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.

In a sec­ond big set­back for Covid-19 an­ti­body treat­ment hopes, Re­gen­eron halts en­roll­ment for more se­vere pa­tients

Regeneron has just delivered more bad news for the hope that neutralizing antibodies could be used to treat patients with more severe forms of Covid-19.

The New York biotech said today that an independent monitoring committee recommended halting enrollment of patients who need high-flow oxygen or mechanical ventilation in one of the trials on their antibody cocktail, after finding “a potential safety signal” and “an unfavorable risk/benefit profile.” The news comes a week after the NIH scrapped a trial of Eli Lilly’s Covid-19 antibody after finding it was having little effect on an initial cohort of hospitalized patients.

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George Golumbeski (L) and Faheem Hasnain

George Golumbes­ki and Fa­heem Has­nain team up with Ver­tex Ven­tures HC in man­ag­ing $320M of biotech cash

Two longtime biotech veterans are joining a multibillion dollar VC firm in order to help steer its latest fund.

George Golumbeski and Faheem Hasnain have signed on to Vertex Ventures HC as executive advisors, the company announced Thursday, and will assist with their depth of experience in managing $320 million of capital. Both have had previous working relationships with managing partners Carolyn Ng and Lori Hu, which evolved “organically” to get to this point, Ng said.

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Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Noubar Afeyan, Flagship founder and CEO (Victor Boyko/Getty Images)

UP­DAT­ED: Flag­ship launch­es Sen­da Bio­sciences with $88M in back­ing, look­ing to pi­o­neer the field of 'In­ter­sys­tems Bi­ol­o­gy'

Flagship Pioneering has a fresh company out this week, one that aims to lay the groundwork for a whole new discipline.

Senda Biosciences launched Wednesday with $88 million in Flagship cash. The goal? Gain insights into the molecular connections between people and coevolved nonhuman species like plants and bacteria, paving the way for “Intersystems Biology.”

Guillaume Pfefer has been tapped to run the show, a 25-year biotech veteran who comes from GSK after leading the development of the company’s shingles vaccine.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Eli Lilly CEO David Ricks (Evan Vucci/AP Images)

A p-val­ue of 0.38? NE­JM re­sults raise new ques­tions for Eli Lil­ly's vaunt­ed Covid an­ti­body

Generally, a p-value of 0.38 means your drug failed and by a fair margin. Depending on the company, the compound and the trial, it might mean the end of the program. It could trigger layoffs.

For Eli Lilly, though, it was part of the key endpoint on a trial that landed them a $1.2 billion deal with the US government to supply up to nearly 1 million Covid-19 antibodies.

So what does one make of that? Was the endpoint not so important, as Lilly maintains? Or did the US government promise a princely sum for a pedestrian drug?

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As­traZeneca sells off heart fail­ure and hy­per­ten­sion drugs to Chep­lapharm for $400M

Out with the old and in with the new: AstraZeneca is selling off two heart failure and hypertension drugs to Germany-based Cheplapharm, bagging $400 million and making way for development in other areas.

Cheplapharm paid $200 million for the European rights to Atacand (candesartan cilexetil) and Atacand Plus (candesartan cilexetil and hydrochlorothiazide) back in 2018. They’re now doubling that amount for commercial control in more than 70 countries.

News brief­ing: Ax­o­vant faces months of de­lay on lead Parkin­son's gene ther­a­py; Chi­nese CAR-T biotech nabs $100M

One of Axovant’s top gene therapy prospects for its second act is hitting a roadblock that could push its clinical timelines back by almost a year.

In an update, the biotech said it was informed about delays in CMC data and third-part fill-finish issues around mid-October by its manufacturing partner, Oxford Biomedica. Axovant has been developing a suspension-based process for the Parkinson’s drug; with that taking longer than expected, it now believes “it is unlikely that its planned randomized, sham-controlled trial of AXO-Lenti-PD will enroll patients by the end of calendar year 2021.”

Ugur Sahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

Covid-19 roundup: Flush with $486M con­tract, As­traZeneca signs Lon­za up to man­u­fac­ture an­ti­bod­ies; BioN­Tech's Ugur Sahin ex­pects vac­cine da­ta 'in a fort­night'

Days after scoring a $486 million BARDA contract to develop and manufacture its long-acting antibody combo for Covid-19, AstraZeneca has tapped Lonza to produce the drug substance at its mid-scale facility in Portsmouth, NH.

The drug, dubbed AZD7442, puts together two antibodies, first discovered by scientists at Vanderbilt University Medical Center, derived from convalescent patients who recovered from a SARS-CoV-2 infection. AstraZeneca licensed them in June and has since further engineered them with half-life extension and reduced Fc receptor binding.