David Hering, Adagio interim CEO

Ada­gio press­es for­ward with their FDA pitch for Covid an­ti­body — de­spite Omi­cron flaws

Ada­gio, the Till­man Gern­gross biotech whose $750 mil­lion plan to build a pan-coro­n­avirus an­ti­body seem­ing­ly fell apart in the face of Omi­cron, is back again plead­ing its case.

The com­pa­ny re­leased da­ta from its piv­otal tri­als Wednes­day, an­nounc­ing that its an­ti­body ad­in­tre­vimab re­duced the risk of hos­pi­tal­iza­tion or death in par­tic­i­pants with mild to mod­er­ate Covid-19 by 66%, in­clud­ing a 77% re­duc­tion in pa­tients who were treat­ed with­in 3 days of symp­tom on­set.

The drug al­so worked as pre-ex­po­sure and post-ex­po­sure pro­phy­lax­is, re­duc­ing the risk of vol­un­teers de­vel­op­ing symp­to­matic Covid-19 by 71% and 75% re­spec­tive­ly.

The prob­lem is that near­ly all of the da­ta for the study were col­lect­ed pri­or to the ad­vent of Omi­cron, a vari­ant that Ada­gio’s own da­ta showed re­duced the po­ten­cy of their an­ti­body 300 times, forc­ing the com­pa­ny to pur­sue al­ter­na­tive strate­gies such as chang­ing dose and com­bi­na­tion treat­ments.

De­spite the set­backs, the biotech con­tin­ued to in­sist that the an­ti­body was al­ready so po­tent that it might have ef­fi­ca­cy against Omi­cron, even if it was re­duced. Lim­it­ed da­ta col­lect­ed in the tri­als at­test­ed to that. For ex­am­ple, pa­tients who re­ceived pro­phy­lac­tic ad­in­tre­vimab were still 47% less like­ly to de­vel­op symp­to­matic dis­ease with­in 77 days fol­low­ing the emer­gence of Omi­cron. (Ada­gio did not spec­i­fy when they be­gan the analy­sis or how wide­spread Omi­cron was at the time.)

But the US is no longer deal­ing sole­ly with Omi­cron. Omi­cron’s “sis­ter vari­ant,” BA.2, is now caus­ing a ma­jor­i­ty of new cas­es na­tion­wide, ac­cord­ing to CDC da­ta.

And Ada­gio’s drug has vir­tu­al­ly ze­ro ac­tiv­i­ty against BA.2, analy­ses from out­side labs have demon­strat­ed.

Nev­er­the­less, the com­pa­ny is go­ing to press its case at the FDA, with plans to sub­mit an ap­pli­ca­tion for emer­gency use au­tho­riza­tion in Q2. The com­pa­ny’s state­ment did not ad­dress the drug’s dra­mat­i­cal­ly re­duced ef­fi­ca­cy against BA.2.

Ada­gio al­so said it’s con­tin­u­ing with tri­als on a high­er dose of ad­in­tre­vimab while de­vel­op­ing new an­ti­bod­ies from its li­brary and at­tempt­ing to re-en­gi­neer ad­in­tre­vimab to have im­proved bind­ing against the new vari­ants.

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.

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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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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No longer ‘dead or just hi­ber­nat­ing,’ drug­mak­ers re­turn to heart med­i­cines

In 2015, now-FDA Commissioner Robert Califf joined industry, academic and regulatory representatives in Washington to discuss why more drugs weren’t in development for cardiovascular diseases, the leading US cause of death and once a mainstay of pharmaceutical industry blockbusters.

The group pointed to many reasons. Clinical trials could take years and testing was expensive. Wide availability of generic drugs made the commercial prospects uncertain. Their paper title summed up the mood: “Cardiovascular Drug Development: Is it Dead or Just Hibernating?”

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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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Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.