Suck­ing up tal­ent out of No­var­tis, a boom­ing Ru­bius adds an­oth­er $100 mil­lion mega-round to the kit­ty

Just 8 months af­ter putting the fin­ish­ing touch­es to a $120 mil­lion round, Flag­ship start­up Ru­bius Ther­a­peu­tics is back at the mon­ey well, draw­ing up an­oth­er big mega-round of $100 mil­lion.

Tor­ben Straight Nis­sen

This time, with more than $220 mil­lion to the good since jump­ing off the start­ing line, Ru­bius de­scribes the raise as a “crossover round.” So does that mean that there’s an S-1 un­der con­struc­tion?

Not ex­act­ly.

“We’re con­sid­er­ing all op­tions,” says CEO Tor­ben Straight Nis­sen. As for an IPO, that’s one of sev­er­al routes that could be open to the com­pa­ny — when the time is right.

Un­usu­al­ly, the biotech is not spelling out where the cash is com­ing from. All that the CEO is will­ing to say is that the syn­di­cate in­cludes “some of the largest mu­tu­al funds…as well as oth­er ma­jor in­vestors.”

A few years ago it would have been a vir­tu­al mis­sion im­pos­si­ble to gath­er more than $200 mil­lion for a biotech that has yet to file its first IND. But Flag­ship chief Noubar Afeyan has been one of the lead­ing pro­po­nents of a move to find new plat­form com­pa­nies with big po­ten­tial for some game-chang­ing tech­nol­o­gy and then com­ing up with the big mon­ey need­ed to build a full pipeline of ther­a­pies, rather than one or two pi­lot projects to demon­strate their po­ten­tial.

Noubar Afeyan

It’s a high risk, high re­ward strat­e­gy that has been pur­sued ag­gres­sive­ly by Mod­er­na, an­oth­er Flag­ship com­pa­ny which just added $500 mil­lion on a $7 bil­lion val­u­a­tion — well ahead of piv­otal da­ta.

What­ev­er lim­it there may be to in­vestor ap­petite for biotech risk, we aren’t see­ing it yet. In the past 72 hours we’ve tracked more than $650 mil­lion in new in­vest­ments in the field, with the mon­ey scat­tered in Cam­bridge/Boston, the Bay Area, Mary­land and New York. The $250 mil­lion raised for a new As­traZeneca spin­out came from three new Chi­nese in­vestors, who are burst­ing on the scene with more cash for qual­i­fied syn­di­cates. And this is the sec­ond $100 mil­lion raise this week.

The R&D plan at Ru­bius is to push ahead with some lead en­zyme re­place­ment ther­a­pies be­ing spawned on a plat­form that seeks to de­vel­op a brand new class of cell ther­a­pies.

The big idea at Ru­bius is that re­searchers can take red blood cells — de­signed by na­ture to trans­port oxy­gen — hi­jack them through ge­net­ic en­gi­neer­ing tech and get them to car­ry pro­teins need­ed to fight var­i­ous dis­eases. It’s an off-the-shelf ap­proach, rather than one per­son­al­ized for each pa­tient.

De­vel­op­ing a new class of med­i­cine, though, calls ear­ly on for some pricey man­u­fac­tur­ing ca­pac­i­ty. And af­ter es­tab­lish­ing a sup­ply line with CMOs, Ru­bius is do­ing some cal­cu­la­tions on how it should con­struct its own in-house process.

“Clear­ly,” says the CEO, “one of the ex­plo­rations is build or buy.” And they don’t have to stay too close to home in Cam­bridge, MA. Oth­er lo­ca­tions in or around Boston and the rest of Mass­a­chu­setts could serve.

The staff, mean­while, has al­ready grown to 67, which in­cludes adding a man­u­fac­tur­ing chief. Spencer Fisk jumped to Ru­bius just a few days ago, join­ing what seems to be a steady mi­gra­tion out of No­var­tis’ cell and gene ther­a­py op­er­a­tion. He was the glob­al head of Cell and Gene Tech­ni­cal De­vel­op­ment and Man­u­fac­tur­ing. Fisk took the place of Karen Walk­er, who left for Seat­tle Ge­net­ics last spring. Walk­er had, in turn, be­come one of three key man­agers in the cell unit at No­var­tis, which was thor­ough­ly re­or­ga­nized about two years ago, when Us­man “Oz” Azam left the helm to run a cell ther­a­py start­up.

It’s a small world in the cell ther­a­py field. Now Fisk is work­ing at a biotech where for­mer No­var­tis can­cer chief David Ep­stein is ex­ec­u­tive chair­man.

Burst­ing at the seams, Ru­bius is al­so now mov­ing in­to 45,000 square feet in new digs at 399 Bin­ney. By this sum­mer, he adds, the staff should be up to around 100 — no small af­fair.

Im­age: 399 Bin­ney Street (Alexan­dria Re­al Es­tate Eq­ui­ties)

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Abbie Celniker (L) and Rob Sims (Flare)

A Third Rock-backed play­er charts a new course against tran­scrip­tion fac­tors. Do 'switch sites' hold the mag­ic sauce?

Long known for their role in guiding gene expression but considered “undruggable,” DNA binding transcription factors have long been a Holy Grail for drug developers. Now, a new startup from Third Rock Ventures thinks it could have the juice to get after transcription factors once and for all — and it all started with a “flare” of inspiration from an article out of an Oxford lab.

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