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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Time for round 2: Il­lu­mi­na-backed VC snags $325M for its next fund

Illumina Ventures closed off its second investment fund with a total commitment of $325 million, offering fresh fuel to back a slate of startups that have already included a smorgasbord of companies, covering everything from diagnostics to biotech drug development and genomics.

Fund II brings the total investment under Illumina Ventures’ oversight to $560 million, which has been focused on early-stage companies. And it has a transatlantic portfolio that includes SQZ, Twist and Encoded Therapeutics.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Raju Mohan, Ventyx Biosciences CEO

Months af­ter a mam­moth raise, Ven­tyx Bio­sciences dips back in­to ven­ture well

Several months after emerging from what CEO Raju Mohan called “quiet mode” with a mammoth $114 million raise, Ventyx Biosciences is now making its plans for the clinic loud and clear.

The California-based immune modulation player kicked the week off with a $51 million Series B, while also naming some key hires ahead of its big clinical push.

The CMO slot is going to Jörn Drappa, former CMO at Viela Bio before it was bought out by Horizon Therapeutics earlier this year. The AstraZeneca vet stayed on at Horizon for a while as executive VP of R&D before making the jump to Ventyx.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.