Christine Bunt, Robert Langer. Verseau

Armed with Langer tech and $50M, Verseau hails new check­point drugs un­leash­ing macrophages against can­cer

The ris­ing pop­u­lar­i­ty of CD47 has pro­pelled the “don’t-eat-me” sig­nal to house­hold name sta­tus in the im­muno-on­col­o­gy world: By block­ing that pro­tein, the the­o­ry goes, one can stop can­cer cells from fool­ing macrophages. But just as PD-(L)1 mere­ly rep­re­sents the most fruit­ful of all check­points reg­u­lat­ing T cells, Verseau Ther­a­peu­tics is con­vinced that CD47 is one of many reg­u­la­tors one can mod­u­late to stir up or tame the im­mune sys­tem.

“Macrophages are in­ter­est­ing be­cause we were all ed­u­cat­ed prob­a­bly 20 years ago that they are the big eaters in the im­mune sys­tem, but they’re re­al­ly the or­ches­tra­tors of the im­mune sys­tem,” CEO Chris­tine Bunt said.

But the cells are al­so high­ly so­phis­ti­cat­ed and hard to work with, and pre­vi­ous ap­proach­es have fo­cused more on de­plet­ing than mo­bi­liz­ing them.

Dan An­der­son

So Bunt, a Big Phar­ma vet who’s then a part­ner at 20/20 Health­Care Part­ners, called Bob Langer at MIT hop­ing to find a way to work with non-T cell tar­get­ing im­munother­a­pies. The duo had worked to­geth­er to start Taris Med­ical — which was even­tu­al­ly sold to Al­ler­gan — and this time around she li­censed siR­NA de­liv­ery tech from Langer and Koch In­sti­tute in­ves­ti­ga­tor Dan An­der­son for a val­i­da­tion and dis­cov­ery plat­form. They al­so wooed Ig­or Feld­man and Ta­tiana Novo­brant­se­va, two sci­en­tists in­volved in cre­at­ing Jounce Ther­a­peu­tics.

Af­ter re­ceiv­ing its first in­jec­tion of cap­i­tal in 2017, Verseau is now ready to emerge from stealth with its lead pro­gram. Equipped with $50 mil­lion from 20/20 Health­Care Part­ners, 3SBio, Alexan­dria Ven­ture In­vest­ments, High­light Cap­i­tal, In­Harv Part­ners, The Mark Foun­da­tion for Can­cer Re­search and Yonghua Cap­i­tal, the biotech aims to bring their first macrophage check­point mod­u­la­tor (MCM) to the clin­ic.

George Golumbes­ki

The tar­get, PS­GL-1, is one of 23 that Verseau has iden­ti­fied as mas­ter switch­es that ad­dress the func­tion of macrophages more ful­ly than the an­ti-CD47 par­ty has. While Bunt said she’s had dis­cus­sions with Irv Weiss­man and ap­plaud the work he and oth­ers have done in the field, their ap­proach on­ly scratch­es the sur­face.

George Golumbes­ki, the for­mer BD chief at Cel­gene who’s kept him­self busy with a string of board chair po­si­tions, of­fered a ring­ing en­dorse­ment of this ap­proach as he jumps in to lead the board.

“The fo­cus on myeloid cells as an av­enue to broad­en the ther­a­peu­tic po­ten­tial of im­munother­a­py is emerg­ing quick­ly, and Verseau is po­si­tioned to make a sig­nif­i­cant im­pact on this field,” said Golumbes­ki, Chair­man of the Board of Verseau. “The ear­ly da­ta are im­pres­sive and sug­gest that macrophage-tar­get­ed ther­a­peu­tics may be­come a sig­nif­i­cant ad­vance in im­munother­a­py.”

Ig­or Feld­man

While to­day marks Verseau’s of­fi­cial com­ing-out par­ty, avid biotech news read­ers may re­mem­ber that in Feb­ru­ary Chi­na’s 3SBio an­nounced it’s li­censed rights to three an­ti­bod­ies from the Boston-based start­up. That was a some­what awk­ward sit­u­a­tion of putting the car­riage in front of the horse, but now that she is free to speak about it Bunt is clear­ly pleased about se­cur­ing a Chi­na deal ear­ly in Verseau’s life — an un­con­ven­tion­al route of ob­tain­ing de­vel­op­ment cap­i­tal.

“Chi­na is a ter­rif­ic mar­ket — I’m there 4 times a year — but you need lo­cal part­ners if you need to con­quer that mar­ket,” she said.

Ta­tiana Novo­brant­se­va

3SBio’s man­u­fac­tur­ing ca­pa­bil­i­ties were ap­peal­ing, as was their will­ing­ness to shoul­der some pre­clin­i­cal and clin­i­cal work, which could start to pave the way to par­al­lel reg­u­la­to­ry fil­ings in the US and Chi­na.

Bunt’s state­side team of 32 re­cent­ly re­lo­cat­ed to a big­ger lab in Bed­ford, MA to ac­com­mo­date the un­ex­pect­ed­ly speedy growth, and they an­tic­i­pate hir­ing will at a fast clip.

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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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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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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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.

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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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.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.