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)

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.