal en­gi­neered by CEO

After 13 years on Nasdaq, Cellular Biomedicine Group is returning to private hands.

CEO Tony (Bizuo) Liu is a key advocate of the deal, leading a consortium of mostly Chinese investors including other top company execs, Yunfeng Capital and TF Capital — even as the company is getting more entrenched in the US with its CAR-T and other cell therapy work.

Shareholders are receiving $19.75 per share $CBMG, which translates to a premium of 31.4% over the 30 trading-day average price as of August 11. The stock, though, has dropped significantly since the consortium first put in its proposal in November. Compared to then, the acquisition price marks only a 11.8% increase.