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

Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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J&J team shows off 'break­through' BC­MA CAR-T da­ta, and that could cause a big headache at blue­bird and Bris­tol-My­ers

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off of the multiple myeloma data for JNJ-4528 that impressed the FDA. And it’s easy to see why they may well be on a short path to a landmark approval — which may well be making the rival team at bluebird/Bristol-Myers more than a little nervous.

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J&J's Mathai Mammen at an Endpoints News event in Boston, June 2018 (Photo: Rob Tannenbaum for Endpoints News)

J&J fronts $750M cash to grab a failed can­cer drug that’s been re­pur­posed as a pow­er­ful an­ti-in­flam­ma­to­ry

J&J has stepped up with one of its blockbuster drug buys, agreeing to pay Austin-based XBiotech $XBIT $750 million in cash and up to $600 million more in milestones for their late stage-ready anti-inflammatory drug bermekimab — which some longtime biotech observers may recognize as a failed cancer therapy with a disaster-prone past.

The drug targets the IL-1a pathway. J&J $JNJ R&D chief Mathai Mammen is cutting a check for a drug that has produced positive mid-stage data in patients suffering from a skin condition called hidradenitis suppurativa with another mid-stage program underway for atopic dermatitis.

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One of Wall Street’s most high-pro­file hedge funds push­es Alex­ion's CEO to the auc­tion block — and he's not budg­ing

Fresh off buying Barnes & Noble and prodding AT&T with some heavy-handed criticism after picking up a $3.2 billion stake in the company, the activist — and supremely high profile — hedge fund Elliott Management has stepped up with some M&A advice for Alexion’s management team.
And the execs on the team $ALXN are giving them a polite — but very firm — stiff arm Friday morning.
In a release out early Friday, the big biotech said that the Elliott team had been in touch to encourage them to sell the company. But that’s not on the agenda.

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Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

I want to give readers a quick update on the most important part of our business model — premium subscriptions. We have some crucial financial goals we hope to achieve by the end of the year, and the team here in Lawrence is ready to ship some swag to kick off this limited December promotion.

We offer two premium plans — Enterprise for companies ($1,000/year, unlimited people), and Insider for individuals ($200/year). This month of December will be the last chance to enroll at the original rates — which have remained flat since we launched them in 2017.

Jasper Ther­a­peu­tics launch­es out of Stan­ford with new ap­proach to stem cell treat­ment

The first girl in the trial came in with chronic diarrhea and the immune system of an untreated HIV patient. Born with a rare genetic disease that impeded her ability to make B and T cells, she had once been given a stem cell transplant but it didn’t take.  Back in the hospital, she was injected with a new experimental antibody and then given a new stem cell transplant. Soon, she gained weight. The diarrhea stopped.

Ex-Cel­gene ex­ec Ter­rie Cur­ran puts her Phath­om team in place; Car­away taps Mar­tin Williams as CEO

→ Gastrointestinal disease-focused Phathom Pharmaceuticals has shaken up its leadership team. The company has tapped former Celgene exec Terrie Curran as CEO, succeeding David Socks, who is transitioning to interim CFO. Curran was president of Celgene’s global inflammation and immunology franchise — helping with the sale of Otezla for $13.4 billion to Amgen — and has held a previous stint at Merck. In addition to Curran, the company also welcomed former Omeros CMO Eckhard Leifke as CMO, ex-Celgene exec Joseph Hand as chief administrative officer, and former general counsel for Cyclerion Therapeutics Larry Miller as general counsel. They also replaced Chris Slavinsky on the board with Takeda exec Asit Parikh.

UCB buffs up in block­buster pso­ri­a­sis race as bimek­izum­ab beats Hu­mi­ra in head-to-head

Just weeks after boasting head-to-head victories over first placebo and then J&J’s IL-23 contender Stelara in clearing psoriasis, the results are in for UCB’s last Phase III trial, in which bimekizumab went up against the world’s best-selling drug.

Only topline results are provided for today’s readout of the BE SURE study, so we won’t find out just how superior bimekizumab proved against Humira on the co-primary endpoints — standard scores known as PASI90 and IGA measuring the impact and severity of the disease — until a scientific conference in 2020.

With EMA re­view in progress, No­var­tis un­veils more pos­i­tive da­ta on asth­ma ther­a­py

Having made its marketing pitch to the EU regulator, Novartis on Thursday unveiled positive pivotal study data supporting the use of its inhaled asthma treatment.

The therapy, QMF149, consists of the long-acting beta-agonist, or LABA, called indacaterol acetate and the corticosteroid mometasone furoate. In the 2,216-patient, 52-week PALLADIUM study, asthma patients either received a medium or high dose of the Novartis therapy (150/160 μg; 150/320 μg) or mometasone furoate (MF) alone.