{"id":63362,"date":"2026-01-10T10:47:39","date_gmt":"2026-01-10T10:47:39","guid":{"rendered":"https:\/\/youzum.net\/a-new-crispr-startup-is-betting-regulators-will-ease-up-on-gene-editing\/"},"modified":"2026-01-10T10:47:39","modified_gmt":"2026-01-10T10:47:39","slug":"a-new-crispr-startup-is-betting-regulators-will-ease-up-on-gene-editing","status":"publish","type":"post","link":"https:\/\/youzum.net\/it\/a-new-crispr-startup-is-betting-regulators-will-ease-up-on-gene-editing\/","title":{"rendered":"A new CRISPR startup is betting regulators will ease up on gene-editing"},"content":{"rendered":"

Here at MIT<\/em> Technology Review<\/em> we\u2019ve been writing about the gene-editing technology CRISPR since 2013, calling it the biggest biotech breakthrough of the century. Yet so far, there\u2019s been only one gene-editing drug<\/a> approved. It\u2019s been used commercially on only about 40 patients, all with sickle-cell disease.<\/p>\n

It\u2019s becoming clear that the impact of CRISPR isn\u2019t as big as we all hoped. In fact, there\u2019s a pall of discouragement over the entire field\u2014with some journalists saying the gene-editing revolution has \u201clost its mojo<\/a>.\u201d<\/p>\n

So what will it take for CRISPR to help more people? A new startup says the answer could be an \u201cumbrella approach\u201d to testing and commercializing treatments. Aurora Therapeutics, which has $16 million from Menlo Ventures and counts CRISPR co-inventor Jennifer Doudna as an advisor, essentially hopes to win approval for gene-editing drugs that can be slightly adjusted, or personalized, without requiring costly new trials or approvals for every new version.<\/p>\n

The need to change regulations around gene-editing treatments was endorsed in November<\/a> by the head of the US Food and Drug Administration, Martin Makary, who said the agency would open a \u201cnew\u201d regulatory pathway for \u201cbespoke, personalized therapies\u201d that can\u2019t easily be tested in conventional ways.\u00a0<\/p>\n

Aurora\u2019s first target, the rare inherited disease phenylketonuria, also known as PKU, is a case in point. People with PKU lack a working version of an enzyme needed to use up the amino acid phenylalanine, a component of pretty much all meat and protein. If the amino acid builds up, it causes brain damage. So patients usually go on an onerous \u201cdiet for life\u201d of special formula drinks and vegetables.<\/p>\n

In theory, gene editing can fix PKU. In mice, scientists have already re<\/a>stored the gene for the enzyme by rewriting DNA in liver cells, which both make the enzyme and are some of the easiest to reach with a gene-editing drug. The problem is that in human patients, many different mutations can affect the critical gene. According to Cory Harding, a researcher at Oregon Health Sciences University, scientists know about 1,600 different DNA mutations that cause PKU.<\/p>\n

There\u2019s no way anyone will develop 1,600 different gene-editing drugs. Instead, Aurora\u2019s goal is to eventually win approval for a single gene editor that, with minor adjustments, could be used to correct several of the most common mutations, including one that\u2019s responsible for about 10% of the estimated 20,000 PKU cases in the US.<\/p>\n

\u201cWe can\u2019t have a separate clinical trial for each mutation,\u201d says Edward Kaye, the CEO of Aurora. \u201cThe way the FDA approves gene editing has to change, and I think they\u2019ve been very understanding that is the case.\u201d<\/p>\n

A gene editor is a special protein that can zero in on a specific location in the genome and change it. To prepare one, Aurora will put genetic code for the editor into a nanoparticle along with a targeting molecule. In total, it will involve about 5,000 gene letters. But only 20 of them need to change in order to redirect the treatment to repair a different mutation.<\/p>\n

\u201cOver 99% of the drug stays the same,\u201d says Johnny Hu, a partner at Menlo Ventures, which put up the funding for the startup.<\/p>\n

The new company came together after Hu met over pizza with Fyodor Urnov, an outspoken gene-editing scientist at the University of California, Berkeley, who is Aurora\u2019s cofounder and sits on its board.<\/p>\n

In 2022, Urnov had written a New York Times<\/em> editorial<\/a> bemoaning the \u201cchasm\u201d between what editing technology can do and the \u201clegal, financial, and organizational\u201d realities preventing researchers from curing people.<\/p>\n

\u201cI went to Fyodor and said, \u2018Hey, we\u2019re getting all these great results in the clinic with CRISPR, but why hasn\u2019t it scaled?\u201d says Hu. Part of the reason is that most gene-editing companies are chasing the same few conditions, such as sickle-cell, where (as luck would have it<\/a>) a single edit works for all patients. But that leaves around 400 million people who have 7,000 other inherited conditions without much hope to get their DNA fixed, Urnov estimated in his editorial.<\/p>\n

