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.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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FDA ap­proves the third NMOSD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

There were no FDA approved treatments for neuromyelitis optica spectrum disorder at the start of 2019. Now, as of Friday, there are three.

The latest entrant to the market is the Roche/Genentech drug satralizumab after US regulators gave it the thumbs up late Friday. An IL-6 inhibitor, the drug joins Alexion’s Soliris and AstraZeneca spinout Viela Bio’s Uplizna. The annual cost of satralizumab — which will hit the market as Enspryng — will be $190,000 for 13 doses, a Genentech spokesperson said, though the first year of treatment requires 15 doses and cost about $220,000.

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Charlie Silver (Mission Bio)

'We want to be every­where.' Mis­sion Bio rais­es $70M be­hind re­sis­tance-hunt­ing se­quenc­ing plat­form

Charlie Silver wants to look really, really closely at a lot of your cells. And he just got a lot of money to do so.

Silver’s startup, Mission Bio, raised $70 million in a Series C round Thursday led by Novo Holdings. The money, which brings Mission Bio to $120 million raised since its 2012 founding, will be used to advance the single-cell sequencing platform they built to detect early response or resistance to new cancer therapies.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 14. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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