Bris­tol-My­ers preps sec­ond check­point/can­cer vax com­bo study un­der its $1B Bavar­i­an Nordic pact

Paul Chap­lin, Bavar­i­an Nordic

Bris­tol-My­ers Squibb is ready to launch its sec­ond com­bi­na­tion tri­al us­ing Bavar­i­an Nordic’s can­cer vac­cine Prost­vac.

Op­er­at­ing un­der a 2015 deal worth up to about a bil­lion dol­lars, in­ves­ti­ga­tors will com­bine Prost­vac with Yer­voy and Op­di­vo in 10 pa­tients with cas­tra­tion-re­sis­tant prostate can­cer. Then they’ll push en­roll­ment to 55 and divvy up the pa­tients in­to three co­horts, study­ing T cell in­fil­tra­tion in tu­mors with one-on-one com­bos or the triple.

The first tri­al in the part­ner­ship was be­gun last fall, test­ing a com­bi­na­tion of Prost­vac and Yer­voy in ear­ly prostate can­cer.

The the­o­ry here is sim­ple enough. Bris­tol-My­ers check­point drugs are de­signed to take the brakes off an im­mune sys­tem at­tack on can­cer cells while Prost­vac is de­signed to hit the gas. Can­cer vac­cines have proven to be large­ly too mild to gen­er­ate much of a clin­i­cal re­sponse in pa­tients, but re­searchers have the­o­rized that an en­hanced at­tack with check­point drugs could pro­vide a sig­nif­i­cant ben­e­fit.

The step for­ward in the pact is a plus for Bavar­i­an Nordic, which had to scrap plans for an IPO while fend­ing off an open short at­tack by Ker­ris­dale Cap­i­tal, which ridiculed Prost­vac and claimed that the Phase II da­ta it had tout­ed was large­ly an il­lu­sion due to a strik­ing­ly bad place­bo re­sponse.

We’ll know more lat­er this year when Bavar­i­an Nordic re­leas­es top-line da­ta from its Phase III prostate can­cer study.

The move al­so un­der­scores that Bris­tol-My­ers’ com­mit­ment to its check­point pro­gram, led by the CT­LA-4 and PD-1 drugs, re­mains as strong as ever as the com­pa­ny looks to get its groove back fol­low­ing a bit­ter set­back on non-small cell lung can­cer, which saw its ri­vals at Mer­ck leapfrog ahead with Keytru­da.

All the key check­point play­ers, in­clud­ing Genen­tech and Pfiz­er/Mer­ck KGaA, have been bar­rel­ing ahead with hun­dreds of com­bi­na­tion stud­ies, look­ing to grab the lead in var­i­ous niche can­cer mar­kets. That’s a multi­bil­lion-dol­lar op­por­tu­ni­ty no one wants to lose.

“There are now eleven on­go­ing stud­ies of Prost­vac across var­i­ous stages of prostate can­cer. In re­cent years, there has been a grow­ing in­ter­est in the eval­u­a­tion of the im­munother­a­py can­di­date in ear­li­er dis­ease stages, where the can­cer has not yet spread be­yond the prostate. We are ex­cit­ed to learn more about the po­ten­tial of Prost­vac for treat­ing this pop­u­la­tion, and to eval­u­ate the po­ten­tial syn­er­gis­tic ef­fects of com­bin­ing the vac­cine with check­point in­hibitors, as we be­lieve Prost­vac may en­hance the clin­i­cal ac­tiv­i­ty of these drugs,” said Paul Chap­lin, Pres­i­dent & Chief Ex­ec­u­tive Of­fi­cer of Bavar­i­an Nordic.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.