Re­gen­eron leaps in­to the block­buster race to de­vel­op off-the-shelf im­mune cell can­cer ther­a­pies

A year ago, Sanofi agreed to pay Re­gen­eron $1.8 bil­lion-plus to part­ner on its an­ti-PD1 check­point pro­gram. To­day, biotech heavy­weight Re­gen­eron is jump­ing in­to CAR-Ts and TCR tech, de­ter­mined to leap di­rect­ly in­to a block­buster brawl with a plan to emerge as a leader in the fast-grow­ing im­muno-on­col­o­gy field. And it’s made the lat­est in a hand­ful of rare biotech deals to part­ner on the tech­nol­o­gy it needs.

Re­gen­eron se­lect­ed the start­up Adicet Bio for its col­lab­o­ra­tion. A new face in im­muno-on­col­o­gy, the biotech popped up on­ly last Jan­u­ary with a hefty $51 mil­lion A round to get start­ed. But it’s helmed by Aya Jakobovits, the found­ing pres­i­dent and CEO of Kite Phar­ma, a leader in de­vel­op­ing per­son­al­ized CAR-Ts.

Aya Jakobovits, Adicet Bio

If it was any oth­er biotech oth­er than Re­gen­eron, the news might spur a lit­tle mock­ing from some of the side­line ob­servers who have been watch­ing the fron­trun­ners present a slate of top per­son­al­ized CAR-Ts down the fi­nal stretch to a like­ly near-term set of ap­provals. It may ap­pear late to the par­ty, but Re­gen­eron is a top in­dus­try R&D play­er; a ma­jor biotech out­fit that is well fi­nanced, re­lent­less­ly fo­cused with a track record that now in­cludes a list of ma­jor drugs that are ei­ther on the mar­ket or close to it. And it’s look­ing to catch the next wave form­ing off­shore of I/O.

Jakobovits gets a mod­est $25 mil­lion up­front to get start­ed on en­gi­neer­ing a pipeline of im­mune cells with chimeric anti­gen re­cep­tors and T cell re­cep­tors, a one-two ap­proach aimed at ze­ro­ing in on both sur­face anti­gens found specif­i­cal­ly on tar­get­ed can­cer cells as well as in­tra­cel­lu­lar tar­gets. There’s a sup­port pack­age for re­search as well, with ad­di­tion­al funds to back up the col­lab­o­ra­tion, but no one is dis­clos­ing any of that this morn­ing.

Both com­pa­nies em­pha­size that they’re con­cen­trat­ing on off-the-shelf drugs that will be pri­mar­i­ly fo­cused on sol­id tu­mors, the new new thing in im­muno-on­col­o­gy where first-gen hema­to­log­i­cal im­munother­a­pies have en­coun­tered hard bar­ri­ers.

“There’s a lot of room left to wind up as a leader,” says Michael Aber­man, the strat­e­gy ex­ec at Re­gen­eron. His com­pa­ny wasn’t the first to tack­le check­points, nor the first in cell ther­a­pies. But “it’s very ear­ly in the first wave to know how that’s go­ing to play out. There’s a lot of chal­lenges left ahead and a lot of op­por­tu­ni­ties. And we’re talk­ing a nov­el ap­proach.”

The pact with Re­gen­eron cov­ers a “broad pipeline,” Jakobovits tells End­points, em­pha­siz­ing that the key to cre­at­ing a safe, ef­fec­tive im­mune cell ther­a­py is be­ing “spe­cif­ic to the tu­mor tar­get.” But Jakobovits, who set up the com­pa­ny as a part­ner at Or­bimed, is very care­ful to stay in­side some nar­row bound­aries on ex­plain­ing ex­act­ly what dis­tin­guish­es their work.

I/O in­vest­ment spe­cial­ist Brad Lon­car says the deal high­lights some key points. Re­gen­eron, he says:

1) Sees the promise in cell ther­a­py, which not all com­pa­nies do. For ex­am­ple, Gilead’s CEO said the idea makes him very un­com­fort­able. Many bears be­lieve it will nev­er be com­mer­cial­ly vi­able. So for a com­pa­ny with the sci­en­tif­ic cred­i­bil­i­ty of Re­gen­eron to take a small dive in says some­thing.

2) Un­der­stands that it’s too late to be a play­er in the au­tol­o­gous (per­son­al­ized) ap­proach or doesn’t be­lieve it can be eco­nom­i­cal­ly vi­able. All of the com­mer­cial op­por­tu­ni­ty has al­ready been tak­en up by ex­ist­ing play­ers.

3) Be­lieves the off the shelf ap­proach is sci­en­tif­i­cal­ly vi­able, which not every­one does.

I’d say the main point is that it’s a good sign for the whole field of cell ther­a­py when a com­pa­ny as cred­i­ble as Re­gen­eron feels like they need to be a play­er in this area. Most peo­ple don’t ap­pre­ci­ate the fact that cell ther­a­py is ba­si­cal­ly ver­sion 1.0 right now and there are many im­prove­ments that will be made over the com­ing years. It has the chance to be very spe­cial and I’m sure Re­gen­eron sees that.

A tech­nol­o­gy arms race of a kind has tak­en shape as var­i­ous com­pa­nies sort out how off-the-shelf ther­a­pies can even­tu­al­ly re­place the first gen­er­a­tion lab-craft­ed per­son­al­ized ther­a­pies that ex­tract cells from pa­tients, reengi­neer them in­to can­cer treat­ments and the in­fuse them back in­to pa­tients. Just days ago Jakobovits’s for­mer com­pa­ny Kite ex­e­cut­ed a deal with UCLA for al­lo­gene­ic tech from the lab of Gay M. Crooks.

