Ed­i­tas and Blue­Rock join forces — and plat­form tech­nolo­gies — on a new wave of en­gi­neered cell ther­a­pies

Two promi­nent Boston-based biotechs are ty­ing their plat­form tech­nolo­gies to­geth­er to see how they can give each oth­er a boost to their re­spec­tive pipelines.

Emile Nuwaysir

In a deal an­nounce­ment shorn of any men­tion of cash, the gene edit­ing pi­o­neers at Ed­i­tas have agreed to share their CRISPR plat­form with Blue­Rock, a well fund­ed stem cell play­er — which launched with a $225 mil­lion round — look­ing to play a lead­ing role in the sec­ond wave of drug de­vel­op­ment go­ing on now in the re­gen­er­a­tive med­i­cine field.

Ed­i­tas’ pri­ma­ry in­ter­est will be pur­su­ing new, en­gi­neered cell med­i­cines for sol­id tu­mors and blood can­cers while Blue­Rock wants to ap­ply CRISPR tech for neu­rol­o­gy, car­di­ol­o­gy and im­munol­o­gy.

Cindy Collins

“Blue­Rock and Ed­i­tas share a com­mon be­lief in the dis­rup­tive po­ten­tial of uti­liz­ing an en­gi­neered cell as a ther­a­peu­tic,” not­ed Blue­Rock CEO Emile Nuwaysir. And Cindy Collins, the in­ter­im chief of Ed­i­tas in the wake of Ka­trine Bosley’s re­cent sud­den de­par­ture, men­tioned the val­ue of cre­at­ing off-the-shelf al­lo­gene­ic meds.

They al­so men­tion de­vel­op­ment, reg­u­la­to­ry, com­mer­cial mile­stones and roy­al­ties on any­thing they work on, pro­vid­ed it gets past reg­u­la­tors, of course. But we don’t have the par­tic­u­lars.

Im­age: Shut­ter­stock

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)

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

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.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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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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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.

Credit: Galaxy Life Sciences

Galaxy Life Sci­ences lands $50 mil­lion deal to build in cen­tral Mass­a­chu­setts bio­man­u­fac­tur­ing park

Webster, MA-based real estate developer Galaxy Life Sciences struck a roughly $50 million deal to build in a biomanufacturing park in Worcester, an up-and-coming biotech hotspot about an hour west of Boston.

Galaxy paid $1.9 million for a 6-acre plot, on which it intends to construct a $50 million building grossing 95,000 to 180,000 square feet. The space will be designed to accommodate research and development, or manufacturing, and could employ 125 to 150 workers, according to the Worcester Telegram & Gazette. Construction is expected to begin this spring and wrap up in about a year.

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.

No­vo gets PhI­II he­mo­phil­ia tri­als for a Roche ri­val back on track af­ter com­plet­ing work-around on blood clot threat

After abruptly shutting down three hemophilia studies back in March due to serious safety issues, Novo Nordisk is getting things going again.

The Danish pharma gave the go-ahead to resume Phase III trials for its concizumab candidate, which are investigating subcutaneous prophylaxis treatment in hemophilia A and B patients regardless of inhibitor status. Novo Nordisk had halted the studies after three patients experienced non-fatal blood clots.

Argentine President Alberto Fernandez at an Aug. 12, 2020 press conference (Juan Mabromata/Pool via AP)

Covid-19 roundup: As­traZeneca teams with Ar­genti­na, Mex­i­co to sup­ply Latin Amer­i­ca; Brazil, Philip­pines in talks with Rus­sia

The global network building AstraZeneca and Oxford’s Covid-19 vaccine grew again this week.

Argentine President Alberto Fernandez said Wednesday after a meeting with company executives that Argentina and Mexico would produce and supply AstraZeneca’s adenovirus vector vaccine for all of Latin America outside Brazil, according to Reuters. The deal, financed in part by Mexican billionaire Carlos Slim, will involve AstraZeneca transferring its technology to the Spanish-Argentinian biotech mAbxience, who will then produce 150 million doses of the vaccine for delivery in the first half of 2021.

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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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Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

UP­DAT­ED: Bris­tol My­ers Squibb com­mits $300 mil­lion to com­bat racial dis­par­i­ties, but de­clines to re­lease own de­mo­graph­ic da­ta

After the police killing of George Floyd, a flurry of pharma and biotech companies, executives and investors jumped out to make statements, either expressing support for Black Lives Matter and the protests or condemning systemic racism.

Now, a Big Pharma company is publicly putting some teeth behind those statements. This morning, Bristol Myers Squibb announced they would spend $300 million on a broad effort to reduce racial health disparities, and diversify both their clinical trials and their own executive team and workforce.