Greg Mayes, Antios CEO

An­tios Ther­a­peu­tic­s' hep B can­di­date gets an­oth­er round of ap­plause from in­vestors, clos­ing out a $171M megaround

An­tios Ther­a­peu­tics, the At­lanta biotech that was the brain­child of for­mer hep C pi­o­neer Phar­mas­set ex­ec­u­tive and for­mer An­tios CEO Abel De La Rosa, an­nounced this morn­ing that the biotech raised $75 mil­lion in a Se­ries B-1, end­ing the firm’s Se­ries B round.

Af­ter the biotech threw its hat in­to the he­pati­tis B ring three years ago with $25 mil­lion from a Se­ries A, An­tios then raised $96 mil­lion from a Se­ries B in April to push their lead can­di­date — an ac­tive site poly­merase in­hibitor nu­cleotide, or AS­PIN known as ATI-2173 — through Phase II. The lat­est $75 mil­lion round brings the com­pa­ny’s Se­ries B up to $171 mil­lion.

This fi­nanc­ing round, co-led by young in­vest­ment firm Gor­don­MD Glob­al In­vest­ments, will help push An­tios’ lead can­di­date — in test­ing by it­self and with teno­fovir — to a Phase IIb tri­al to start next year. Oth­er in­vestors in­clud­ed RA Cap­i­tal, LifeSci Ven­ture Part­ners and Lu­mi­ra Ven­tures.

Back in April, ATI-2173 was in a Phase IIa study in com­bi­na­tion with ap­proved HBV an­tivi­ral teno­fovir. And ac­cord­ing to An­tios CEO Greg Mayes, the Phase IIb tri­al will start some­time in the sec­ond half of 2022.

“We would ex­pect to com­plete the Phase IIb pro­gram in 2024,” Mayes told End­points News.

An­tios’ can­di­date is de­rived from an old Phar­mas­set drug called cle­vu­dine — which start­ed out at Buk­wang Phar­ma­ceu­ti­cals be­fore be­ing li­censed to Tri­an­gle in 1998. Af­ter buy­ing out Tri­an­gle in 2003, Gilead trans­ferred the rights back to Buk­wang, which then li­censed the drug to Phar­mas­set in 2005.

“We are pleased to add Gor­don­MD Glob­al In­vest­ments to our ex­ist­ing group of high-cal­iber health­care in­vestors,” Mayes said in a pre­pared state­ment. “This round of in­vest­ment en­ables us to ac­cel­er­ate the Phase IIb clin­i­cal de­vel­op­ment of ATI-2173.”

In their press re­lease, An­tios al­so an­nounced that Gor­don­MD’s founder and CEO Craig Gor­don will join An­tios’ board of di­rec­tors.

“We be­lieve in the mis­sion that An­tios’ man­age­ment and clin­i­cal teams are dri­ving for­ward and are ex­cit­ed to be a part of their next phase of growth,” said Gor­don­MD founder and CEO Craig Gor­don in a state­ment.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.