Re­gen­eron’s not-so-se­cret weapon in the new front on can­cer in­cludes its unique Ve­locIm­mune mouse mod­els, which are de­scribed as “the largest mam­malian ge­net­ic en­gi­neer­ing project ever ac­com­plished.” It helped them de­vel­op REGN1979, a bis­pe­cif­ic an­ti­body ther­a­py that R&D chief George Yan­copou­los has high­light­ed ex­cit­ed­ly for its abil­i­ty to tar­get the B cell mark­er, CD20, and the CD3 com­po­nent of the T cell re­cep­tor, which trig­gers redi­rect­ed killing of B cells. Its an­ti-PD-1 an­ti­body is REGN2810. Any tar­get­ing mol­e­cules that come out of this new col­lab­o­ra­tion can be redi­rect­ed in­to any oth­er pro­grams Re­gen­eron has, in­clud­ing its pact with Sanofi.

Re­gen­eron doesn’t do many of these pacts, says Aber­man. There was the In­tel­lia deal back in April that brings CRISPR-Cas9 gene edit­ing tech, Avalanche’s gene ther­a­py pact, and now Adicet. But they ex­pect a lot out of the few deals they do with the se­lect biotechs they want to work with.

For Jakobovits, the deal al­so al­lows her to push the quick ex­pan­sion of he new biotech. The staff of 14 is slat­ed to dou­ble, with ad­di­tion­al in­put com­ing from her Is­raeli sub­sidiary.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Some­times you win. Some­times you lose. And some­times it's just an­oth­er PhI­II canakinum­ab fail

At this stage of the game, Novartis CEO Vas Narasimhan may be wishing he’d never even heard of canakinumab.

After steering the drug straight to an FDA rejection as a heart drug, no cheap shot after testing it in 10,000 patients, the Novartis team picked up on an unusual cancer signal — and has now followed it over their third successive cliff to a decisive Phase III flop.

It’s safe to say the game was already all over except for the readout.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Ab­b­Vie calls off PhI tri­al for I-Mab’s CD47 days af­ter Zai Lab shelves its own pro­gram

The CD47 field ran into another hurdle Tuesday as I-Mab quietly disclosed in an SEC filing that AbbVie is saying goodbye to a Phase I study of the biotech’s drug.

Weeks after ending an exploratory trial of I-Mab’s CD47 antibody, AbbVie has now called it quits on another early-stage trial. The Phase I was testing the drug, lemzoparlimab, in combination with azacitidine and venetoclax in patients with acute myeloid leukemia and myelodysplastic syndrome.

Bris­tol My­ers gets nec­es­sary clear­ance for $4.1B Turn­ing Point ac­qui­si­tion

After a brief delay, Bristol Myers Squibb is finally about to close on its $4.1 billion Turning Point acquisition.

BMS announced on Tuesday that it has received merger control clearance from the Federal Cartel Office of Germany, and expects to close on the deal tomorrow. The pharma giant struck a deal earlier this summer to snatch up all outstanding Turning Point shares for $76 apiece, or a total of $4.1 billion. Turning Point’s stock $TPTX more than doubled on the news back in June, and has remained practically level since.

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Chris Sheldon, AstraZeneca's former VP and head of investor relations

As­traZeneca files law­suit against for­mer ex­ec as he jumps to GSK

AstraZeneca and GSK are once again wrangling over talent.

The British pharma giant has filed suit against former VP and head of investor relations Chris Sheldon as he prepares to start a new job at its rival next month. AstraZeneca argued in a London court filing that Sheldon would be violating a non-compete agreement, which he was paid more than $774,000 in shares to sign back in 2021, Bloomberg reported.

What’s in mon­key­pox names? His­to­ry, tra­di­tion­al con­ven­tion and even sit­com sug­ges­tions

The Covid-19 pandemic and rush to vaccines created a stir with a raft of unusual and media-debated names including Moderna’s Spikevax, Pfizer’s Comirnaty and AstraZeneca’s Vaxzevria.

Now monkeypox drug names are in the news — although both the leading vaccine Jynneos and the special use treatment Tpoxx have been around for years. Jynneos was approved as protection against smallpox and monkeypox in 2019, while Tpoxx was approved as an antiviral to treat smallpox in 2018.

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Mar­ket­ingRx roundup: Ho­log­ic taps fa­mous singer again for women’s health screens; HIV drug mak­ers pitch in to raise aware­ness for mon­key­pox

After a splashy Super Bowl TV ad starring celebrity spokesperson singer Mary J. Blige, Hologic is back again with its Grammy-award winner partner in a new campaign to encourage women to stay up to date on well visits and screenings.

The promotion called “Good Morning Gorgeous” is connected to Hologic’s sponsorship of Blige’s national music tour by the same name on the road from mid-September through the end of October. The campaign includes a new public service announcement set to be shown at the concert venues — including Atlanta, Chicago, Detroit, Philadelphia and Washington, DC — and a sweepstakes to win tickets in the month leading up to its run.

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FDA grants pri­or­i­ty re­view to Lyn­parza com­bo ther­a­py for metasta­t­ic prostate can­cer

AstraZeneca and Merck’s top-selling PARP inhibitor Lynparza is possibly on its way to winning regulatory approval for yet another indication.

The FDA has accepted the supplemental new drug application and granted a priority review to Lynparza combination therapy for patients with metastatic castration-resistant prostate cancer, the companies announced Tuesday.

In the US, prostate cancer is the second most common cancer in male patients, and nearly 10-20% of men with advanced prostate cancer are estimated to develop castration-resistant prostate cancer.