Then, last May, came the dramatic demonstration of the first fully \u201cpersonalized\u201d gene-editing treatment.<\/a> A team in Philadelphia, assisted by Urnov and others, succeeded in correcting the DNA of a baby, named KJ Muldoon, who had an entirely unique mutation that caused a metabolic disease. Though it didn\u2019t target PKU, the project showed that gene editing could theoretically fix some inherited diseases \u201con demand.\u201d\u00a0<\/p>\n

It also underscored a big problem. Treating a single child required a large team and cost millions in time, effort, and materials\u2014all to create a drug that would never be used again.\u00a0<\/p>\n

That\u2019s exactly the sort of situation the new \u201cumbrella\u201d trials are supposed to address. Kiran Musunuru, who co-led the team at the University of Pennsylvania, says he\u2019s been in discussions<\/a> with the FDA to open a study of bespoke gene editors this year focusing on diseases of the type Baby KJ had, called urea cycle disorders. Each time a new patient appears, he says, they\u2019ll try to quickly put together a variant of their gene-editing drug that\u2019s tuned to fix that child\u2019s particular genetic problem.<\/p>\n

Musunuru, who isn\u2019t involved with Aurora, does not think the company\u2019s plans for PKU count as fully personalized editors. \u201cThese corporate PKU efforts have nothing whatsoever to do with Baby KJ,\u201d he says. He says his center continues to focus on mutations \u201cso ultra-rare that we don\u2019t see any scenario where a for-profit gene-editing company would find that indication to be commercially viable.\u201d<\/p>\n

Instead, what\u2019s occurring in PKU, says Musunuru, is that researchers have realized they can assemble \u201ca bunch\u201d of the most frequent mutations \u201cinto a large enough group of patients to make a platform PKU therapy commercially viable.\u201d\u00a0<\/p>\n

While that would still leave out many patients with extra-rare gene errors, Musunuru says any gene-editing treatment at all would still be \u201ca big improvement over the status quo, which\u00a0 is zero genetic therapies for PKU.\u201d<\/p>","protected":false},"excerpt":{"rendered":"

