Tariq Kassum, Celsius CEO

Cel­sius aims to cool down in­flam­ma­tion with new in­vestors and more phar­ma deals

Broad In­sti­tute spin­out Cel­sius Ther­a­peu­tics is turn­ing up the heat on the fi­nanc­ing front as it looks to ice the symp­toms of in­flam­ma­to­ry bow­el dis­ease.

The Cam­bridge, MA biotech has added $83 mil­lion in new fi­nanc­ing — a mix­ture of a Se­ries A ex­ten­sion and Se­ries B funds — to chase its vi­sion of pre­ci­sion ther­a­pies across au­toim­mune dis­eases and can­cer. The Third Rock- and GV-backed start­up, found­ed in 2018, brought in new in­vestors like Am­gen Ven­tures, Am­pli­tude Ven­tures and Fast Track Ini­tia­tive.

Keep an eye on Fast Track, the Tokyo VC firm that’s “very plugged in­to Japan­ese phar­ma com­pa­nies and the Japan­ese busi­ness en­vi­ron­ment,” Cel­sius CEO Tariq Kas­sum told End­points News. Pri­or to his roles at Cel­sius and Ob­sid­i­an Ther­a­peu­tics, Kas­sum held mul­ti­ple di­rec­tor and se­nior di­rec­tor po­si­tions at Take­da and its Mil­len­ni­um unit from 2009 to 2016.

“Cer­tain­ly from my ex­pe­ri­ence at Take­da, I have a lot of re­spect for” phar­mas and aca­d­e­m­ic in­sti­tu­tions in Japan, Kas­sum said. Cel­sius is “talk­ing to all kinds of phar­ma com­pa­nies” about part­ner­ships, in­clud­ing ones in Japan, the CEO added.

Cel­sius will de­ploy the new funds on bring­ing its first treat­ment in­to the clin­ic in ear­ly 2023. The first stop? IBD. On­ly 20% to 30% of pa­tients ex­pe­ri­ence sus­tained re­mis­sion from ap­proved drugs in the IBD space, Kas­sum said.

In steps Cel­sius’ an­ti-TREM-1 an­ti­body, named CEL383. Af­ter an ini­tial healthy vol­un­teer study, Cel­sius wants to en­able “pa­tient se­lec­tion and pa­tient strat­i­fi­ca­tion,” as part of its pre­ci­sion ther­a­peu­tics mis­sion for the drug, Kas­sum said. He not­ed the pre­ci­sion med­i­cine the­sis of Cas­din Cap­i­tal, the Se­ries B lead in­vestor.

“The fu­ture of treat­ment of au­toim­mune dis­ease is be­ing able to iden­ti­fy sub­sets of pa­tients who can re­spond to your ther­a­py,” the CEO said.

Cel­sius chose TREM-1 based on the biotech’s sin­gle-cell analy­sis on hun­dreds of clin­i­cal sam­ples, which is the re­sult of col­lab­o­ra­tions with the Uni­ver­si­ty of Ox­ford, Cleve­land Clin­ic, LMU Uni­ver­si­ty Hos­pi­tal Mu­nich and oth­er aca­d­e­m­ic in­sti­tu­tions. The myeloid tar­get plays a role in IBD by boost­ing in­flam­ma­tion “at the in­ter­sec­tion of the mi­cro­bio­me and the im­mune sys­tem,” the com­pa­ny said.

TREM-1 is the ba­sis of French start­up In­otrem, which is study­ing nan­gi­botide, an in­hibitor of the path­way, in mul­ti­ple mid-stage stud­ies in pa­tients with sep­tic shock and Covid-19. In­otrem is ex­pand­ing its an­ti-TREM-1 work with a mon­o­clon­al an­ti­body, yet to be test­ed in hu­mans. Al­so in the TREM-1 space is Pi­o­nyr, half-owned by Gilead, which is test­ing a mAb in pa­tients with ad­vanced sol­id tu­mors in a Phase Ia/Ib study.

On the part­ner­ship side, Cel­sius said Thurs­day that it’s made progress on its $700 mil­lion col­orec­tal can­cer col­lab­o­ra­tion with Servi­er. The French phar­ma has se­lect­ed the first tar­get can­di­date in the three-pro­gram deal, a step that pro­vides “great val­i­da­tion” for Cel­sius’ plat­form, Kas­sum said.

Cel­sius al­so has a part­ner­ship with J&J’s Janssen, but the biotech is more tight-lipped about this tie-up. Kas­sum said Cel­sius is per­form­ing analy­ses on cer­tain Janssen clin­i­cal tri­als, de­clin­ing to dis­close which ones. The com­pa­nies said in Ju­ly 2019 that Cel­sius would use sin­gle-cell ge­nomics and ma­chine learn­ing to “iden­ti­fy pre­dic­tive bio­mark­ers of re­sponse” in Janssen’s Phase IIa VE­GA study.

That tri­al showed a com­bo ther­a­py of Trem­fya and Sim­poni ARIA led to bet­ter clin­i­cal re­sponse at week 12 ver­sus ei­ther as a so­lo treat­ment in pa­tients with ul­cer­a­tive col­i­tis, Janssen said last month.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

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.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

Neil Desai, Aadi Bioscience CEO (via YouTube)

Pre­ci­sion on­col­o­gy biotech agrees to $72M cash in­fu­sion as it seeks to in­crease rev­enue

Almost a year after the FDA gave the green light to LA-based Aadi Bioscience’s first drug, the biotech is looking to private investors to keep itself going.

The oncology player announced Thursday that it has engaged with both new and existing investors in a PIPE financing — selling 3.3 million shares at $12.50 a share, the biotech’s closing price at Nasdaq on Wednesday. The company is also selling off pre-funded warrants to purchase over 2.4 million more shares at $12.4999 per pre-funded warrant.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.