News brief­ing: Mer­ck’s Roger Perl­mut­ter buys his first sol­id tu­mor TriN­KET from Drag­on­fly; Vi­Gen­eron to ex­pand pro­duc­tion of eye gene ther­a­py

Roger Perl­mut­ter

A lit­tle more than 2 years af­ter Mer­ck’s Roger Perl­mut­ter signed off on a deal that would pay Drag­on­fly up to $695 mil­lion for each drug pro­gram it picked off for sol­id tu­mors, the phar­ma gi­ant is step­ping up with their first opt-in.

We don’t know ex­act­ly how much this deal costs Mer­ck in the up­front, or which im­munother­a­py they’re get­ting, but it’s a ma­jor step for­ward for Bill Haney’s Waltham, MA-based biotech, which built its TriN­KET tech­nol­o­gy plat­form with the help of Tyler Jacks, an MIT pro­fes­sor, HH­MI in­ves­ti­ga­tor and di­rec­tor of the David H. Koch In­sti­tute for In­te­gra­tive Can­cer Re­search as well as Berke­ley’s David Raulet, whose back­ground as an ex­pert in NK cells and tu­mor im­munol­o­gy helped spot­light some of the big ideas Drag­on­fly is pur­su­ing.

This lat­est pact marks the lat­est in a flur­ry of BD deals for the phar­ma gi­ant, just one last step be­fore Perl­mut­ter hangs it up as head of R&D and pass­es the reins to Dean Li. — John Car­roll

Gene ther­a­py play­er Vi­Gen­eron part­ners with CT­D­MO to boost pro­duc­tion of eye pro­gram

A lit­tle over a year since an­nounc­ing its Se­ries A, gene ther­a­py biotech Vi­Gen­eron has en­tered in­to a new deal.

The Ger­man com­pa­ny is part­ner­ing with WuXi Ad­vanced Ther­a­pies, a con­tract test­ing, de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion un­der WuXi AppTec based out of Philadel­phia, to ramp up pro­duc­tion of Vi­Gen­eron’s lead can­di­date VG901 for oph­thalmic dis­or­ders. VG901’s cur­rent tar­get is for re­tini­tis pig­men­tosa, al­so known as rod cone dy­s­tro­phy, a de­gen­er­a­tive eye dis­ease that caus­es se­vere vi­sion im­pair­ment as ear­ly as child­hood.

Man­u­fac­tur­ing for the can­di­date should be­gin be­fore the year is out, Vi­Gen­eron said in a state­ment. The com­pa­ny added that the pro­gram came out of its pro­pri­etary vgAAV vec­tor plat­form, which al­lows for bet­ter trans­duc­tion of reti­nal cells as well as a less in­va­sive treat­ment ad­min­is­tra­tion.

There is cur­rent­ly no cure for the dis­ease, though there are some meth­ods that can help man­age symp­toms like the use of low vi­sion aids and portable light­ing. Pa­tients of­ten ex­pe­ri­ence wors­en­ing pe­riph­er­al vi­sion and trou­ble see­ing at night. — Max Gel­man

Cas­din co-leads $13M in­fu­sion in­to am­bi­tious lentivi­ral vec­tor man­u­fac­tur­er

Lentivi­ral vec­tor man­u­fac­tur­er iVex­Sol has raised $13 mil­lion in Se­ries A fi­nanc­ing, bring­ing the to­tal haul to $15.2 mil­lion from Cas­din Cap­i­tal and Bi­o­Life So­lu­tions and a third undis­closed lead in­vestor.

Found­ed on the promise to change the way this crit­i­cal raw ma­te­r­i­al is made us­ing next-gen­er­a­tion man­u­fac­tur­ing tech, the com­pa­ny said it can pro­duce LVVs “at sig­nif­i­cant­ly greater quan­ti­ties than tra­di­tion­al tran­sient trans­fec­tion process­es.” The com­pa­ny’s name is short for “in­tel­li­gent vec­tor so­lu­tions.”

Much like ade­no-as­so­ci­at­ed vi­ral vec­tors, or AAV, these de­liv­ery ve­hi­cles are cru­cial for cell and gene ther­a­pies such as CAR-T, iVex­Sol added, and their short­age means de­vel­op­ers of­ten have to wait 12 to 18 months for pro­duc­tion slots.

De­tails on ex­act­ly how it plans to “rev­o­lu­tion­ize” the space are scant, but CEO Rod Ri­et­ze and CSO Mike Greene both bring tech­ni­cal ex­pe­ri­ence from shops like No­var­tis and Pfiz­er.

Its new fund­ing will help es­tab­lish a fa­cil­i­ty in Lex­ing­ton, MA hous­ing sta­ble LVV pro­duc­er cell line mas­ter banks and com­mer­cial-grade LVV. — Am­ber Tong

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.