News brief­ing: Five Prime fi­nal­izes PhI­II plans for gas­tric can­cer; AI di­ag­nos­tics-fo­cused Paige ex­pands staff

Five Prime Ther­a­peu­tics has fi­nal­ized a plan to take their come­back gas­tric can­cer drug in­to late-stage stud­ies.

The South San Fran­cis­co-based biotech re­leased full Phase II da­ta for be­mar­ituzum­ab on Fri­day, which Five Prime said in No­vem­ber met all of its pre-spec­i­fied ef­fi­ca­cy end­points in a topline read­out. Now, the com­pa­ny is an­nounc­ing it plans to launch a Phase III tri­al for the pro­gram in 2021. Fol­low­ing No­vem­ber’s read­out, the fu­ture of be­mar­ituzum­ab had not yet been fi­nal­ized.

Five Prime pre­sent­ed the full da­ta slate Fri­day at the 2021 AS­CO Gas­troin­testi­nal Can­cers Vir­tu­al Sym­po­sium, re­it­er­at­ing the topline re­sults and adding some col­or with sub­group da­ta.

Tom Civik

For the da­ta, Five Prime set their sights on p-val­ues for a 2-sided al­pha of less than 0.2, rather than the typ­i­cal 0.05. Out­comes im­proved in pro­gres­sion-free sur­vival from 7.4 months to 9.5 months, hit­ting a p-val­ue of 0.073, while over­all re­sponse rate im­proved by 13.1%, good for a p-val­ue of 0.106.

But in over­all sur­vival, which CEO Tom Civik told in­vestors last No­vem­ber would like­ly be the pri­ma­ry for a Phase III tri­al, Five Prime saw a me­di­an of 12.9 months in the con­trol arm and did not reach a fig­ure in the treat­ment arm. That hit a p-val­ue of 0.027.

The news thrilled in­vestors, with the com­pa­ny’s stock price near­ly qua­dru­pling with­in an hour of No­vem­ber’s an­nounce­ment. Shares reached an in­crease as high as about 400%. — Max Gel­man

AI di­ag­nos­tics-fo­cused Paige ex­pands staff af­ter $100M raise

The AI dig­i­tal di­ag­nos­tics play Paige is hir­ing 70 more staffers to work on its com­mer­cial roll­out af­ter rais­ing $100 mil­lion from a group of in­vestors led by J&J.

Cas­din Cap­i­tal and John­son & John­son In­no­va­tion – JJDC led the round, along with ex­ist­ing in­vestors and some un­named back­ers as well.

Eli Cas­din

Paige has been work­ing on the de­vel­op­ment of AI-based clin­i­cal ap­pli­ca­tions, bio­mark­ers and di­ag­nos­tics.

“Bend­ing the mor­tal­i­ty curve on can­cer is a hum­bling and crit­i­cal goal re­quir­ing big da­ta, big tech­nol­o­gy and big tal­ent,” notes Eli Cas­din in a state­ment. “Paige com­bines all three: Ro­bust AI ca­pa­bil­i­ties, ac­cess to mil­lions of dig­i­tal pathol­o­gy im­ages linked to the key clin­i­cal da­ta modal­i­ties of imag­ing, ge­nom­ic, and clin­i­cal/EMR da­ta, and a grow­ing team pur­pose built to de­liv­er. This is a unique op­por­tu­ni­ty to trans­form da­ta in­to a next gen­er­a­tion of can­cer di­ag­nos­tics and ther­a­peu­tics, with clear ap­pli­ca­tion be­yond can­cer, and we are ex­cit­ed to be joined by JJDC to fu­el the com­pa­ny to de­liv­er on this op­por­tu­ni­ty.”

— John Car­roll

Ar­cutis be­gins two Phase III stud­ies for atopic der­mati­tis cream

Ar­cutis has com­menced Phase III tri­als for its atopic der­mati­tis pro­gram.

The com­pa­ny an­nounced Fri­day that its rof­lu­mi­last cream has be­gun un­der­go­ing piv­otal stud­ies with about 650 pa­tients in each tri­al. Both stud­ies are iden­ti­cal, en­rolling mild to mod­er­ate AD pa­tients old­er than 6 years who will ap­ply the cream or place­bo once a day for four weeks.

Ar­cutis plans to ran­dom­ize the pa­tients to the drug and place­bo arms 2 to 1, look­ing to record scores of ‘clear’ or ‘al­most clear’ plus a 2-grade im­prove­ment from base­line at four weeks in an AD eval­u­a­tion con­duct­ed by in­ves­ti­ga­tors. The com­pa­ny al­so plans to launch a third study in chil­dren aged 2 to 5, with the tri­al com­menc­ing “short­ly.”

Rof­lu­mi­last cream is a dif­fer­ent for­mu­la­tion of the PDE4 in­hibitor, which has been ap­proved as an oral treat­ment for COPD since 2011. Ar­cutis’ can­di­date con­tains 0.15% rof­lu­mi­last. — Max Gel­man

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.

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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: 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.

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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.

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Mesoblast gets a $110M life­line from Surg­Cen­ter De­vel­op­ment; uniQure still un­sure if gene ther­a­py spurred can­cer event

Mesoblast faced rough waters in 2020, but on Monday were thrown a financial lifeline.

The Australian stem cell therapy player has raised $110 million in a private placement, the company announced, offering 60 million shares to the US investor group SurgCenter Development. SurgCenter received the shares at a 6.5% discount from Mesoblast’s closing price on Feb. 25.

Mesoblast plans to use the funds to boost supply of its lead candidate remestemcel-L ahead of what they hope is a potential approval in pediatric GvHD when they return to the FDA, as well as advancing manufacturing and development of their rexlemestrocel-L platform for chronic heart failure and chronic low back pain.

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.

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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.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.