Alzheon re­turns, with a $47M NIH grant and one last shot at a piv­otal PhI­II Alzheimer’s suc­cess

Alzheon has spent four years search­ing for in­vestors, pub­lic or pri­vate, will­ing to back a large study for their once-failed Alzheimer’s drug. On Thurs­day, they fi­nal­ly found a bene­fac­tor.

Mar­tin To­lar

The NIH’s In­sti­tute for Ag­ing award­ed Alzheon $47 mil­lion over the next five years for a piv­otal Phase III tri­al on their lead drug, ALZ-801. It’s not the IPO that CEO and founder Mar­tin To­lar want­ed — and twice filed for — but the com­pa­ny says it will be enough to start study they have want­ed to get off the ground for four years.

Alzheimer’s tri­als are no­to­ri­ous­ly long, dif­fi­cult to run and ex­pen­sive, but To­lar told End­points News in an email that the fund­ing would be enough to cov­er the full study. In its first IPO at­tempt, Alzheon had tried to raise up­wards of $100 mil­lion to launch two Phase III tri­als. The new raise is rough­ly in line with its sec­ond IPO at­tempt, when they said $40 mil­lion would be suf­fi­cient to start and get da­ta from a Phase IIb study.

The Phase III tri­al will en­roll 300 pa­tients and be­gin in the first quar­ter of 2021, the com­pa­ny said. In 2016, To­lar said they would need 500 peo­ple for the piv­otal stud­ies. On top of the new fil­ing, the com­pa­ny raised $6 mil­lion last year, ac­cord­ing to an SEC fil­ing.

Alzheon’s drug is built on the be­ta amy­loid hy­poth­e­sis — the one that, af­ter mul­ti­ple ma­jor fail­ures, seemed dead in the wa­ter be­fore Bio­gen an­nounced last year that a re-analy­sis of one of its Phase III tri­als showed their be­ta amy­loid drug ad­u­canum­ab was suc­cess­ful. A ver­sion of ALZ-801 has al­so failed once be­fore. Alzheon li­censed it from Neu­rochem (now known as Bel­lus Health) six years af­ter it failed in a Phase III study.

Re­bec­ca Edel­may­er

Re­bec­ca Edel­may­er, di­rec­tor of sci­en­tif­ic en­gage­ment at the Alzheimer’s As­so­ci­a­tion, ac­knowl­edged that treat­ments built around amy­loid hy­poth­e­sis have seen their share of set­backs, but she ar­gued that didn’t fore­close the pos­si­bil­i­ty for suc­cess with new med­i­cines with dif­fer­ent de­vel­op­ment and amy­loid-tar­get­ing strate­gies.

“That doesn’t mean all ap­proach­es to tar­get amy­loid are cre­at­ed the same,” Edel­may­er told End­points. “They don’t at­tack amy­loid in the same way, they don’t re­move amy­loid or pre­vent it from build­ing up in the same way. It’s im­por­tant we test all the ap­proach­es.”

Alzheon has ad­just­ed the mol­e­cule so it’s ab­sorbed more eas­i­ly in the blood. They say they can suc­ceed by giv­ing it to pa­tients ear­li­er — a com­mon re­frain among Alzheimer’s drug de­vel­op­ers — and by giv­ing it to the right pa­tients. The study will en­roll pa­tients with two APOE4 mu­ta­tions, putting them at a great­ly el­e­vat­ed risk of de­vel­op­ing amy­loid plaque buildup and Alzheimer’s it­self.

“This in­no­v­a­tive Phase 3 study is the first to ini­tial­ly fo­cus on symp­to­matic APOE4/4 pa­tients,” said An­ton Porsteins­son, a Uni­ver­si­ty of Rochester Alzheimer’s re­searcher who will serve as lead in­ves­ti­ga­tor. “If these bio­mark­ers cor­re­late with clin­i­cal ef­fi­ca­cy, this would en­able their use as po­ten­tial sur­ro­gate out­comes in Alzheimer’s pre­ven­tion tri­als, al­low­ing more ef­fi­cient tri­al de­sign.”

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

Endpoints editor and founder John Carroll sat down the Catalent CEO Alessandro Maselli to talk about what’s ahead in 2023. Right or wrong, this covers all the big issues faced by biopharma. This transcript has been edited for brevity and clarity.

John Carroll:

I think 2022 had to be one of the worst years ever for crystal balls. You went into 2022 thinking all sorts of nice things about what was ahead, not thinking about a European land war, maybe not thinking that the Federal Reserve was going to be jacking up interest rates as fast as they could to get ahead of inflation. Just a tremendous number of macroeconomic issues that were out there. The sudden and complete collapse of support on the markets in Nasdaq for biotech. A lot of darlings in the industry that had been out there for a while suddenly found themselves moving from a really hot market to a really cold market all of a sudden and had to make a lot of different changes in terms of strategizing.

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