Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throw­ing in the tow­el on mR­NA-based Covid-19 vac­cines.

The French drug­mak­er will halt de­vel­op­ment on its un­mod­i­fied mR­NA Covid-19 shot de­spite what it said were pos­i­tive Phase I/II re­sults, a spokesper­son told End­points News on Tues­day morn­ing. Sanofi said the rea­son it’s stop­ping the Covid-19 mR­NA pro­gram, de­vel­oped in part­ner­ship with its new $3.2 bil­lion ac­qui­si­tion Trans­late Bio, is be­cause the mar­ket is too crowd­ed.

“Our am­bi­tion is to make a sig­nif­i­cant and rel­e­vant con­tri­bu­tion to the on­go­ing pan­dem­ic,” the spokesper­son, Nico­las Kress­mann, wrote to End­points in an email. “From a pub­lic health per­spec­tive, mR­NA Covid vac­cines are wide­ly avail­able to­day so it does not make sense for us to fur­ther ad­vance our mR­NA Covid vac­cine in­to Phase III.”

The move rep­re­sents a quick punt from Sanofi, com­ing a lit­tle over a year af­ter CEO Paul Hud­son shelled out $425 mil­lion up­front to part­ner with Trans­late Bio on mR­NA vac­cines. Hud­son had seen enough pos­i­tive re­sults to ap­prove the full $3.2 bil­lion ac­qui­si­tion last month, but now Sanofi will set its sights on mR­NA pro­grams for flu and oth­er ar­eas rather than Covid-19.

When asked about oth­er mR­NA can­di­dates in de­vel­op­ment, Kress­mann point­ed to­ward Sanofi’s June launch of a Phase I study for its mR­NA flu shot. The com­pa­ny hopes to have six clin­i­cal mR­NA-based can­di­dates by 2025 across a wide range of in­di­ca­tions in­clud­ing in­fec­tious dis­ease, im­munol­o­gy and on­col­o­gy, he said.

The Covid-19 pro­gram from Trans­late us­es un­mod­i­fied mR­NA, which is dif­fer­ent from the vac­cines made by Pfiz­er/BioN­Tech and Mod­er­na. Un­mod­i­fied mR­NA ther­a­pies are ear­li­er it­er­a­tions of mR­NA tech­nol­o­gy that have gen­er­al­ly seen more pro­nounced in­nate im­mune re­spons­es — and, con­se­quent­ly, side ef­fects — in pa­tients. Sanofi said the Phase I/II tri­al saw no safe­ty con­cerns and had tol­er­a­bil­i­ty “com­pa­ra­ble to that of oth­er un­mod­i­fied mR­NA Covid-19 vac­cines.”

Some mR­NA com­pa­nies, in­clud­ing BioN­Tech and Mod­er­na, moved to­ward the mod­i­fied ver­sion af­ter a break­through by Uni­ver­si­ty of Penn­syl­va­nia sci­en­tists Katal­in Karikó and Drew Weiss­man showed it to be safer. The pair mod­i­fied one of the four nu­cle­o­sides that make up RNA to help the ther­a­pies bet­ter evade the body’s nat­ur­al de­fens­es.

Mov­ing for­ward, Kress­mann said Sanofi will pur­sue both un­mod­i­fied and mod­i­fied mR­NA-based treat­ments and vac­cines, with a par­tic­u­lar em­pha­sis on “ac­cel­er­at­ing” the mod­i­fied mR­NA tech­nol­o­gy. In ad­di­tion to the Phase I mR­NA flu shot study, Sanofi is shoot­ing to get a quadri­va­lent mR­NA flu vac­cine in­to the clin­ic in 2022.

“Based on the pos­i­tive re­sults that we have now, we are now ac­cel­er­at­ing our work to next-gen­er­a­tion mR­NA vac­cines and aim to work on a less re­ac­tive and more sta­ble tech­nol­o­gy, which is what makes sense now for pub­lic health,” he said.

Sanofi is still work­ing on its re­com­bi­nant Covid-19 vac­cine with Glax­o­SmithK­line, cur­rent­ly in Phase III, and launched a study to eval­u­ate the shot as a boost­er. The com­pa­nies are try­ing to po­si­tion the vac­cine as a boost­er for any Covid-19 shot, re­gard­less of plat­form, high­light­ing pre­clin­i­cal da­ta that they said “strong­ly boost­ed” im­mune re­spons­es.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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