Here at MIT Technology Review we\u2019ve been writing about the gene-editing technology CRISPR since 2013, calling it the biggest biotech breakthrough of the century. Yet so far, there\u2019s been only one gene-editing drug approved. It\u2019s been used commercially on only about 40 patients, all with sickle-cell disease. It\u2019s becoming clear that the impact of CRISPR isn\u2019t as big as we all hoped. In fact, there\u2019s a pall of discouragement over the entire field\u2014with some journalists saying the gene-editing revolution has \u201clost its mojo.\u201d So what will it take for CRISPR to help more people? A new startup says the answer could be an \u201cumbrella approach\u201d to testing and commercializing treatments. Aurora Therapeutics, which has $16 million from Menlo Ventures and counts CRISPR co-inventor Jennifer Doudna as an advisor, essentially hopes to win approval for gene-editing drugs that can be slightly adjusted, or personalized, without requiring costly new trials or approvals for every new version. The need to change regulations around gene-editing treatments was endorsed in November by the head of the US Food and Drug Administration, Martin Makary, who said the agency would open a \u201cnew\u201d regulatory pathway for \u201cbespoke, personalized therapies\u201d that can\u2019t easily be tested in conventional ways.\u00a0 Aurora\u2019s first target, the rare inherited disease phenylketonuria, also known as PKU, is a case in point. People with PKU lack a working version of an enzyme needed to use up the amino acid phenylalanine, a component of pretty much all meat and protein. If the amino acid builds up, it causes brain damage. So patients usually go on an onerous \u201cdiet for life\u201d of special formula drinks and vegetables. In theory, gene editing can fix PKU. In mice, scientists have already restored the gene for the enzyme by rewriting DNA in liver cells, which both make the enzyme and are some of the easiest to reach with a gene-editing drug. The problem is that in human patients, many different mutations can affect the critical gene. According to Cory Harding, a researcher at Oregon Health Sciences University, scientists know about 1,600 different DNA mutations that cause PKU. There\u2019s no way anyone will develop 1,600 different gene-editing drugs. Instead, Aurora\u2019s goal is to eventually win approval for a single gene editor that, with minor adjustments, could be used to correct several of the most common mutations, including one that\u2019s responsible for about 10% of the estimated 20,000 PKU cases in the US. \u201cWe can\u2019t have a separate clinical trial for each mutation,\u201d says Edward Kaye, the CEO of Aurora. \u201cThe way the FDA approves gene editing has to change, and I think they\u2019ve been very understanding that is the case.\u201d A gene editor is a special protein that can zero in on a specific location in the genome and change it. To prepare one, Aurora will put genetic code for the editor into a nanoparticle along with a targeting molecule. In total, it will involve about 5,000 gene letters. But only 20 of them need to change in order to redirect the treatment to repair a different mutation. \u201cOver 99% of the drug stays the same,\u201d says Johnny Hu, a partner at Menlo Ventures, which put up the funding for the startup. The new company came together after Hu met over pizza with Fyodor Urnov, an outspoken gene-editing scientist at the University of California, Berkeley, who is Aurora\u2019s cofounder and sits on its board. In 2022, Urnov had written a New York Times editorial bemoaning the \u201cchasm\u201d between what editing technology can do and the \u201clegal, financial, and organizational\u201d realities preventing researchers from curing people. \u201cI went to Fyodor and said, \u2018Hey, we\u2019re getting all these great results in the clinic with CRISPR, but why hasn\u2019t it scaled?\u201d says Hu. Part of the reason is that most gene-editing companies are chasing the same few conditions, such as sickle-cell, where (as luck would have it) a single edit works for all patients. But that leaves around 400 million people who have 7,000 other inherited conditions without much hope to get their DNA fixed, Urnov estimated in his editorial. Then, last May, came the dramatic demonstration of the first fully \u201cpersonalized\u201d gene-editing treatment. A team in Philadelphia, assisted by Urnov and others, succeeded in correcting the DNA of a baby, named KJ Muldoon, who had an entirely unique mutation that caused a metabolic disease. Though it didn\u2019t target PKU, the project showed that gene editing could theoretically fix some inherited diseases \u201con demand.\u201d\u00a0 It also underscored a big problem. Treating a single child required a large team and cost millions in time, effort, and materials\u2014all to create a drug that would never be used again.\u00a0 That\u2019s exactly the sort of situation the new \u201cumbrella\u201d trials are supposed to address. Kiran Musunuru, who co-led the team at the University of Pennsylvania, says he\u2019s been in discussions with the FDA to open a study of bespoke gene editors this year focusing on diseases of the type Baby KJ had, called urea cycle disorders. Each time a new patient appears, he says, they\u2019ll try to quickly put together a variant of their gene-editing drug that\u2019s tuned to fix that child\u2019s particular genetic problem. Musunuru, who isn\u2019t involved with Aurora, does not think the company\u2019s plans for PKU count as fully personalized editors. \u201cThese corporate PKU efforts have nothing whatsoever to do with Baby KJ,\u201d he says. He says his center continues to focus on mutations \u201cso ultra-rare that we don\u2019t see any scenario where a for-profit gene-editing company would find that indication to be commercially viable.\u201d Instead, what\u2019s occurring in PKU, says Musunuru, is that researchers have realized they can assemble \u201ca bunch\u201d of the most frequent mutations \u201cinto a large enough group of patients to make a platform PKU therapy commercially viable.\u201d\u00a0 While that would still leave out many patients with extra-rare gene errors, Musunuru says any gene-editing treatment at all would still be \u201ca big improvement over the status quo, which\u00a0 is zero genetic therapies for PKU.\u201d<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_pvb_checkbox_block_on_post":false,"footnotes":""},"categories":[52,5,7,1],"tags":[],"class_list":["post-63362","post","type-post","status-publish","format-standard","hentry","category-ai-club","category-committee","category-news","category-uncategorized","pmpro-has-access"],"acf":[],"yoast_head":"\nA new CRISPR startup is betting regulators will ease up on gene-editing - 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Yet so far, there\u2019s been only one gene-editing drug approved. It\u2019s been used commercially on only about 40 patients, all with sickle-cell disease. It\u2019s becoming clear that the impact of CRISPR…","_links":{"self":[{"href":"https:\/\/youzum.net\/it\/wp-json\/wp\/v2\/posts\/63362","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/youzum.net\/it\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/youzum.net\/it\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/youzum.net\/it\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/youzum.net\/it\/wp-json\/wp\/v2\/comments?post=63362"}],"version-history":[{"count":0,"href":"https:\/\/youzum.net\/it\/wp-json\/wp\/v2\/posts\/63362\/revisions"}],"wp:attachment":[{"href":"https:\/\/youzum.net\/it\/wp-json\/wp\/v2\/media?parent=63362"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/youzum.net\/it\/wp-json\/wp\/v2\/categories?post=63362"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/youzum.net\/it\/wp-json\/wp\/v2\/tags?post=63362"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}