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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Al Sandrock, Voyager Therapeutics CEO

Af­ter 12 months of dig­ging, Pfiz­er opts for one of two Voy­ager cap­sids for gene ther­a­py

The path at Voyager Therapeutics keeps winding, and at the 12-month deadline, Pfizer has elected to only move forward with one of two capsids out of the preclinical biotech for the Big Pharma’s AAV gene therapies.

Last October, the Big Pharma and biotech linked arms on a deal that gave Pfizer the ability to hit the gas pedal on two capsids: one for a cardiac target and the other for a rare neurologic disease target.

User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

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