Ker­ris­dale 2-0 this week: Bavar­i­an Nordic's can­cer vac­cine is a bust in PhI­II

An­oth­er can­cer vac­cine has bit­ten the dust.

Six long years af­ter start­ing their Phase III tri­al for the prostate can­cer vac­cine Prost­vac, an in­de­pen­dent mon­i­tor­ing com­mit­tee says it’s time to sim­ply scrap Bavar­i­an Nordic’s {$BA­VA.CO} study af­ter con­clud­ing it wasn’t work­ing at a fi­nal in­ter­im analy­sis stage.

In­vestors who had stuck with the Dan­ish biotech weren’t pleased. Its shares lost half their val­ue, and one an­a­lyst, Pe­ter Welford at Jef­feries, says the flop could read through to a fol­low up pro­gram. He wrote:

We note BA­VA al­so has CV-301 in Phase II for blad­der can­cer and en­ter­ing Phase Ib/II for lung can­cer (NSCLC) +Keytru­da, plus Phase II for urothe­lial car­ci­no­ma +Tecen­triq. CV-301 com­pris­es a sim­i­lar back­bone and TRI­COM co-stim­u­la­to­ry mol­e­cules to PROST­VAC with dif­fer­ent anti­gens. Hence, giv­en the sig­nif­i­cant set­back for PROST­VAC, we ex­pect the mar­ket to now more heav­i­ly dis­count CV-301, with our NPV c.DKK30/share (9%).

Paul Chap­lin, Bavar­i­an Nordic

Bris­tol-My­ers Squibb paid $60 mil­lion up front to li­cense the can­cer vac­cine, with $80 mil­lion lined up for the op­tion on Phase III da­ta, with hun­dreds of mil­lions in prospec­tive mile­stones.

That all just went poof.

The late-stage fail­ure fol­lows a short at­tack from Sahm Ad­ran­gi’s Ker­ris­dale Cap­i­tal, who called it two years ago as a se­ries of can­cer vac­cines like Stimu­vax fell short of the mark.

“The his­to­ry of ther­a­peu­tic can­cer vac­cines is two decades of un­mit­i­gat­ed fail­ure,” Ad­ran­gi wrote in 2015. “We ex­pect noth­ing dif­fer­ent from Bavar­i­an Nordic.”

The set­back al­so fol­lows mul­ti­ple de­lays, which Chap­lin had cheered as an in­di­ca­tion that tak­ing more time to reach the num­ber of events need­ed for the read­out was an in­di­ca­tion of suc­cess.

That the­o­ry, which has been used by North­west Bio and oth­ers, has been proven wrong time and again.

Ker­ris­dale Cap­i­tal has been proven right twice this week, with Sage’s ug­ly mis­fire on SRSE prov­ing that the drug was no bet­ter than a place­bo in get­ting a re­sponse. But in that case, be­ing right didn’t mean win­ning a cash re­ward, as Sage’s stock went up af­ter the Phase III fail­ure.

As far as the stock mar­ket is con­cerned now, these are spe­cial times, when in­vestor re­ac­tions can be marked­ly dif­fer­ent than the norm.

I asked Ad­ran­gi what he thought about the fail­ure. His re­sponse:

“Prost­vac’s fail­ure is what any ob­serv­er should have ex­pect­ed giv­en the un­ex­cep­tion­al ear­li­er stage treat­ment arm sur­vival. The vac­cine’s un­so­phis­ti­cat­ed de­sign was doomed for fail­ure — sim­ply ad­min­is­ter­ing tu­mor-as­so­ci­at­ed anti­gens and hop­ing for an ef­fec­tive im­mune re­sponse al­ways seemed to us a dead end.”
“We are ex­treme­ly dis­ap­point­ed for pa­tients that this study of Prost­vac as monother­a­py was not suc­cess­ful,” said Bavar­i­an Nordic CEO Paul Chap­lin. “While this is cer­tain­ly not the de­sired out­come, we re­main stead­fast be­liev­ers in the pow­er of com­bi­na­tion treat­ments, in­clud­ing im­munother­a­pies, to trans­form the fu­ture of can­cer ther­a­pies.”

J&J team shows off 'break­through' BC­MA CAR-T da­ta, and it's every bit as good as they had ex­pect­ed

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 the multiple myeloma data for JNJ-4528 that impressed the FDA.

Following up on some attention-grabbing data initially presented by their Chinese development partners at Legend 2 years ago during ASCO, investigators say they tracked some jaw-dropping results that confirmed the early promise of a therapy that’s shaking up a crowded field led by bluebird bio.

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

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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.