FDA green­lights sec­ond Ebo­la treat­ment in three months, hand­ing new OK to Ridge­back­'s Eban­ga

A hus­band-and-wife biotech that li­censed a Covid-19 an­tivi­ral be­fore quick­ly part­ner­ing on it with Mer­ck ear­li­er this sum­mer has a new ap­proval in an­oth­er high­ly in­fec­tious dis­ease — Ebo­la.

Wendy Hol­man

Ridge­back Bio­ther­a­peu­tics, co-found­ed by CEO Wendy Hol­man and her hus­band Wayne Hol­man, a hedge fund man­ag­er who used to work for a com­pa­ny in­volved in one of the biggest in­sid­er trad­ing scan­dals in his­to­ry, has clinched an FDA OK for an­su­vimab-zykl to treat the dead­ly Ebo­la virus in adults and chil­dren. The drug, a mon­o­clon­al an­ti­body, will be mar­ket­ed as Eban­ga.

It’s the sec­ond-ever Ebo­la treat­ment to gain US ap­proval, both of which came over the last three months. Re­gen­eron’s an­ti­body cock­tail In­mazeb marked the first back in Oc­to­ber and was cho­sen by BAR­DA for the na­tion­al stock­pile in case of an out­break.

Both treat­ments were part of an NIH-spon­sored study in the De­mo­c­ra­t­ic Re­pub­lic of the Con­go dur­ing the coun­try’s 2018-19 out­break. Launched in Nov 2018, the study looked at four dif­fer­ent Ebo­la ther­a­pies and was stopped less than a year lat­er due to the over­whelm­ing­ly pos­i­tive re­sults pro­duced by Re­gen­eron and Ridge­back’s drugs.

The study it­self was ran­dom­ized and open-la­bel, with 174 pa­tients in the Eban­ga arm and 168 in the con­trol arm. Re­searchers honed in on 28-day mor­tal­i­ty rates as the pri­ma­ry end­point and found that, of those who re­ceived Eban­ga, 35.1% died af­ter 28 days. That fig­ure com­pared to 49.4% of those tak­ing the con­trol.

Reg­u­la­tors ad­vised against tak­ing both Eban­ga and an Ebo­la vac­cine at the same time. They not­ed that most of the com­mon side ef­fects from Eban­ga can al­so be con­fused with Ebo­la symp­toms them­selves, and rec­om­mend­ed dis­con­tin­u­a­tion should pa­tients de­vel­op a hy­per­sen­si­tiv­i­ty re­ac­tion.

Al­so in the study were a ZMapp an­ti­body and Gilead’s an­tivi­ral remde­sivir, which has since been re­pur­posed for Covid-19 and en­dorsed with a full FDA ap­proval de­spite lin­ger­ing ques­tions.

It’s been an event­ful year for the Mi­a­mi-based biotech. At the out­set of the Covid-19 pan­dem­ic in March, Hol­man struck a deal with Emory Uni­ver­si­ty to li­cense an ex­per­i­men­tal coro­n­avirus pill in­vent­ed by re­searchers there with $16 mil­lion in gov­ern­ment grants. Two months lat­er, Mer­ck gained world­wide rights to the pro­gram, dubbed EI­DD-2801, from Ridge­back for an undis­closed sum as part of their col­lab­o­ra­tion.

The quick turn­around drew con­cerns that Ridge­back at­tempt­ed to cash in big on a tax­pay­er-fund­ed pro­gram, with promi­nent Har­vard bioethi­cist Aaron Kessel­heim blast­ing the move in the Wash­ing­ton Post at the time. But in a Na­ture study pub­lished ear­li­er this month, re­sults showed that EI­DD-2801 com­plete­ly sup­pressed SARS-CoV-2 trans­mis­sion with­in 24 hours in fer­rets.

For Eban­ga, it’s not im­me­di­ate­ly clear where and how the drug will be used, giv­en Re­gen­eron’s pres­ence in the US strate­gic stock­pile and the DRC.

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.

Vlad Coric, Biohaven CEO

Vlad Coric charts course for 'New Bio­haven' with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the “New Biohaven” post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Robert Califf, FDA commissioner (via AP Images)

User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

Endpoints Premium

Premium subscription required

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