Big names, big com­pa­nies back a cell ther­a­py start­up run by a high-pro­file re­gen­er­a­tive med ex­pert

Robert Hariri

One of the best known names in re­gen­er­a­tive med­i­cine is launch­ing a new biotech with as­sets and cash com­ing from a range of mar­quee com­pa­nies that in­cludes Cel­gene.

The founder of the War­ren, NJ-based up­start is Robert Hariri, a co-founder at Craig Ven­ter’s Hu­man Longevi­ty. Hariri ran An­thro­ge­n­e­sis when Cel­gene bought it out 15 years ago, then head­ed Cel­gene Cel­lu­lar Ther­a­peu­tics for a pe­ri­od. Along the way he de­vel­oped projects us­ing stem cells de­rived from hu­man pla­cen­tas and inked col­lab­o­ra­tions be­tween some of the key play­ers, in­clud­ing Cel­gene.

Now, Hariri says he has gathered to­geth­er pre­clin­i­cal as­sets re­lat­ed to im­muno-on­col­o­gy as well as re­gen­er­a­tive tech for chron­ic and de­gen­er­a­tive dis­eases. He raised an un­spec­i­fied amount of mon­ey from a group that in­cludes Sor­ren­to Ther­a­peu­tics, Unit­ed Ther­a­peu­tics and Hu­man Longevi­ty.

San Diego-based Sor­ren­to passed along some IP on cell ther­a­pies and I/O, while Unit­ed CEO Mar­tine Roth­blatt and Ven­ter both have ex­pressed an avid in­ter­est in an­ti-ag­ing tech­nolo­gies.

Sor­ren­to CEO Hen­ry Ji

While stem cell R&D has gone through its boom and bust pe­ri­od, a num­ber of promi­nent play­ers are tak­ing what they’re learned and head­ed back to the clin­ic, look­ing to suc­ceed where oth­ers have failed. Adding I/O to the mix will al­so help en­hance its im­age.

Hariri clear­ly wants to start out with some big names on the board, which in­cludes for­mer FDA com­mis­sion­er An­drew von Es­chen­bach.

Sor­ren­to CEO Hen­ry Ji not­ed:

The po­ten­tial for re­gen­er­a­tive ther­a­pies in treat­ing a wide ar­ray of chron­ic de­gen­er­a­tive con­di­tions is well known. We see im­por­tant syn­er­gies for the on­col­o­gy field and the po­ten­tial to en­hance our fight against ma­lig­nant can­cers. Celu­lar­i­ty’s tech­nolo­gies, as­sets, and re­sources will help ad­vance se­lect­ed Sor­ren­to cel­lu­lar ther­a­py pro­grams and po­ten­tial­ly trans­form au­tol­o­gous cel­lu­lar ther­a­pies in­to af­ford­able and ac­ces­si­ble al­lo­gene­ic cell ther­a­pies.

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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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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Samantha Budd Haeberlein. Biogen via YouTube

UP­DAT­ED: Skep­tics pounce as Bio­gen de­tails pos­i­tive sub­group analy­sis on ad­u­canum­ab — and both sides are dig­ging in

“Exhilarating.” “A major advance.” “A milestone achievement.” If one had just tuned into the panel comments on Biogen’s presentation at CTAD, it would seem that the biotech had an impressive, disease-modifying Alzheimer’s drug in aducanumab.

But off the stage, reactions to their admittedly complicated dataset and the biotech’s explanation for resurrecting a drug that failed its futility analysis were a lot more mixed, with analysts continuing to question whether the evidence is substantial enough to warrant an FDA approval and raising new doubts on the safety side.

In an investor call later in the day, execs noted that they are not planning another study and stood by their intention, publicized in October to much surprise, to submit regulatory filings based on what they have.

“We don’t file willy nilly,” said Al Sandrock, head of R&D. “We only go to filing when we believe that there is a benefit-risk argument based on science, based on data. And if you look at our history, we haven’t done filings right and left without good reason.”

Biogen had a theory going into the Clinical Trials on Alzheimer’s Disease meeting.

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No­var­tis CEO Vas Narasimhan's R&D up­date spot­lights next wave of drug stars as well as late-stage fa­vorites

As one of the biggest spenders in biopharma R&D, Novartis execs love to tout the scope of its late-stage pipeline, spotlighting the winners most likely to create blockbuster revenue streams in the near future.

Building on the 5 drug approvals the pharma giant expects to end the year with, Novartis CEO Vas Narasimhan — who’s done a slate of acquisitions topped by the recent $9.7 billion MedCo buyout — tapped the top emerging drugs as:

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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.