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. 

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Rep. Vern Buchanan (R-FL) (Bill Clark/CQ Roll Call via AP Images)

Af­ter cov­er­age re­stric­tions for Alzheimer's drugs, bi­par­ti­san House bill would force CMS to re­view drugs in­di­vid­u­al­ly

When Biogen’s controversial Alzheimer’s drug Aduhelm was hit with a national decision from CMS that restricted coverage to only randomized trials, practically guaranteeing a commercial flop in the near term, questions surfaced over why CMS also included all amyloid-targeted monoclonal antibodies for Alzheimer’s disease.

With Eisai and Biogen’s second Alzheimer’s drug, lecanemab, now showing it can slow the rate of cognitive decline versus placebo, lining up for a likely full approval next spring, the question now turns to whether that data, which is being presented at the Clinical Trials on Alzheimer’s Congress in San Francisco in late November, will be enough for CMS when it asks, “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”

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FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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Af­ter Covid set­back, Val­ne­va lines up $100M for Pfiz­er-al­lied Ly­me dis­ease PhI­II

Valneva has secured €102.9 million (around $99.9 million USD) in a share offering to push forward its Pfizer-partnered Lyme disease vaccine and a jab for chikungunya that awaits an FDA decision.

The French vaccine maker largely snagged the near $100 million from Deep Track Capital and local state-owned Bpifrance, the company said Tuesday night. The capital injection is nearly equal to the amount Pfizer paid to nab equity in the company earlier this summer as part of the duo’s vaccine tie-up.