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.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.