With PD-1 OK loom­ing, Re­gen­eron antes $100M on blue­bird al­liance for next-gen TCR cell ther­a­py pact

Some­time in the next few months, we’re like­ly to see the FDA come through with an ap­proval for the world’s 6th PD-1/L1 check­point in­hibitor from Re­gen­eron $REGN and its long­time de­vel­op­ment part­ners at Sanofi. But now the fast-grow­ing Re­gen­eron is al­so al­ly­ing it­self with blue­bird bio $BLUE, putting up $100 mil­lion in eq­ui­ty cash on a 50/50 de­vel­op­ment deal aimed at cre­at­ing a new pipeline of cell ther­a­pies with an eye to ex­pand­ing the hori­zon in on­col­o­gy with a new set of T cell re­cep­tor tar­gets.

The top sci­en­tists at blue­bird and Re­gen­eron took time Sun­day to pre­view a deal that moves the small­er com­pa­ny well past the BC­MA pro­gram it has put in the spot­light, while the an­ti­body de­vel­op­ment ex­perts at Re­gen­eron work their tech plat­form for 6 undis­closed tar­gets used to kick off the 5-year al­liance.

The mar­ket loved the idea, send­ing blue­bird’s shares up 7% in pre-mar­ket trad­ing.

In a typ­i­cal al­liance in­volv­ing a big­ger com­pa­ny, says Re­gen­eron R&D chief George Yan­copou­los, mak­ing a stren­u­ous ef­fort to dis­tin­guish this deal from the pack, you see a dom­i­nant play­er look­ing to add a par­tic­u­lar kind of ex­per­i­men­tal drug to the pipeline.

This isn’t that kind of deal.

“When I say we’re in­ter­est­ed in blue­bird bio,” says the Re­gen­eron co-founder, “it wasn’t for any par­tic­u­lar can­di­date.”

Philip Gre­go­ry

In­stead, says blue­bird CSO Phil Gre­go­ry, this is about a CAR-T and gene ther­a­py ex­pert, blue­bird, al­ly­ing it­self with a com­pa­ny that makes “the best binders that ex­ist.”

“Both com­pa­nies are en­tire­ly all in,” from the CEO on down, adds Yan­copou­los with all the in­ten­si­ty the in­dus­try has come to ex­pect from one of the most pro­duc­tive — and best paid — R&D di­rec­tors in the in­dus­try. “This is a ma­jor fo­cus for us.”

Re­gen­eron orig­i­nat­ed the idea, he adds, and made it hap­pen with a $100 mil­lion up­front for an eq­ui­ty stake in blue­bird, with a hefty pre­mi­um built in to blue­bird’s al­ready con­sid­er­able stock price.  But it’s not splurg­ing. Re­gen­eron’s price bakes in a $37 mil­lion pre­mi­um, which will be used to pay for its first round of re­search costs in the part­ner­ship.

For Re­gen­eron and blue­bird, it’s a chance to con­sid­er­ably widen the hori­zon of cell ther­a­py tar­gets — adding a va­ri­ety of in­tra­cel­lu­lar TCR tar­gets. And blue­bird fat­tens a cash re­serve that was re­cent­ly built up with a whop­ping $632 mil­lion raise, as it looks to tran­si­tion to a com­mer­cial stage with an up­com­ing fil­ing on β-tha­lassemia and more da­ta for bb2121.

The part­ners built the terms for a marathon pact, run­ning ini­tial­ly for 5 years but with terms that would al­low them to con­tin­ue to move on in cre­at­ing a pipeline to­geth­er. I asked the usu­al ques­tions. What are the first tar­gets? When will they make it to the clin­ic and in­to hu­man pa­tients?

Not sur­pris­ing­ly, those cards will re­main close to the vest for now. But both com­pa­nies are well known for a fo­cus on prod­ucts and per­for­mance. So it’s not an in­def­i­nite si­lence.

As both com­pa­nies close in on the on­col­o­gy mar­ket, where a myr­i­ad of con­tenders are look­ing to make their mark, they’re sat­is­fied to­day that they are stronger to­geth­er, than apart.

Im­age: George Yan­copou­los. GET­TY IM­AGES

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Merdad Parsey, Gilead CMO

Four months af­ter CRL due to con­t­a­m­i­nant wor­ries, Gilead re­turns to FDA for next-gen HIV drug

Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two.

Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.”

Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.