Take­da hands TiGenix a rare, $434M mar­ket­ing deal for PhI­II stem cell ther­a­py

Bel­gian biotech TiGenix trig­gered a rare round of en­thu­si­asm for stem cell re­search a cou­ple of years back with news its lead off-the-shelf ther­a­py hit the pri­ma­ry end­point in a Phase III study treat­ing fis­tu­las in Crohn’s dis­ease pa­tients.  They backed it up a year lat­er with even more pos­i­tive da­ta. And now, a few months af­ter it was filed for ap­proval, Take­da is buy­ing its way in with a small deal to ac­quire the Eu­ro­pean rights to Cx601.

That good news made for an ex­cel­lent op­por­tu­ni­ty for TiGenix to si­mul­ta­ne­ous­ly re­treat from its per­son­al­ized car­ti­lage re­pair ther­a­py Chon­dro­C­elect, which nev­er gained mar­ket trac­tion.

TiGenix filed Cx601 for Eu­ro­pean ap­proval back in March, set­ting up the deal with Take­da that in­cludes a $27.5 mil­lion up­front, $16.5 mil­lion for an up­com­ing eq­ui­ty in­vest­ment and an­oth­er $390 mil­lion in mile­stones. The first of those mile­stones will be $11 mil­lion – pro­vid­ed Eu­ro­pean reg­u­la­tors ap­prove the ther­a­py.

Stem cell ther­a­pies have of­fered a se­ries of bit­ter set­backs over the years. Once seen as a nat­ur­al and promis­ing way to heal na­ture’s wounds, a slate of com­pa­nies tried and failed to de­vel­op new treat­ments with the tech. TiGenix claimed pi­o­neer­ing rights with the OK for Chon­dro­C­elect, its au­tol­o­gous (de­rived from pa­tient cells) ap­proach to knee dam­age. By the time the com­pa­ny filed for a $58 mil­lion IPO late last year, it bare­ly war­rant­ed a men­tion in the F-1.

Marc Prin­cen, Pres­i­dent of Take­da EU­Can

Cit­ing a tough reg­u­la­to­ry en­vi­ron­ment as well as the lack of re­im­burse­ment for its treat­ment, TiGenix said to­day it is be­gin­ning the process to with­draw the mar­ket­ing OK, end­ing a com­mer­cial­iza­tion deal it has in place with So­bi.

For Tigenix, the fu­ture will be all about al­lo­gene­ic (off the shelf) stem cell ther­a­pies.

“This col­lab­o­ra­tion and the ad­di­tion of Cx601 to our port­fo­lio high­lights Take­da’s com­mit­ment to the de­vel­op­ment of treat­ments to im­prove the health of peo­ple liv­ing with gas­troen­tero­log­i­cal dis­or­ders, lever­ag­ing our ex­per­tise in In­flam­ma­to­ry Bow­el Dis­ease and Crohn’s specif­i­cal­ly,” said Marc Prin­cen, pres­i­dent of Take­da in Eu­rope and Cana­da.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

A little more than a year ago, Flagship Pioneering rolled out a monster fund with $1.1 billion in it to bankroll the platform companies they were creating inside their own labs. But it turns out, that was just the prelude to a much, much larger raise, as both current investors — who’ve been reaping the rewards of some booming biotech stocks — join in with new investors betting on more in the years to come.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Geoffrey Porges, SVB Leerink

Top an­a­lyst maps a rocky road for Ver­tex — un­less they adopt a $10B M&A cam­paign to save the pipeline

After repeatedly poking Vertex $VRTX execs with pointed criticism of their R&D strategy, top SVB Leerink analyst Geoffrey Porges is now turning up the heat to a full-scale roasting.

In a note out early Monday morning, Porges spotlights the impact of Vertex’s recent follow-up failure on AATD — their treatment hit the endpoint but missed on commercial prospects — rewriting his recommended scenario for CEO Reshma Kewalramani as she grapples with the setback.

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Stephen Hahn (AP Images)

UP­DAT­ED: Ex-FDA com­mish Stephen Hahn joins Flag­ship, a ven­ture group that spawned Covid-19 vac­cine mak­er Mod­er­na

That revolving door between the FDA and industry is spinning even faster than usual.

Former FDA commissioner Stephen Hahn is joining Flagship Pioneering, the venture outfit that founded Moderna — which raced its way to an FDA EUA for a Covid-19 vaccine that is making billions of dollars– as the new CMO of its Preemptive Medicine and Health Security initiative.

Flagship confirmed the hire — first reported in The Washington Post — in a statement out late Monday.

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Patrizia Cavazzoni, CDER

FDA’s Cavaz­zoni calls for ad­comms to ‘get back to the sub­stance’

While her comments were recorded prior to the FDA’s recent approval of Biogen’s controversial Alzheimer’s drug, CDER Director Patrizia Cavazzoni presciently called for substantiating reforms to the advisory committee process at the agency.

Short on examples, Cavazzoni said at a BIO event aired on Monday that some recent adcomms show “how they can be swayed by emotion in the face of hard facts,” but they need to “get back to the fundamentals, which is listening to thoughtful input from experts in response to thoughtful questions that we ask them.”

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Terns Phar­ma­ceu­ti­cals touts safe­ty da­ta from an ex-Eli Lil­ly can­di­date in the hunt for NASH treat­ment

While many others have tried — and failed — to get a NASH candidate across the finish line, Terns Pharmaceuticals thinks its FXR agonist will eventually earn its wings without the safety issues that have slowed others down. Now, a mid-stage safety readout could help add some validity to those hopes.

No patients in the Phase IIa LIFT study discontinued TERN-101 due to side effects, CMO Erin Quirk said during a call with investors on Monday morning. That includes pruritus, an uncomfortable itching sensation that frequently leads patients to drop out of other FXR agonist studies.

Paul Burton, incoming Moderna CMO (J&J/file photo)

Look­ing be­yond the pan­dem­ic, Mod­er­na ap­points J&J vet­er­an Paul Bur­ton as new CMO

Moderna is turning to one of its Covid-19 vaccine competitors to fill its open CMO slot, but this time, it’s not the vaccine experience they’re after.

Paul Burton, who’s spent 16 years at J&J, most recently as chief global medical affairs officer of Janssen, will take over as Moderna CMO on July 6.

With an eye toward a future beyond the pandemic, the mRNA biotech went with Burton, who earned his MD and PhD degrees in London, as he offers experience on a range of therapeutic areas, as well as work as a cardiothoracic surgeon and leading tech projects with Apple.

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