World Health Organization Director-General Tedros Adhanom Ghebreyesus attends a press conference following an emergency committee meeting over Ebola epidemic in Democratic Republic of Congo at the WHO headquarters in Geneva on October 18, 2019. (via Getty Images)

As Con­go Ebo­la out­break fes­ters, FDA ap­proves first vac­cine to com­bat dead­ly virus

As an Ebo­la out­break rages on in the De­mo­c­ra­t­ic Re­pub­lic of Con­go — the FDA has ap­proved the first vac­cine to pro­tect against the dead­ly he­m­or­rhag­ic virus, months ear­li­er than ex­pect­ed. Man­u­fac­tured by Mer­ck the de­vel­op­ment of the vac­cine, chris­tened Erve­bo, be­gan dur­ing the West African out­break that oc­curred be­tween 2014 and 2016, which killed more than 11,000.

The ap­proval for the ge­net­i­cal­ly en­gi­neered at­ten­u­at­ed live vac­cine comes about five weeks af­ter its Eu­ro­pean en­dorse­ment. Mer­ck ex­pects to launch the vac­cine in the third quar­ter of 2020.

“We have not yet es­tab­lished a price for ERVE­BO. Mer­ck has com­mit­ted to mak­ing the vac­cine avail­able to Gavi (the Vac­cine Al­liance)-el­i­gi­ble coun­tries at the low­est pos­si­ble ac­cess price,” a com­pa­ny spokesper­son told End­points News.

Erve­bo has been test­ed in rough­ly 16,000 in­di­vid­u­als aged 18 and above in tri­als con­duct­ed in Africa, Eu­rope, and the Unit­ed States, and da­ta show the vac­cine is ef­fec­tive against the Zaire Ebo­la virus that cir­cu­lat­ed in West Africa in 2014-2016, as well as the cur­rent out­break in DRC.

In the Guinea tri­al, 3,537 con­tacts, and con­tacts of con­tacts, of in­di­vid­u­als with lab­o­ra­to­ry-con­firmed Ebo­la virus dis­ease re­ceived ei­ther “im­me­di­ate” or 21-day “de­layed” vac­ci­na­tion with Erve­bo. Some 2,108 in­di­vid­u­als were in the “im­me­di­ate” vac­ci­na­tion arm and 1,429 were in the “de­layed” vac­ci­na­tion group, and the re­sults show that Erve­bo was found to be 100% ef­fec­tive in pre­vent­ing Ebo­la cas­es with symp­tom on­set greater than 10 days af­ter vac­ci­na­tion. No Ebo­la cas­es with symp­tom on­set greater than 10 days af­ter vac­ci­na­tion were ob­served in the im­me­di­ate clus­ter group, com­pared with 10 such Ebo­la cas­es in the 21-day de­layed clus­ter group.

An­ti­body re­spons­es to Erve­bo were as­sessed in 477 in­di­vid­u­als in Liberia, rough­ly 500 in Sier­ra Leone and about 900 in­di­vid­u­als in Cana­daSpain, and the Unit­ed States — across ge­og­ra­phy, the an­ti­body re­spons­es were sim­i­lar.

Ebo­la is thought to have in­fil­trat­ed the hu­man pop­u­la­tion through close con­tact with the blood, se­cre­tions, or­gans or oth­er bod­i­ly flu­ids of in­fect­ed an­i­mals such as fruit bats, chim­panzees, go­ril­las, mon­keys, for­est an­te­lope or por­cu­pines. Even­tu­al­ly, it spread be­tween hu­mans through di­rect con­tact, via the blood or bod­i­ly flu­ids of an in­fect­ed per­son.

The cur­rent out­break in the De­mo­c­ra­t­ic Re­pub­lic of Con­go has shown case fa­tal­i­ty rates of more than 65%, the WHO has es­ti­mat­ed. Al­though there has been a re­cent spike in in­fec­tions, the cur­rent in­fec­tion rates are well be­low the 120 cas­es a week re­port­ed dur­ing the peak of the out­break in late April. On Thurs­day, the WHO said it had record­ed the first Ebo­la re­lapse in the cur­rent epi­dem­ic.

Ear­li­er this year the WHO de­clared the out­break — which so far has in­fect­ed more than 3,350 peo­ple — a pub­lic health emer­gency of in­ter­na­tion­al con­cern. As of De­cem­ber 17, over a quar­ter of all con­firmed Ebo­la cas­es in the DRC have been in chil­dren aged less than 18 years. A Mer­ck spokesper­son said the com­pa­ny has stud­ies un­der­way test­ing Erve­bo (same for­mu­la­tion, same dose) in chil­dren.

The vac­cine was ini­tial­ly en­gi­neered by sci­en­tists from the Pub­lic Health Agency of Cana­da’s Na­tion­al Mi­cro­bi­ol­o­gy Lab­o­ra­to­ry and sub­se­quent­ly li­censed to a unit of NewLink Ge­net­ics Corp. In 2014, as the virus wreaked hav­oc in West Africa, Mer­ck ac­quired the tech­nol­o­gy from NewLink (Bat­tered by a se­ries of set­backs, Newlink in Oc­to­ber be­came the ve­hi­cle for a re­verse merg­er).

In re­sponse to re­quests from the WHO, since May 2018, the large US drug­mak­er has do­nat­ed 275,000 dos­es of the vac­cine to com­bat the out­break in the DRC. With the FDA ap­proval, Mer­ck has al­so qual­i­fied for a trop­i­cal dis­ease pri­or­i­ty re­view vouch­er (PRV) — these vouch­ers, used to has­ten drug re­views, have been sold in the past for mil­lions, rang­ing from $95 mil­lion to even $350 mil­lion.

The rel­a­tive­ly few Ebo­la cas­es in the Unit­ed States have been due to in­ter­na­tion­al trav­el­ers or health care work­ers who have con­tract­ed the virus af­ter treat­ing Ebo­la pa­tients.

“While the risk of Ebo­la virus dis­ease in the U.S. re­mains low, the U.S. gov­ern­ment re­mains deeply com­mit­ted to fight­ing dev­as­tat­ing Ebo­la out­breaks in Africa, in­clud­ing the cur­rent out­break in the De­mo­c­ra­t­ic Re­pub­lic of the Con­go,” said An­na Abram, FDA Deputy Com­mis­sion­er for Pol­i­cy, Leg­is­la­tion, and In­ter­na­tion­al Af­fairs, in a state­ment.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.