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.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.