Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Sanofi en­lists Ada­gene and its 'mask­ing' tech to de­vel­op new I/O drugs, in a deal po­ten­tial­ly worth $2.5B

Sanofi is putting to­geth­er a new, multi­bil­lion dol­lar deal aim­ing to leap in­to the next gen­er­a­tion of im­muno-on­col­o­gy.

The French phar­ma signed a col­lab­o­ra­tion with Ada­gene on Tues­day to ad­vance two pre­clin­i­cal I/O can­di­dates, and an op­tion to de­vel­op two more. Sanofi is pony­ing up $17.5 mil­lion up­front and promis­ing up to $2.5 bil­lion in po­ten­tial mile­stones.

The deal is slight­ly un­ortho­dox rel­a­tive to how these deals usu­al­ly shake out, as both of the ini­tial pro­grams come from Sanofi’s de­vel­op­ment pipeline — not Ada­gene’s. But the com­pa­nies are aim­ing to link those com­pounds to what Ada­gene calls a “mask­ing” tech­nol­o­gy that can bet­ter se­lec­tive­ly tar­get tu­mor mi­croen­vi­ron­ments than cur­rent ap­proach­es.

For Sanofi, can­cer drugs are noth­ing new.

The big drug­mak­er has been slow­ly adding im­muno-on­col­o­gy as­sets over the past few years, no­tably buy­ing out the ar­ti­fi­cial cy­tokine start­up Syn­thorx for $2.5 bil­lion in 2019 and adding a dif­fer­ent an­ti­body “mask­ing” com­pa­ny in Amu­nix last year for $1 bil­lion.

Sanofi al­so owns Lib­tayo with Re­gen­eron, one of the sev­en FDA-ap­proved PD-(L)1 an­ti­bod­ies that have changed the on­col­o­gy land­scape. Lib­tayo has not seen the fi­nan­cial suc­cess­es of gi­ants like Mer­ck’s Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo, how­ev­er: its first ap­proval came in 2018 and it on­ly achieved its sec­ond ap­proval in 2021, notch­ing two in the span of a cou­ple weeks last Feb­ru­ary.

Though Lib­tayo sales near­ly dou­bled last year com­pared to 2020, the drug still on­ly pulled in about $143 mil­lion — a far cry from Keytru­da’s $17 bil­lion-plus. And there may be more trou­ble afoot as Sanofi and Re­gen­eron pulled an sN­DA in cer­vi­cal can­cer this Jan­u­ary af­ter they couldn’t agree with the FDA on post-mar­ket­ing stud­ies.

Sanofi has seen some­what greater suc­cess with an­oth­er drug, Sar­clisa, a CD38-tar­get­ing mon­o­clon­al an­ti­body for mul­ti­ple myelo­ma. It’s be­ing po­si­tioned as a po­ten­tial com­peti­tor to J&J’s long­time gi­ant Darza­lex, and though Sar­clisa sales grew a whop­ping 318% over 2020 to rough­ly $195 mil­lion, J&J has con­tin­ued to press its ad­van­tage with a new sub­cu­ta­neous ap­proval late last year.

Pe­ter Luo

Tues­day’s deal with Ada­gene is os­ten­si­bly about how Sanofi plans to chart its next gen­er­a­tion of can­cer drugs. The com­pa­nies aren’t say­ing any­thing about the tar­gets just yet, but Ada­gene CEO Pe­ter Luo told End­points News the mask­ing tech is not re­strict­ed to any spe­cif­ic kind of drug.

It’s a plat­form he says has al­ready been val­i­dat­ed through some of Ada­gene’s oth­er pro­grams, in­clud­ing one in the clin­ic and two more in the IND-en­abling phase. The “mask­ing” works by es­sen­tial­ly putting a seat belt on the an­ti­bod­ies, Luo said, pro­tect­ing healthy tis­sue from what he de­scribes as the an­ti­body’s ex­treme po­ten­cy.

And once the an­ti­bod­ies reach the tu­mor mi­croen­vi­ron­ments, they’re able to ac­ti­vate as Ada­gene’s tech­nol­o­gy rec­og­nizes cer­tain over- or un­der­ex­pressed en­zymes found on­ly in these en­vi­ron­ments.

When tu­mors are di­gest­ing healthy tis­sue, Luo said, the di­ges­tion “goes through some en­zymes which can ac­ti­vate in the tu­mor mi­croen­vi­ron­ments. But in ad­di­tion to that, our mask­ing tech­nol­o­gy us­es oth­er mech­a­nisms we call pre­ci­sion mask­ing, dy­nam­ic mod­u­la­tion and oth­er mech­a­nisms. So this re­al­ly al­lows us to tap in­to this di­verse mech­a­nism to al­low us to ac­ti­vate the [tech­nol­o­gy] in the tu­mor mi­croen­vi­ron­ment ver­sus nor­mal tis­sues.”

Ada­gene is seem­ing­ly hop­ing this deal will re­verse its for­tunes on the mar­ket. Af­ter de­but­ing on Nas­daq last Feb­ru­ary with a $140 mil­lion IPO, the com­pa­ny’s shares $ADAG closed Mon­day down 80% from its all-time high. Ada­gene al­so signed a deal with Ex­elix­is to pair the mask­ing tech to an­ti­body-drug con­ju­gates in Feb­ru­ary of last year.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

Endpoints Premium

Premium subscription required

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

Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,800+ biopharma pros reading Endpoints daily — and it's free.

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

Endpoints Premium

Premium subscription required

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

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

Endpoints Premium

Premium subscription required

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

Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,800+ biopharma pros reading Endpoints daily — and it's free.

Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,800+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers scraps gene ther­a­py deal with uniQure for car­dio­vas­cu­lar dis­eases

Bristol Myers Squibb is hitting the exit on a collaboration with a gene therapy biotech.

The Big Pharma company will no longer partner with uniQure on finding new treatments for cardiovascular diseases, the biotech reported to the SEC last week, following a rocky relationship that saw the pair break off an earlier agreement — before coming back to the table. The deal will officially terminate on Feb. 21, 2023.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,800+ biopharma pros reading Endpoints daily — and it's free.

Jeb Keiper, Nimbus Therapeutics CEO

PhI­Ib win puts Nim­bus one step clos­er to chal­leng­ing Bris­tol My­ers in TYK2

Bristol Myers Squibb might be the first to clinch an FDA approval for a TYK2 inhibitor, but Nimbus Therapeutics is out to prove that it has the best drug in the class. The biotech says it now has positive mid-stage data to back up those claims — although it’s saving the hard numbers for now.

Topline results from a Phase IIb study involving 259 patients with moderate-to-severe plaque psoriasis showed that Nimbus’ drug, NDI-034858, hit the primary endpoint of helping more patients achieve PASI-75 than placebo at 12 weeks.

John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

Endpoints Premium

Premium subscription required

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