CEO Greg Mayes (Antios)

The hunt for a hep B cure heats up, as An­tios Ther­a­peu­tics preps for an IPO

While he­pati­tis B virus (HBV) in­fec­tion is avoid­able with a vac­cine, a host of com­pa­nies are search­ing for a cure for the hun­dreds of thou­sands in the US who al­ready have it. An­tios Ther­a­peu­tics threw its hat in the ring three years ago, and on Mon­day closed a $96 mil­lion crossover round to see its lead pro­gram through Phase II.

When asked if an IPO is on the hori­zon, CEO Greg Mayes said: “We’re go­ing to be pre­pared for one, yes.”

Doug May­ers

An­tios launched back in 2018 with $25 mil­lion in Se­ries A fund­ing and a goal to form the “back­bone” of a cu­ra­tive reg­i­men for chron­ic HBV. It was found­ed by Abel De La Rosa, a for­mer ex­ec­u­tive at hep C pi­o­neer Phar­mas­set, and CMO Doug May­ers, who hailed from Idenix. Mayes took the helm back in De­cem­ber af­ter De La Rosa re­tired.

When it comes to tack­ling HBV, May­ers says there are two “philo­soph­i­cal camps.” One is to boost im­mu­ni­ty us­ing vac­ci­na­tions, TLR in­hibitors or siR­NAs. The sec­ond is to shut the virus down com­plete­ly so the nor­mal im­mune sys­tem can clear it out. An­tios is part of the lat­ter.

The com­pa­ny’s lead can­di­date, dubbed ANT-2173, is an ac­tive site poly­merase in­hibitor nu­cleotide (AS­PIN) de­rived from an old Phar­mas­set drug called cle­vu­dine. While cur­rent­ly ap­proved treat­ments, like teno­fovir and en­te­cavir, con­trol vi­ral repli­ca­tion, the ef­fect quick­ly wanes af­ter treat­ment is stopped. An­tios’s ap­proach is to in­hib­it vi­ral repli­ca­tion one poly­merase at a time, ver­sus one genome at a time, po­ten­tial­ly giv­ing pa­tients the abil­i­ty to safe­ly with­draw treat­ment.

ANT-2173 had “po­tent on-treat­ment and durable off-treat­ment ef­fects” as a monother­a­py in a Phase Ib study, ac­cord­ing to An­tios. Mayes said the com­pa­ny will pro­vide more de­tailed re­sults in June. The can­di­date is cur­rent­ly in a Phase IIa study in com­bi­na­tion with teno­fovir, and is ex­pect­ed to en­ter Phase IIb by mid-2022.

“The three arms that we’re cur­rent­ly do­ing will be com­plet­ed this year,” May­ers said of the Phase IIa. “We could con­tin­ue adding arms to that study to ex­plore nov­el mech­a­nisms or nov­el strate­gies. So I’m not sure that it’s go­ing to end any­time soon. It may be­come our de­vel­op­ment plat­form for the com­pa­ny to ex­plore com­bi­na­tions with oth­er com­pa­nies.”

Cle­vu­dine start­ed out at Buk­wang, be­fore it was li­censed to Tri­an­gle Phar­ma­ceu­ti­cals in 1998. Af­ter buy­ing out Tri­an­gle in 2003, Gilead trans­ferred the rights back to Buk­wang, which then li­censed the can­di­date to Phar­mas­set two years lat­er.

Phar­mas­set end­ed up dis­con­tin­u­ing the pro­gram af­ter 1% of pa­tients in a Phase III tri­al de­vel­oped re­versible prox­i­mal skele­tal mus­cle my­opa­thy at the one-year mark.

An­tios says ANT-2173 should avoid those ef­fects be­cause it’s tar­get­ed to the liv­er. With the orig­i­nal for­mu­la­tion, there was a “bo­lus of cle­vu­dine” that the kid­neys would have to clear out, May­ers said.

“With our drug it’s very slow­ly re­leased from the liv­er over 24 hours, the kid­neys han­dle it much more ef­fi­cient­ly, so we’re drop­ping the ex­po­sure to cle­vu­dine very sig­nif­i­cant­ly, and so we get more po­ten­cy, much low­er cle­vu­dine ex­po­sure is in the blood, and we think that by lim­it­ing our treat­ment to one year… we should drop the risk of my­opa­thy well be­low the 1% that was orig­i­nal­ly seen,” he said.

An­tios is up against a host of com­pa­nies hunt­ing for an HBV cure, in­clud­ing Vir Biotech­nol­o­gy, which read out Phase I da­ta back in Jan­u­ary that were so promis­ing they even sur­prised the CMO. As­sem­bly Bio­sciences’ at­tempt flopped in a Phase II tri­al in No­vem­ber. In Au­gust, Glax­o­SmithK­line show­cased the proof-of-con­cept da­ta that con­vinced it to ex­er­cise the op­tion on Io­n­is’ he­pati­tis B treat­ments. But J&J and Ar­row­head are rush­ing to beat it, as well as Roche, which signed up to de­vel­op Dicer­na’s drug.

Cor­rec­tion: A pre­vi­ous ver­sion of this sto­ry in­cor­rect­ly stat­ed that An­tios launched in 2015. The cor­rect year is 2018. 

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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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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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.

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.

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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#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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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

Al­to Neu­ro­science bags $25M for four Phase II drugs

Another $25 million is flowing the way of a California biotech attempting to fix the “trial and error” system in neuroscience drug R&D.

Alto Neuroscience picked up the capital from Alpha Wave Ventures via an extension to its Series B, bringing total equity raised to $100 million since the startup’s 2019 founding. The biotech also recently signed up for a $35 million credit facility.

All that capital will help the biotech investigate four drugs through four Phase II readouts, Alto said Monday morning. That means enough money to keep the lights on into 2025, a year longer than projected under the original Series B close.

Tyler Golato, VitaDAO co-initiator

Pfiz­er-backed de­cen­tral­ized co­op­er­a­tive rais­es $4.1M to fund longevi­ty re­search

Months after Pfizer Ventures put a decentralized cooperative on the map by announcing a $500,000 infusion into its mission of funding human longevity research, the group — VitaDAO — is tying the bow around a $4.1 million fundraising round.

As its name implies, VitaDAO calls itself a DAO, or decentralized autonomous organization. Like many other such groups, it aims to run on a relatively flat, global structure using contracts on blockchains and crypto-tied tokens in hopes of proving a new way to fund big ideas and bridge the valley of death for very early-stage research on anti-aging.