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

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“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.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.

Luciana Borio (Susan Walsh/AP Images)

UP­DAT­ED: Bob Nelsen's ARCH adds FDA, biode­fense ex­per­tise with ap­point­ment of Lu­ciana Bo­rio

Once vetted by the Biden team to lead the FDA as commissioner, Luciana Borio is now compiling quite the résumé.

Borio has now been named a venture partner at Bob Nelsen’s ARCH Venture Partners, and Nelsen told Endpoints News, “She will be involved in projects across the portfolio, including ongoing projects in manufacturing, clinical trials, gene therapy and gene editing, cell therapy, and delivery. We are exploring multiple projects in infectious disease, and next generation manufacturing.”