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.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.

Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.