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 clin­i­cal­tri­als.gov, 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.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Isao Teshirogi, Shionogi president and CEO (Kyodo via AP Images)

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.

The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.