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. 

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Daisy Robinton, Oviva Therapeutics co-founder and CEO

A new spin­out wades in­to ovar­i­an ag­ing, armed with a seed round and ex­per­i­men­tal drugs from Mass Gen­er­al

There aren’t many biotechs emphasizing women’s health, but a new spinout is trying to change that.

Oviva Therapeutics, a pipeline company of New York-based Cambrian Biopharma, emerged from stealth earlier this week to dive into the idea of extending women’s “healthspans,” or what it says is the part of a person’s life spent in generally good health, with a specific focus on ovaries. The emergence comes both with a seed financing worth $11.5 million from Cambrian, and an in-licensing agreement with Massachusetts General Hospital for a trio of patents.

Castle Creek Biosciences chair Jeff Aronin

Scoop: Af­ter pulling IPO am­bi­tions last De­cem­ber, Jeff Aron­in's Cas­tle Creek turns to pri­vate back­ers

Jeff Aronin’s cell and gene therapy biotech Castle Creek Biosciences has raised $112 million in equity, Endpoints News has learned.

The Exton, PA, biotech secured the financing from 54 investors, according to an SEC filing dated May 2. The late-stage startup had last year considered a $100 million Nasdaq debut, but in a sign of the bear market that has plagued hundreds of newly minted public biotechs, Castle Creek pulled those ambitions in the last few weeks of 2021.

Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.