Sil­i­con Val­ley celebs chip in­to $250M round for age-fight­ing start­up Celu­lar­i­ty. Pla­cen­ta-based CAR-Ts on the hori­zon?

A star-stud­ded Cel­gene spin­out is step­ping out to­day with $250 mil­lion in fresh cash to de­vel­op its quick­ly ma­tur­ing stem cell plat­form to treat can­cer, au­toim­mune dis­or­ders, and ul­ti­mate­ly to de­lay the ag­ing process.

Robert Hariri

The com­pa­ny, called Celu­lar­i­ty, is a New Jer­sey-based start­up co-found­ed by X-Prize founder Pe­ter Dia­man­dis and ex-Cel­gene ex­ec­u­tive Bob Hariri. You might al­so know these guys as the co-founders of Hu­man Longevi­ty, an­oth­er age-fight­ing start­up that scored a sim­i­lar­ly huge round of start­up cash back in 2016.

Celu­lar­i­ty is chock full of big names in both biotech and tech, with a board that in­cludes for­mer Ap­ple CEO John Scul­ley, GV (for­mer­ly Google Ven­tures) founder and Sec­tion 32 cre­ator Bill Maris, and ex-FDA com­mis­sion­er An­drew Von Es­chen­bach.

Pe­ter Dia­man­dis

Al­though brand new, the com­pa­ny is not com­plete­ly green. The com­pa­ny’s tech has been built up at Cel­gene over the past decade. The phar­ma gi­ant went through a se­ries of ac­qui­si­tions years ago when pla­cen­tal cells were be­ing hyped as a so­cial­ly ac­cept­able al­ter­na­tive to em­bry­on­ic stem cells. All these years lat­er, that tech was spun out in­to Celu­lar­i­ty, a com­pa­ny that launched last sum­mer with 200 is­sued and pend­ing patents, pre­clin­i­cal and clin­i­cal as­sets, and com­mer­cial prod­ucts ac­quired from Cel­gene, Sor­ren­to, Unit­ed Ther­a­peu­tics, and Hu­man Longevi­ty.

“Celu­lar­i­ty was formed as a new biotech­nol­o­gy mod­el de­signed to ap­ply the nec­es­sary ex­per­tise to har­ness our pla­cen­ta dis­cov­ery plat­form across a range of un­met med­ical needs,” Hariri said in a state­ment at the time.

One ap­pli­ca­tion for the com­pa­ny’s busi­ness has biotech par­tic­u­lar­ly in­trigued. The com­pa­ny says it plans to build CAR-T ther­a­pies us­ing pla­cen­tal cells, not a pa­tient’s own T-cells, which, in the­o­ry, will cre­ate stan­dard­ized prod­uct that won’t cause the pa­tient’s im­mune sys­tem to flare in protest. Celu­lar­i­ty will ask the FDA to start tri­als on a CAR-T tar­get­ing a pro­tein called CD38, and says it’s li­censed 50 oth­er po­ten­tial CAR-T con­structs from Sor­ren­to.

The com­pa­ny is al­so work­ing on treat­ments for wound heal­ing and rheuma­toid arthri­tis, as well as cell ther­a­py can­di­dates.

“The ob­jec­tive is to make 100 years of age an ex­treme­ly achiev­able goal for peo­ple, but to al­low their bi­o­log­ic func­tion­al­i­ty to work like it did when they were decades younger,” Hariri told CNET.

Weidong Yin, Getty Images (Peter Parks)

Sino­vac posts pos­i­tive PhI/II da­ta for their Covid-19 vac­cine as re­searchers rush in­to a piv­otal test

Beijing-based Sinovac has posted a positive preliminary snapshot of human data from the Phase I/II study of their vaccine for coronavirus, showing that the jab was able to safely spur protective antibodies in more than 90% of the volunteers involved.

The biotech reported Saturday that they had recruited 743 patients for the two-step trial, with 143 in Phase I and the rest in Phase II.

“The neutralizing antibody seroconversion rate is above 90%,” the company states, “which concludes the vaccine candidate can induce positive immune response.” That’s about all you’re getting at this stage of the process, though, with little hard data in their statement to decipher.

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Stéphane Bancel, Moderna CEO (AP Images)

Mod­er­na floors it in­to PhI­II with their Covid-19 vac­cine, plan­ning quick start with a thumbs-up from FDA on tri­al de­sign, dosage

Right now, the overarching strategy behind developing a Covid-19 vaccine calls for getting the work done fast. And Moderna’s team is flooring their program into a Phase III pivotal in a matter of weeks after selecting the dose needed.

The messenger RNA biotech reported this morning that it is advancing its coronavirus vaccine — mRNA-1273 — into a pivotal Phase III with 30,000 participants starting in July, just weeks away. With feedback from the FDA, Moderna has settled on the trial design and a 100 μg dose, and they have the manufacturing capacity lined up to produce anywhere from 500 million to 1 billion doses a year starting in 2021. Working in collaboration with the NIH, Moderna has also won considerable backing from BARDA.

