Car­olyn Bertozzi (Illustration: Assistant editor Kathy Wong for Endpoints News)

Car­olyn Bertozzi, re­peat biotech founder and launch­er of a field, shares in chem­istry No­bel win

Car­olyn Bertozzi, pre­dict­ed by some to be­come a No­bel lau­re­ate, clinched one of the world’s top awards in the wee hours of Wednes­day, win­ning the No­bel Prize in Chem­istry along­side a re­peat win­ner and a Copen­hagen re­searcher.

The Stan­ford pro­fes­sor, Morten Mel­dal of Uni­ver­si­ty of Copen­hagen and 2001 awardee K. Bar­ry Sharp­less of Scripps shared the prize equal­ly. The No­bel is some­times split in quar­ters and/or halves.

“I am ab­solute­ly stunned. I am sit­ting here and can hard­ly breathe,” Bertozzi said to the com­mit­tee in the mid­dle of the night Cal­i­for­nia time. “I’m still not en­tire­ly pos­i­tive that it’s re­al, but it’s get­ting re­al by the minute.”

The in-the-mo­ment re­ac­tion was re­flect­ed sim­i­lar­ly in her in­ter­nal com­mu­ni­ca­tion with her lab group. The sub­ject line: “I can’t be­lieve it’s re­al.” The body of the note: “Ap­par­ent­ly it is!”

Sharp­less and Mel­dal won for their con­tri­bu­tions to so-called click chem­istry. Bertozzi el­e­vat­ed the find­ings by find­ing click re­ac­tions that weren’t tox­ic to cells and made “chem­i­cal re­ac­tions that don’t in­ter­fere with the nor­mal bio­chem­istry of life. This now al­lows us to at­tach all kinds of mol­e­cules to bi­o­log­i­cal ones,” the Roy­al Swedish Acad­e­my of Sci­ences said in its an­nounce­ment.

Bertozzi, the new­ly-mint­ed No­bel lau­re­ate, spear­head­ed the field of bioorthog­o­nal chem­istry to help map cells. She joins just sev­en oth­er women grant­ed the award — out of 191 lau­re­ates — in­clud­ing CRISPR pi­o­neers Jen­nifer Doud­na and Em­manuelle Char­p­en­tier for their ground­break­ing Cas9 gene edit­ing work that has el­e­vat­ed both to new heights and made Doud­na a house­hold name in some cir­cles.

Sharp­less joins a lim­it­ed club of re­peat win­ners: John Bardeen (’56, ’72), Marie Curie (’03, ’11), Li­nus Paul­ing (’54, ’62) and Fred­er­ick Sanger (’58, ’80). The No­bel com­mit­tee deemed Sharp­less the orig­i­na­tor of the “click chem­istry” con­cept, which they de­scribed as “sim­ple and re­li­able chem­istry” that al­low re­ac­tions to hap­pen fast and avoid un­de­sired byprod­ucts.

He and Mel­dal in­de­pen­dent­ly put to­geth­er the “crown jew­el” of click: the cop­per cat­alyzed azide-alkyne cy­cload­di­tion. The chem­i­cal re­ac­tion plays out in the de­vel­op­ment of drugs, map­ping DNA and cre­at­ing new ma­te­ri­als, the No­bel com­mit­tee wrote.

The No­bel Com­mit­tee for Chem­istry an­nounces the win­ners: Car­olyn Bertozzi, Morten Mel­dal and K. Bar­ry Sharp­less (Jonathan Nack­strand/AFP via Get­ty Im­ages)

Click on the im­age to see the full-sized ver­sion

In comes Bertozzi, who es­ca­lat­ed the work of Mel­dal and Sharp­less by map­ping gly­cans, bio­mol­e­cules on the sur­face of cells. Her de­vel­op­ments, in­clud­ing a met­al-free click re­ac­tion, work in­side hu­mans. The re­search is at the heart of new treat­ments be­ing test­ed in clin­i­cal tri­als to­day.

In sum­ma­ry, the trio’s find­ings have “tak­en chem­istry in­to the era of func­tion­al­ism.” On the press and com­mit­tee call right af­ter the an­nounce­ment, Bertozzi said bioorthog­o­nal and click chem­istry are “still in its ear­ly phas­es” and that the im­pacts will be seen in biotech and phar­ma for years to come.

Bertozzi’s work has led to the foun­da­tion of nine biotechs (a fig­ure she tal­lied up pri­or to an in­ter­view with End­points News in May), in­clud­ing Palleon Phar­ma­ceu­ti­cals, In­ter­Venn, Ly­cia Ther­a­peu­tics and oth­ers. The lat­ter came to­geth­er out of a 24-hour hum­drum of ven­ture cap­i­tal in­ter­est af­ter she tweet­ed out a preprint her group had post­ed on Chem­Rx­iv that de­scribed LY­TACs, she pre­vi­ous­ly re­called to End­points.

Asked by re­porters what ap­pli­ca­tions of her she thinks are mak­ing a lot of im­pact, she said in med­i­cine, the main one is the de­liv­ery of ther­a­peu­tics “to make sure that drugs go to the right place and stay away from the wrong place.”

Bertozzi di­rects Stan­ford’s Sarafan ChEM-H, short for Chem­istry, En­gi­neer­ing, and Med­i­cine for Hu­man Health. She in­flu­ences the next gen­er­a­tion as a teacher but al­so as a par­ent who helps with her chil­dren’s sci­ence fair projects. Mu­si­cal in­ter­ests pop­u­late her free time as she en­joys play­ing pop, rock n’ roll and jazz songs on the pi­ano, and oc­ca­sion­al­ly “keep[s] up with karaoke nights at some of the clubs in San Fran­cis­co.” She’s al­so a self-pro­claimed “fit­ness buff.”

The Howard Hugh­es Med­ical In­sti­tute in­ves­ti­ga­tor has al­so co-found­ed Grace Sci­ence, a biotech that is at­tempt­ing to trans­late re­search out of the Grace Sci­ence Foun­da­tion to cre­ate treat­ments for NG­LY1 de­fi­cien­cy and oth­er in­di­ca­tions. Bertozzi has served on the Eli Lil­ly board of di­rec­tors and re­search ad­vi­so­ry board at GSK.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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In­dus­try groups, CVS pick apart FDA's pro­posed path­way for gener­ics to carve out OTC in­di­ca­tions

Pharma industry groups like the Association for Accessible Medicines (AAM) and PhRMA are raising pointed questions about an FDA plan to create a new pathway for marketing prescription drugs with an additional condition for nonprescription use (ACNU), which would require more safeguards than the current OTC pathway but essentially carve out new OTC uses for some generic drugs.

Chief among the concerns were: Insurance companies dropping coverage for the Rx version, new ACNU patents to block competition, and industry essentially governing the pathway.

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Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.

The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.

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Eli Casdin

Near­ly a year af­ter his SPAC com­bines with EQRx, Eli Cas­din re­signs from board

About 11 months after his investment firm’s blank check company helped boost EQRx’s cash coffers by about $1.3 billion, Eli Casdin is out from the biotech’s board.

The day before Thanksgiving, he told EQRx’s board that he would resign at the end of that day, according to an SEC filing. The decision “was not due to any disagreement with EQRx” relating to the company’s “operations, policies or practices,” as the biotech outlined in the paperwork with the agency.

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