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.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.