Steven Kelly, Carisma CEO and president

Caris­ma's CAR-M steals spot­light among 42 bid­ders to re­verse merge with Sesen Bio

Sesen Bio’s decade-plus jour­ney is over af­ter fail­ing to se­cure a blad­der can­cer drug ap­proval and carve its own path for IL-6 an­ti­bod­ies. The Cam­bridge, MA com­pa­ny’s spot on Nas­daq will serve as the new home for Caris­ma Ther­a­peu­tics, which is at­tempt­ing to ush­er in a new CAR cell ther­a­py in the world of macrophages and mono­cytes.

The two are ex­e­cut­ing an all-stock re­verse merg­er, with the fu­ture rest­ing sole­ly on Caris­ma’s line­up of ther­a­pies, in­clud­ing a Phase I as­set that had some lim­it­ed da­ta pre­sent­ed at AS­CO in June. The Philadel­phia start­up will be­gin trad­ing un­der the apt­ly sym­bol­ed tick­er $CARM in three to four months, the com­pa­nies said Wednes­day morn­ing.

Thomas Can­nell

Caris­ma beat out 41 oth­er bid­ders, Sesen CEO and pres­i­dent Thomas Can­nell said in a state­ment, not­ing the merg­er part­ner “has the sci­ence and the un­wa­ver­ing pa­tient fo­cus re­quired” to bet­ter the lives of can­cer pa­tients. The Penn-found­ed start­up has al­so lined up its own in­vestors to bankroll the new Caris­ma, with $30 mil­lion from Ab­b­Vie, Mer­ck’s ther­a­peu­tics VC arm, Penn Med­i­cine and a host of oth­er back­ers.

In all, Caris­ma will have $180 mil­lion to bring mul­ti­ple ther­a­pies to clin­i­cal read­outs and keep the lights on through 2024, the com­pa­nies said. The first pro­gram, CT-0508, en­tails go­ing af­ter ad­vanced HER2+ sol­id tu­mors with a CAR macrophage cell ther­a­py. No­var­tis is pick­ing up the tech to help man­u­fac­ture the clin­i­cal as­set.

Next in line is a HER2 CAR mono­cyte, which CSO and co-founder Michael Klichin­sky pre­vi­ous­ly char­ac­ter­ized as the pre­cur­sor to the macrophage. And there’s the in vi­vo can­cer cell ther­a­py pact with Mod­er­na, which in­clud­ed $45 mil­lion up­front.

Caris­ma is tak­ing over the stock list­ing of an em­bat­tled Sesen, which has been in rough wa­ters since be­fore the bear mar­ket. Sesen paused the de­vel­op­ment of its blad­der can­cer drug in Ju­ly, af­ter a 2021 FDA re­jec­tion and mul­ti­ple meet­ings there­after, and slashed its work­force. The com­pa­ny al­so ful­ly of­floaded its IL-6 an­ti­bod­ies to Roche for $40 mil­lion up­front and $30 mil­lion more on the line.

Sesen Bio stock­hold­ers will own about 41.7% of the merged com­pa­ny, and Caris­ma stock­hold­ers will get the re­main­ing 58.3%. Caris­ma will re­main in Philadel­phia and keep CEO and pres­i­dent Steven Kel­ly at the helm.

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.

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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.

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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.

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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.

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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.

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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.

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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%.

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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.

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