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.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

Anthony Fauci, AP Images

First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

Mallinck­rodt, once the na­tion’s largest oxy­codone pro­duc­er, an­nounces ten­ta­tive $1.6B set­tle­ment

Three years after it first paid out fines for its role in the US opioid abuse epidemic, Mallinckrodt has announced an agreement-in-principle that will see the company pay out $1.6 billion and place its generics unit in bankruptcy.

The tentative deal would settle hundreds of lawsuits from state and local governments over Mallinckrodt’s role in the epidemic, while also helping address the company’s increasingly mountainous debt. Although Purdue Pharma has drawn the bulk of both public and legal acrimony for opioid sales, documents made public earlier this year showed that Mallinckrodt subsidiary SpecGx, along with the generic subsidiaries of Teva and Endo Pharmaceuticals, accounted for the vast majority of the 76 billion opioid pills distributed from 2006 to 2012. Mallinckrodt was at the top of that list.