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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Pa­tient re­port finds con­sti­pa­tion con­di­tion not well man­aged, open­ing door for bet­ter ed­u­ca­tion from phar­ma

Advertising for constipation treatments often uses light-hearted humor in an effort to spur open discussions about the sometimes stigmatized topic. However, that may not be enough to get people to take the condition seriously, a new patient report from Phreesia finds.

Fewer than one-fifth (17%) of patients with constipation surveyed understand the longer-term health risks of constipation such as hemorrhoids and bowel incontinence. Many are trying to manage their condition with over-the-counter medicines, but often for much longer than recommended. An equal 68% say they use home remedies or OTC meds to manage constipation. But while 90% understand that OTCs are not intended for long-term use, 50% have used an OTC constipation medicine for more than a year.

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Cell and gene ther­a­pies from acad­e­mia: EMA to help 5 projects go­ing af­ter un­met clin­i­cal needs

The European Medicines Agency said Thursday that it’s launching a new pilot program to help academic and other nonprofit researchers developing advanced therapy medicinal products, which includes cell and gene therapies.

Academics have proven to be enormously useful in feeding new products, like chimeric antigen receptor (CAR)-T cell therapies first developed by Memorial Sloan Kettering, and ushered to the market by biopharma companies. Jean Bennett, formerly with the University of Pennsylvania, also saw her research lead to the approval of gene therapy Luxturna, which Roche now owns.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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