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.

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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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Steve Harr, Sana Biotechnology CEO

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Sana Biotechnology is finally headed to the clinic.

Thursday afternoon, the biotech announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf,” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias. Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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