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.

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

Christos Kyratsous (via LinkedIn)

He built a MERS treat­ment in 6 months and then the best Ebo­la drug. Now Chris­tos Kyrat­sous turns his sights on Covid-19

TARRYTOWN, NY — In 2015, as the Ebola epidemic raged through swaths of West Africa, Kristen Pascal’s roommates sat her down on their couch and staged an intervention.

“Are you sure this is what you want to be doing with your life?” she recalls them asking her.

Pascal, a research associate for Regeneron, had been coming home at 2 am and leaving at 6 am. At one point, she didn’t see her roommate for a week. For months, that was life in Christos Kyratsous’ lab as the pair led a company-wide race to develop the first drug that could effectively treat Ebola before the outbreak ended. For Pascal, that was worth it.

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Left to right, top to bottom: Carl Gordon, Adam Stone, Peter Moglia, David Schenkein, Robert Nelsen, Carol Gallagher; Srinivas Akkaraju, Ray Debbane, Jim Flynn, Peter Kolchinsky, Thilo Schroeder, Brad Bolzon

UP­DAT­ED: The top 100 bio­phar­ma ven­ture in­vestors at the mega­bil­lions deal ta­ble

The VC crowd took a step back last year, but nevertheless maintained a furious pace of new investments in therapeutic tech platforms and biotech startups. And the top 100 players completely dominated the megabillions game.

Just looking at the number of deals done by each of the top 100, OrbiMed came in at the top, with 20, followed by Alexandria (18), Perceptive (16) and the ubiquitous RA Capital at 16. It’s impossible to say exactly how much they invested in total — those numbers are only rarely provided — but it is clear from the numbers assembled by Chris Dokomajilar at DealForma who’s most likely to be found sitting at the table during the go-go days of biotech investing.

Dokomajilar tracked $14.06 billion in biotech venture investing last year, a dip from the frenzied pace of $16.02 billion in 2018 and more than $10 billion higher than he recorded for 2010, as the economy was recovering from a profound economic crisis.

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Rahul Ballal, Imara

As sick­le cell pa­tients find new op­tions, NEA-found­ed Imara pitch­es mid-stage al­ter­na­tive for $86M IPO

November 2019 proved to be a fruitful month for patients with blood disorders known as hemoglobinopathies. Within days, the FDA ushered two drugs for sickle cell disease and another for beta thalassemia to the market — livening up a barren field.

Imara, a relatively young plower, is riding on that enthusiasm as it shoots for an $86.25 million IPO.

Imara emerged from New Enterprise Associates’ orphan drug accelerator Cydan in 2016 as a single-product company. $77.3 million in private financing later IMR-687 remains the sole asset in its pipeline; the difference is the drug is now in Phase II for sickle cell disease, with topline data slated for later this year and two other mid-stage beta thalassemia studies lined up.

UP­DAT­ED: RA joins glob­al syn­di­cate to back a $98M round for CAN­bridge

A Beijing-based rare disease and oncology player has raised $98 million to help fund the expansion of its pipeline as well as a commercial portfolio.

CANbridge put out word Tuesday that the global private equity player General Atlantic joined forces with Chinese CRO Wuxi AppTec to lead the Series D, with both ready to chip in an extra $10 million each under the right conditions. The syndicate includes RA Capital Management, Hudson Bay Capital Management, YuanMing Prudence Fund and Tigermed.

Carol Robinson, Professor Dame Carol Robinson Research Group

UP­DAT­ED: Drug dis­cov­ery in HD: Ox­ford spin­of­f's mass spec­trom­e­try ap­proach scores fresh fund­ing

The technology used to detect explosives at airports — mass spectrometry — is being piloted as an engine for drug discovery.

Mass spectrometry is a tool designed to measure with profound accuracy the mass of a single molecule. Typically, mass spectrometers can be used to identify unknown compounds, to quantify known compounds, and to determine the structure and chemical properties of molecules.

Lars Fruergaard Jørgensen, chief executive officer of Novo Nordisk A/S, (via Getty Images)

The list of the 11 block­busters-to-be in line for a 2020 launch high­light agony and ec­sta­sy of drug R&D

For all the talk about unmet medical need and patients first and so on, the key criteria investors watch for any new drug in the pipelines is peak sales projection. Are you going to hit the blockbuster mark, at $1 billion-plus, or are you going to be an also-ran in the sales department?

Of course, analysts’ peak sales projections by themselves are of limited value in many cases. When the PCSK9 drugs started arriving 5 years ago, Repatha was billed as a $2.5 billion peak earner. They’re nowhere near that, with new competition threatening current levels. And if Biogen’s controversial Alzheimer’s drug aducanumab (submission planned but not on the list) is approved, per chance, will payers cover it?

Maybe not. And then those $10 billion in peak sales assumptions would go straight down the drain.

But, analysts are analysts, and peak sales projections have to be factored in when assessing the top experimental drugs up for a launch in the year ahead.

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UP­DAT­ED: Chi­na ap­proves flu drug be­ing tout­ed as a po­ten­tial coro­n­avirus treat­ment amid a rush of clin­i­cal stud­ies

One of the three drugs that China’s Ministry of Science and Technology has tapped as potential COVID-19 treatments to watch has notched its first Chinese OK — for the flu.

While there’s no proof yet that fapilavir, or favipiravir, is the cure that patients and physicians are yearning for, it stands out for a unique constellation of qualities. It’s been commercially available in Japan for several years (unlike Gilead’s experimental remdesivir) yet it’s new to China (unlike the malaria drug chloroquine phosphate). Perhaps more importantly, a domestic biotech — Zhejiang Hisun Pharma — owns the rights to manufacture and market the drug, preempting any concerns about patents.

FDA goes on high alert as coro­n­avirus rais­es threat to drug man­u­fac­tur­ing and clin­i­cal tri­als grind to a halt

The FDA isn’t quite sure just what the coronavirus outbreak in China will mean for the US pharma industry, but it has the potential to trigger a host of troublesome issues around the supply chain the country is directly plugged into.

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