Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Grit­stone On­col­o­gy has had a big week, and it’s on­ly Wednes­day.

On Tues­day, the biotech re­vealed plans to start clin­i­cal test­ing of an ex­per­i­men­tal Covid-19 vac­cine — in tan­dem with NI­AID — that can al­so tar­get oth­er coro­n­avirus­es, with the goal of pre­vent­ing fu­ture pan­demics should SARS-CoV-2 prove dif­fi­cult to cure with cur­rent vac­cines. Then, on Wednes­day morn­ing, Grit­stone li­censed lipid nanopar­ti­cle tech­nol­o­gy from Genevant Sci­ences to de­vel­op what it’s call­ing “self-am­pli­fy­ing RNA vac­cines” against Covid-19.

“As we con­tin­ue to see new strains of SARS-CoV-2 emerge, we iden­ti­fied an op­por­tu­ni­ty to ap­ply our key strengths to an in­no­v­a­tive COVID-19 vac­cine,” Grit­stone CEO An­drew Allen said in a state­ment. “Specif­i­cal­ly, ex­tend­ing the anti­genic con­tent of a COVID-19 vac­cine be­yond Spike alone may open up a route to clin­i­cal pro­tec­tion even if Spike mu­ta­tions re­duce an­ti­body bind­ing.”

Per the com­pa­ny’s in­vestor pre­sen­ta­tion, the Genevant deal will pro­vide the foun­da­tion for the sec­ond part of the com­pa­ny’s Covid-19 ap­proach, com­bin­ing RNA with ade­n­ovirus vac­cines. Grit­stone plans to give pa­tients one shot of each type of vac­cine se­quen­tial­ly, with the ade­n­ovirus shot first and the RNA-based shot sec­ond.

Should the Genevant pro­gram hit all of its mile­stones, Grit­stone would be on the hook for $192 mil­lion. Grit­stone is al­so pay­ing an undis­closed up­front pay­ment that ac­counts for part of that sum, and Genevant is el­i­gi­ble for roy­al­ties in the mid-sin­gle to mid-dou­ble dig­its.

Grit­stone was found­ed back in 2015 on the idea that tar­get­ing rare mu­ta­tions in can­cer can boost the ef­fi­ca­cy of check­point in­hibitors. The com­pa­ny has tak­en a neoanti­gen ap­proach to fight­ing can­cer, ze­ro­ing in on com­mon sol­id tu­mors like metasta­t­ic non-small cell lung can­cer and gas­troe­sophageal, blad­der and col­orec­tal can­cers since it sought its IPO in 2018.

But this week casts the spot­light on the biotech’s Covid-19 ef­forts, one that has al­ready proved fi­nan­cial­ly fruit­ful for in­vestors. Shares rock­et­ed up rough­ly 250% in the wake of Tues­day’s news, send­ing Grit­stone’s $GRTS stock price north of $20 for the first time since De­cem­ber 2018. As the mar­ket opened Wednes­day, the stock con­tin­ued its as­cent by shoot­ing up an­oth­er 50% and hit a new all-time high.

Wednes­day’s deal is an ex­ten­sion of Grit­stone’s col­lab­o­ra­tion with Genevant signed back in 2017, though it won’t pro­vide Grit­stone with ex­clu­sive ac­cess to the plat­form. The agree­ment was ex­pand­ed in Oc­to­ber as well to in­clude Genevant’s plat­form in de­vel­op­ment for a can­cer in­di­ca­tion, with Grit­stone pay­ing up to $71 mil­lion.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

David Chang, WuXi AppTec

A 'love sto­ry': WuXi AppTec wraps UK-based CRO in­to its cell and gene ther­a­py unit

When WuXi AppTec, one of China’s largest contract research organizations, started working with UK-based Oxgene about a year ago, it was “love at first sight,” CEO David Chang jokes.

Oxgene, a roughly decade-old CRO focused on scalable gene therapy tech, began licensing some of their plasmid work to WuXi just over a year ago. And when that pilot went well, WuXi expressed interest in investing, Oxgene CEO Ryan Cawood said.