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Mark Kotter, University of Cambridge

Sure, Bit Bio got some sig­nif­i­cant cash for its cell cod­ing work. But it’s the in­sid­ers who are back­ing them that will gar­ner the at­ten­tion

Mark Kotter’s synthetic biology team at Bit Bio has already won lots of local recognition in the UK for its tech for precision reprogramming of stem cells at an industrial scale. Now they have a jolt of cash from some marquee US investors to fuel the work and drive some added global panache for the biotech’s profile.

The money — $41.5 million — isn’t likely to stir much attention these days as billions in cash continue to course through the industry. These investor names, though, as well as their interest in cell therapy 2.0, should create a tingle of excitement.

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An­a­lysts cheer as Ab­b­Vie pays $750M cash to al­ly it­self with Gen­mab on a pipeline of can­cer drugs, with bil­lions more on the ta­ble

You can count the R&D execs at AbbVie among the believers in Genmab’s bispecific platform tech.

Moving beyond the Allergan buyout, AbbVie refocused on its cancer drug pipeline, shelling out $750 million in cash and promising up to $3.15 billion more in milestones — 60% for development and regulatory goals — to ally itself on a slate of 7 development and discovery programs.

At the front of the queue is the early-stage drug epcoritamab, a CD3xCD20 bispecific from its DuoBody collection. There’s also DuoHexaBody-CD37 and DuoBody-CD3x5T4. And then AbbVie gets to pick and choose from among the discovery work at Genmab for 4 more, with AbbVie adding in its own contributions in the pairing up to come.

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Mod­er­na bur­nish­es its PhI­II-ready Covid-19 vac­cine with promis­ing mouse da­ta — which sug­gest one dose might be enough af­ter all

Moderna and the NIH didn’t wait for animal data to begin testing its mRNA vaccine candidate in patients. But on the same day they unveiled plans for an ultra-fast Phase III in July, scientists also released mouse data that they say back up and inform the pivotal study.

In a preprint, the combined team from Anthony Fauci-led NIAID and Moderna’s infectious disease unit reported their vaccine generated “potent neutralizing activity” and appeared to protect mice from a viral infection up to 13 weeks post-injection. Perhaps more importantly, no safety signals emerged when they challenged the mice with the coronavirus.

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Covid-19 roundup: Chi­na's Sino­vac goes to Brazil for PhI­II; As­traZeneca signs Emer­gent on for $87M man­u­fac­tur­ing deal

Sinovac, the first Chinese biotech to publish animal data on a Covid-19 vaccine, is teaming up with a Brazilian partner to test its candidate in the South American country.

Instituto Butantan is still awaiting clearance from local authorities to kick off the Phase III trial, which will enroll 9,000 people in July. The company will get a license for the vaccine in Brazil should it prove effective.

As new infections in China become a rare occurrence, scientists have run into the bizarre problem of not having enough exposure to really know whether the inoculations are protecting their volunteers.

David Altshuler at Endpoints event in 2018 (Rob Tannenbaum for Endpoints News)

Ver­tex and CRISPR spot­light an­oth­er im­por­tant gene edit­ing ad­vance in a march to a hoped-for cure

Vertex and CRISPR Therapeutics have successfully navigated another stretch of the maiden clinical journey of the gene editing therapy CTX001 in a tiny group of patients suffering from beta thalassemia and sickle cell disease. And the researchers involved say they have good reason to believe that they are still on the right track to proving they are advancing a potentially curative approach with a shot at best-in-class status.

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ARCH-backed Au­to­bahn launch­es with $76M to re­build myelin and re­verse MS

For decades, drugs for multiple sclerosis — and there have been many — have been almost exclusively band-aids: inhibitors designed to halt the damage before it got worse, which it inevitably and irreparably would.

But a couple years ago, Keith Lenden, a serial biotech entrepreneur and a newly-minted partner at ARCH Ventures, drove up to Oregon Health & Science University, where over a series of hour-long conversations, professor Tom Scanlan sketched out a new potential plan of attack.

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It's all about the heart: Di­a­betes ma­jor No­vo Nordisk bets $725M up­front to buy car­dio-fo­cused As­traZeneca spin­off

Novo Nordisk’s itch to expand its reach beyond its mainstay diabetes business has manifested in the company testing some of its existing treatments for use in co-morbidities such as obesity, NASH and heart disease. Now, the Danish drugmaker is forking over $725 million in cash upfront to swallow an AstraZeneca spinout focused on the cardio field.

Created in 2015, the company Corvidia was co-founded by Michael Davidson, the former chief medical officer of New Jersey-based Omthera (a company sold to AstraZeneca for $443 million back in 2013) and Sofinnova Partners, the European life sciences venture capital firm that also served as the lead investor in Omthera.

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