Agenus touts blockchain tech to roll out new ‘dig­i­tal se­cu­ri­ty’ for its PD-1, but will it work?

Be­set with set­backs, a once cash-poor Agenus had some­thing to cheer late last year when be­he­moth Gilead signed on as a part­ner on up to five of its im­muno-on­col­o­gy pro­grams. On Tues­day, the biotech of­fered in­vestors an in­trigu­ing pro­pos­al: fund the de­vel­op­ment of a sin­gle drug, while pre­serv­ing share­hold­er eq­ui­ty.

In per­haps the first in­stance of a bio­phar­ma com­pa­ny con­duct­ing such a ‘dig­i­tal se­cu­ri­ty’ of­fer­ing, Agenus said it was launch­ing a to­ken  de­signed to en­able qual­i­fied in­vestors to di­rect­ly in­vest in a sin­gle biotech prod­uct – in this case, the to­kens is­sued will rep­re­sent a por­tion of po­ten­tial fu­ture US sales of AGEN2034, Agenus’ late-stage an­ti-PD-1 an­ti­body.

Biren Amin

“I have nev­er seen this type of arrange­ment. I think there may be lim­i­ta­tions in terms of par­tic­i­pa­tion from in­sti­tu­tion­al in­vestors who may not be able to par­tic­i­pate,” Jef­feries’ Biren Amin, who cov­ers Agenus $AGEN, told End­points News.

The Agenus to­ken is pow­ered by blockchain tech­nol­o­gy, which was was in­vent­ed by an uniden­ti­fied de­vel­op­er in 2008 to pow­er Bit­coin, but is now used across a num­ber of ap­pli­ca­tions. Es­sen­tial­ly, it is a se­quence of blocks or groups of trans­ac­tions that are chained to­geth­er and dis­trib­uted among users, map­ping an un­al­ter­able record of trans­ac­tions that are not de­pen­dent on an ex­ter­nal au­thor­i­ty to val­i­date da­ta.

In­vestors will be el­i­gi­ble to pur­chase the Agenus’ to­kens un­der pre­ferred terms in the ini­tial stage of the of­fer­ing, which is slat­ed for mid-Feb­ru­ary. The Lex­ing­ton, MA-based com­pa­ny ex­pects to raise up to $100 mil­lion to de­vel­op and sell AGEN2034.

“Agenus an­tic­i­pates the in­dus­try will adopt this fi­nanc­ing mod­el as an at­trac­tive means of ob­tain­ing cap­i­tal in com­ing years. BEST (Agenus’ to­ken) is ex­pect­ed to lead to the emer­gence of a new mar­ket­place for as­set-spe­cif­ic se­cu­ri­ties pro­vid­ing in­vestors with unique fund­ing al­ter­na­tives and op­tions for man­ag­ing risk,” the can­cer drug de­vel­op­er said in a state­ment on Tues­day.

Brad Lon­car, chief ex­ec­u­tive of Lon­car In­vest­ments which runs the Lon­car Can­cer Im­munother­a­py ETF, sug­gest­ed a num­ber of peo­ple in the in­dus­try were work­ing on such fund­ing arrange­ments.

Brad Lon­car at the US-Chi­na Bio­phar­ma In­no­va­tion and In­vest­ment Sum­mit in Shang­hai on Oc­to­ber 23, 2018; End­points News, Pharm­Cube

Click on the im­age to see the full-sized ver­sion


“Set­ting aside the specifics of this Agenus PD-1, I do think the con­cept has po­ten­tial. It would al­low com­pa­nies to raise funds for sin­gle as­sets with­in their pipelines and for in­vestors to back in­di­vid­ual projects. It’s a very unique and ap­peal­ing con­cept.”

But the fresh ap­proach to fund­ing comes with fresh ques­tions. For in­stance, gov­er­nance. “These would all be in­di­vid­ual se­cu­ri­ties so how do you en­sure there is ap­pro­pri­ate in­vestor ed­u­ca­tion and trans­paren­cy through­out the drugs’ de­vel­op­ment?,” Lon­car said.

Then there is the ques­tion about liq­uid­i­ty. “These are like­ly to be small projects so it re­mains to be seen if these will be liq­uid as­sets that are priced ef­fi­cient­ly,” Lon­car not­ed, adding that if in­vestors elect to sell to­kens they will pre­sum­ably do so on the sec­ondary mar­ket like any oth­er to­ken.

There are a laun­dry list of oth­er hy­po­thet­i­cals to pon­der: since each to­ken will rep­re­sent a slice of fu­ture US sales of AGEN2034, what hap­pens if the drug is re­ject­ed? In con­trast, if the drug is ap­proved, what im­pact does this strat­e­gy have on any po­ten­tial part­ner­ships Agenus may want to ink in or­der to com­mer­cial­ize?

End­points has con­tact­ed Agenus for com­ment.

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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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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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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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.