Google helps boost Grit­stone’s neoanti­gen R&D gam­ble to $195M as re­searchers prep for first hu­man study

Grit­stone On­col­o­gy launched one of the most promi­nent neoanti­gen R&D ef­forts in the in­dus­try with a $102 mil­lion mega-round two years ago. And now the biotech is lin­ing up its first big clin­i­cal for­ay — while lay­ing the foun­da­tion for an even­tu­al mar­ket launch — with an­oth­er mega-round that weighs in at $92.7 mil­lion.

This biotech is a prime ex­am­ple of the ven­ture com­mu­ni­ty’s will­ing­ness to go deep and long in an at­tempt to de­liv­er a lead­ing com­pa­ny in the hunt for new tech­nolo­gies to fight life-threat­en­ing dis­eases. And part of that gam­ble in­cludes con­struct­ing new man­u­fac­tur­ing fa­cil­i­ties that can sup­port the de­vel­op­ment of per­son­al­ized ther­a­pies — a blue­print that Grit­stone is com­mit­ted to.

An­drew Allen, Grit­stone

Lil­ly Asia Ven­tures took the lead on the round, with par­tic­i­pa­tion from GV (for­mer­ly Google Ven­tures), Bei­jing-based Trini­tas Cap­i­tal and Alexan­dria Ven­ture In­vest­ments, all new in­vestors and an ex­am­ple of the grow­ing amount of Chi­nese in­vest­ment cap­i­tal mak­ing its way in­to US biotechs. All ex­ist­ing in­vestors are al­so all par­tic­i­pat­ing in the round, in­clud­ing Ver­sant Ven­tures, The Col­umn Group, Clarus Funds and Fra­zier Health­care Part­ners.

Some of their new mon­ey will go to com­plet­ing a 43,000-square-foot man­u­fac­tur­ing fa­cil­i­ty in Pleasan­ton, CA.

Biotech goals don’t get much more am­bi­tious than what you’ll see at Grit­stone. Re­searchers are build­ing a plat­form tech aimed at iden­ti­fy­ing the rare mu­ta­tions that can be trans­lat­ed in­to per­son­al­ized neoanti­gen ther­a­pies for a slate of can­cers. And the biotech is prepar­ing to take its first shot at non-small cell lung can­cer with a tri­al set to launch in the mid­dle of next year.

You can find more than 300 mu­ta­tions in a pa­tient’s ex­ome that can be rel­e­vant to the unique neoanti­gen pro­fil­ing process for lung can­cer, Grit­stone CEO An­drew Allen tells me. But on­ly 1% — or three of them — will ac­tu­al­ly have ther­a­peu­tic val­ue. Find­ing that nee­dle in the prover­bial haystack re­quires the 65 staffers at Grit­stone to do their own se­quenc­ing, while de­vel­op­ing their own in-house deep learn­ing tech­nol­o­gy that can be ef­fec­tive in spot­ting the right mu­ta­tions.

This new round gets Grit­stone in­to the clin­ic, with proof-of-con­cept da­ta sched­uled to ar­rive in 2019 and the ini­tial man­u­fac­tur­ing fa­cil­i­ties they’ll need for the weeks-long ap­proach re­quired to go from biop­sy to se­quenc­ing and man­u­fac­tur­ing and then back to the pa­tient in an in­tra­mus­cu­lar in­jec­tion ther­a­py.

Allen is acute­ly aware of the va­ri­ety of ef­forts un­der­way to get out in front and de­liv­er the first neoanti­gen com­mer­cial pro­gram. He says there are two key mea­sures that will dic­tate which com­pa­ny is first.

First up: Iden­ti­fy­ing the right neoanti­gens for the treat­ment. Num­ber two: Learn­ing how to de­liv­er the anti­gens in a way that dri­ves the most ef­fec­tive as­sault of CD8-pos­i­tive T cells on can­cer cells. That weaponiza­tion tech led Gri­s­tone to fo­cus on vi­ral vec­tors in a “high­ly ad­ju­vant­ed” ap­proach to ther­a­py.

There are some sim­i­lar­i­ties be­tween this nascent field and CAR-T, the new per­son­al­ized can­cer ther­a­py that has just seen the first big OK. But Allen tells me there are some im­por­tant dis­tinc­tions.

One of the biggest, he says, is that Grit­stone wants its ther­a­pies de­liv­ered in com­mu­ni­ty cen­ters where most of the ac­tu­al treat­ment in the US is done — rather than the aca­d­e­m­ic cen­ters and hand­ful of qual­i­fied lo­ca­tions where CAR-T will be ad­min­is­tered.

That all de­pends on a new tech that has to be built in­to a com­mer­cial mod­el from the ground up. What’s that go­ing to cost?

“We haven’t worked out the fi­nal num­ber,” Allen tells me. A lot will de­pend on the mag­ni­tude of clin­i­cal ef­fect. “What we do know is that to do this se­ri­ous­ly is a ma­jor un­der­tak­ing.”

Cer­tain­ly an IPO is like­ly, when the time is ripe and there’s some­thing tan­gi­ble for gen­er­al­ists to look at. Part­ner­ships are a dis­tinct pos­si­bil­i­ty, which Allen says will prob­a­bly be built around “shared” anti­gens, where ther­a­pies can be de­vel­oped for spe­cif­ic buck­ets of pa­tients rather than on a one-on-one ba­sis.

In the mean­time, the ven­ture part­ners ap­pear ready to go all the way with this one.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.