Col­orec­tal drug can­di­dates fo­cal point of new col­lab­o­ra­tion be­tween Servi­er, Cel­sius Ther­a­peu­tics

A well-known in­ter­na­tion­al phar­ma­ceu­ti­cal com­pa­ny and a rel­a­tive­ly new US pre­ci­sion ther­a­peu­tics start­up are join­ing forces to iden­ti­fy and val­i­date nov­el col­orec­tal can­cer drug tar­gets.

French phar­ma Servi­er and Cam­bridge, MA-based start­up Cel­sius Ther­a­peu­tics will work to­geth­er over a three-year pe­ri­od to re­search, de­vel­op, and com­mer­cial­ize up to three of the most promis­ing col­orec­tal can­cer drug dis­cov­ery tar­gets.

In an in­ter­view with End­points News, Cel­sius CEO Tariq Kas­sum said that with­in the col­orec­tal can­cer dis­ease spec­trum, the num­ber of dif­fer­ent sub­sets of dis­ease make it dif­fi­cult to treat. Some pa­tients, for ex­am­ple, re­spond to ther­a­peu­tics, while some don’t due to what Kas­sum called the “mu­ta­tion­al bur­den” of the can­cer.

Tariq Kas­sum

This is where Cel­sius’ work comes in­to play. The com­pa­ny has a ge­nomics plat­form that al­lows it to study tis­sue at a sin­gle-cell RNA lev­el — mean­ing it can study the dif­fer­ent re­sponse types of col­orec­tal can­cer pa­tients to fig­ure out what ex­act­ly is caus­ing the dis­crep­an­cies.

The lack of a co­he­sive treat­ment re­sponse is one of the most press­ing and un­met med­ical needs for col­orec­tal can­cer pa­tients, Kas­sum said, and that’s why Cel­sius is part­ner­ing with Servi­er in the hopes of ad­vanc­ing drug can­di­dates to the clin­i­cal tri­al stage.

Kas­sum said he and his team have known folks from Servi­er for years, and their work­ing re­la­tion­ship was strong enough that Kas­sum couldn’t re­mem­ber which group ap­proached the oth­er about work­ing to­geth­er.

But Cel­sius’ ge­nomics plat­form be­gan to gain mo­men­tum with­in the last year or so, which al­lowed the col­lab­o­ra­tion to be ini­ti­at­ed in the ear­ly half of 2020 and the fi­nan­cial as­pects of the deal to be worked out in the lat­ter half of the year.

“It’s one of these dis­cus­sion se­ries that had been on­go­ing for some time,” Kas­sum said. “I al­ways say that the num­ber one thing that you can do to pre­dict the suc­cess of bio­phar­ma part­ner­ships is to see what the tone of the ne­go­ti­a­tion was like, and this team was great to work with. It was su­per con­struc­tive and re­al­ly all about prob­lem solv­ing, not about butting heads.”

Terms of the col­lab­o­ra­tion agree­ment dic­tate that Servi­er will re­ceive an ex­clu­sive op­tion to re­search, de­vel­op, and com­mer­cial­ize prod­ucts di­rect­ed to up to three drug tar­gets while Cel­sius will re­ceive an up­front pay­ment and re­search fund­ing, and would be el­i­gi­ble to re­ceive over $700 mil­lion in po­ten­tial  dis­cov­ery, de­vel­op­ment, and com­mer­cial­iza­tion mile­stone pay­ments, along with tiered roy­al­ties from suc­cess­ful can­di­dates.

Servi­er’s glob­al head of on­col­o­gy R&D, Hugues Dol­gos, said in a press re­lease that Cel­sius’ tech­nol­o­gy will al­low Servi­er to dis­cov­er and de­vel­op drug can­di­dates that are even more in tune with the com­pa­ny’s ca­pa­bil­i­ties in small and large mol­e­cules.

“As col­orec­tal can­cer re­mains a lead­ing con­trib­u­tor to can­cer deaths world­wide, we see an ur­gent need to bring for­ward new ther­a­peu­tic op­tions for pa­tients,” Dol­gos said.

Hugues Dol­gos

Though Cel­sius formed on­ly a few years ago, Kas­sum told End­points that the Servi­er col­lab­o­ra­tion shows sim­ply that its tech­nol­o­gy is work­ing and work­ing well to make the in­roads it set out to make.

For ex­am­ple, in ad­di­tion to the on­co­log­i­cal fo­cus of this col­lab­o­ra­tion, Cel­sius al­so has an on­go­ing deal with Janssen to iden­ti­fy re­sponse bio­mark­ers for ul­cer­a­tive col­i­tis and is al­so work­ing on a myr­i­ad of re­search re­lat­ed to in­flam­ma­to­ry bow­el dis­ease.

“Peo­ple who fol­low these things will see that Cel­sius is a com­pa­ny that got launched a cou­ple of years ago with a very am­bi­tious man­date around us­ing sin­gle-cell RNA se­quenc­ing to bet­ter un­der­stand these com­plex dis­eases — can­cers and au­toim­mune dis­ease,” Kas­sum said.

“Where we are to­day is the ma­chine is run­ning. The plat­form is work­ing. But it took a while to get run­ning be­cause it’s ac­tu­al­ly fair­ly com­pli­cat­ed,” he said. “ … I think the thing that’s re­al­ly cool about this is that it’s an ex­ter­nal win­dow in­to show­ing that the ma­chine is up and run­ning.”

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

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In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Luke Miels, GSK chief commercial officer

Lend­ing a hand to a biotech in trou­ble, GSK drops $75M cash to add late-stage an­tibi­ot­ic to port­fo­lio

GSK likes to take pride in being one of the few Big Pharma players still active in antibiotics R&D. And that means keeping tabs on what the field has to offer.

In a move to beef up the late-stage pipeline, GSK is licensing a late-stage antibiotic candidate from Spero Therapeutics. In doing so, it’s coming to the rescue of a struggling biotech that’s crumbled in the wake of an FDA rejection and raised doubts about its ability to carry on.

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David Chang, Allogene CEO (Jeff Rumans)

Servi­er cuts off col­lab­o­ra­tion agree­ment with Al­lo­gene on CD19 prod­ucts, send­ing shares sput­ter­ing

Allogene Therapeutics said in an SEC filing today that French partner Servier has cut off its involvement in a partnership developing therapies directed against CD19, including the most advanced candidates in Allogene’s pipeline.

Shares of Allogene $ALLO, an outfit run by Kite vets Arie Belldegrun and research chief David Chang, fell by almost 10% on Wednesday, even as the San Francisco-based company said that Servier’s discontinuation “does not otherwise affect our current exclusive license for the development and commercialization of CD19 Products in the United States.”

Lina Khan, FTC chair (Graeme Sloan/Sipa USA/Sipa via AP Images)

FTC chair Lina Khan to Sen­ate: Big Phar­ma M&A is still a pri­or­i­ty tar­get

As the Federal Trade Commission has already sought new ideas for analyzing pharma mergers, FTC chair Lina Khan reiterated Tuesday to a Senate subcommittee that reviewing Big Pharma mergers is a priority.

While comparing this merger analysis in the pharma space to the study of public utilities in the 1930s “that exposed rampant financial fraud,” Khan said in prepared testimony that the commission is going to target unlawful conduct.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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