Re­gen­eron to seek EUA for low­er dose of Covid-19 mAb cock­tail as new tri­al shows ma­jor drop in risk of hos­pi­tal­iza­tion or death

The suc­cess of mon­o­clon­al an­ti­body (mAb) cock­tails in keep­ing peo­ple with Covid-19 out of the hos­pi­tal con­tin­ued Tues­day, with Re­gen­eron an­nounc­ing that even a low­er-than-au­tho­rized dose of its com­bi­na­tion of mAbs re­duced hos­pi­tal­iza­tion or death by 70% in non-hos­pi­tal­ized Covid-19 pa­tients.

George Yan­copou­los

“We will rapid­ly dis­cuss the new da­ta with reg­u­la­to­ry au­thor­i­ties and re­quest that the 1,200 mg dose be added to the U.S. Emer­gency Use Au­tho­riza­tion, in or­der for the an­tic­i­pat­ed RE­GEN-COV sup­ply to be avail­able to treat even more pa­tients,” George Yan­copou­los, pres­i­dent and CSO of Re­gen­eron, said in a state­ment.

The place­bo-con­trolled tri­al of more than 4,500 peo­ple showed how casiriv­imab and imde­vimab re­duced the risk of hos­pi­tal­iza­tion or death by 70% for the 1,200 mg IV dose, and 71% for the au­tho­rized 2,400 mg IV ver­sion, when com­pared to place­bo, the com­pa­ny said.

In ad­di­tion, Re­gen­eron said a dose-rang­ing Phase II tri­al of 815 non-hos­pi­tal­ized Covid-19 pa­tients showed “sig­nif­i­cant and com­pa­ra­ble vi­ral re­duc­tions” for all dos­es test­ed of the mAb com­bo, in­clud­ing as low as 300 mg. A com­pa­ny spokesper­son said fur­ther dis­cus­sions with the FDA will be nec­es­sary to dis­cuss sub­cu­ta­neous ad­min­is­tra­tion, and “even low­er dose pos­si­bil­i­ties in the fu­ture.”

Walid Gel­lad

Walid Gel­lad, di­rec­tor of the Uni­ver­si­ty of Pitts­burgh Cen­ter for Phar­ma­ceu­ti­cal Pol­i­cy and Pre­scrib­ing, who’s un­af­fil­i­at­ed with the re­sults, said that they show yet an­oth­er ex­am­ple of how ef­fec­tive these mAbs are for out­pa­tient use to re­duce hos­pi­tal­iza­tion.

“Com­pa­nies in a pan­dem­ic should be ap­plaud­ed for test­ing low­er dos­es, which will ex­tend sup­ply,” he added.

De­spite the pos­i­tive new da­ta, dos­es of the Re­gen­eron and Eli Lil­ly mAb cock­tails have been dif­fi­cult to come by and states have had to grap­ple with fig­ur­ing out new ways to ad­min­is­ter the in­fu­sions.

A Re­gen­eron spokesper­son said the com­pa­ny so far has de­liv­ered near­ly 300,000 dos­es to the US (al­though the gov­ern­ment’s web­site still says it’s dis­trib­uted about 150,000 as of ear­ly Feb­ru­ary). Be­gin­ning in April, Re­gen­eron will de­liv­er sup­plies of the mAb cock­tail un­der its sec­ond con­tract with the US gov­ern­ment, which will pro­vide 750,000 or more dos­es by mid-year.

“Most re­cent­ly we have said we ex­pect to pro­vide ap­prox­i­mate­ly 750,000 dos­es at the 2,400 mg dose lev­el by June 30, but now we an­tic­i­pate be­ing able to pro­vide more if the 1,200 mg dose is added to the EUA,” the spokesper­son added.

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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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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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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