Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Ama­zon joins Fred Hutch on clin­i­cal tri­al for per­son­al­ized can­cer vac­cine — re­port

Ama­zon is part­ner­ing with the Fred Hutchin­son Can­cer Re­search Cen­ter on a Phase I tri­al for a can­cer vac­cine tar­get­ing metasta­t­ic melanoma and breast can­cer.

The clin­i­cal tri­al is part of Ama­zon’s Grand Chal­lenge, a se­cre­tive lab the tech gi­ant start­ed in 2014 to work on can­cer re­search among a num­ber of oth­er ef­forts, and was first re­port­ed in Busi­ness In­sid­er. Ac­cord­ing to clin­i­cal­tri­, the Phase I tri­al will test a tu­mor anti­gen vac­cine ther­a­py along­side nivolum­ab (Op­di­vo) in pa­tients with metasta­t­ic and re­frac­to­ry late stage melanoma and HR+/HER2- breast can­cer.

The vac­cine is per­son­al­ized with a com­bi­na­tion of each pa­tient’s own tu­mor anti­gens, and the goal is to in­duce T cell ac­tiv­i­ty against the tu­mors ex­press­ing those anti­gens. The ear­ly stage tri­al test­ing safe­ty of the vac­cine aims to en­roll 20 pa­tients.

The idea of can­cer vac­cines has been float­ed around for years, but has nev­er quite tak­en off. Provenge, a prostate can­cer vac­cine, was ap­proved back in 2010 but strug­gled in the mar­ket, and its mak­er Den­dreon filed for bank­rupt­cy in 2014. (The com­pa­ny has since piv­ot­ed to of­fer con­tract man­u­fac­tur­ing ser­vices.)

Known for its Pfiz­er-part­nered Covid vac­cine, BioN­Tech has al­so seen mid­dling re­sults with its per­son­al­ized can­cer vac­cine. How­ev­er, that hasn’t slowed the biotech, as it con­tin­ues to test an mR­NA can­cer vac­cine part­ner­ship with Genen­tech and re­cent­ly ex­pand­ed its col­lab­o­ra­tion with Re­gen­eron.

Jeff Be­zos him­self has pre­vi­ous­ly fund­ed a num­ber of oth­er R&D ef­forts, most in­fa­mous­ly in the an­ti-ag­ing space. The bil­lion­aire is a backer of Al­tos Labs, an an­ti-ag­ing play where No­bel lau­re­ates Jen­nifer Doud­na and Shinya Ya­mana­ka are in­volved. He is al­so a backer of Uni­ty Biotech­nol­o­gy, which re­cent­ly start­ed a Phase II tri­al for a small mol­e­cule treat­ment for age-re­lat­ed mac­u­lar de­gen­er­a­tion.

On its new part­ner­ship, Fred Hutch said in an emailed state­ment:

Fred Hutch is work­ing with Ama­zon to ex­plore the de­vel­op­ment of a per­son­al­ized treat­ment for cer­tain forms of can­cer. Fred Hutch re­cent­ly re­ceived per­mis­sion from the U.S. Food and Drug Ad­min­is­tra­tion to pro­ceed with a Phase I clin­i­cal tri­al, which is now un­der­way. It’s very ear­ly in a long, mul­ti-year process, and suc­cess is by no means guar­an­teed. The pro­gram is an im­por­tant ex­am­ple of how Fred Hutch works with col­lab­o­ra­tors to de­vel­op new ther­a­pies.

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.