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.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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