Sanofi sends a pair of gene ther­a­pies back to Ox­ford Bio­med­ica. Are they sal­vage­able?

The same day Ox­ford Bio­med­ica signed a 5-year deal to make As­traZeneca’s Covid-19 vac­cine, the UK gene ther­a­py com­pa­ny an­nounced they re­ceived word Sanofi was send­ing a cou­ple of decade-old ex­per­i­men­tal drugs back to them.

In 2009, Sanofi and Bio­med­ica slashed a co-de­vel­op­ment deal on TroVax, a can­cer vac­cine that had been one of the cen­ter­pieces of the then 14-year-old com­pa­ny. But the pair im­me­di­ate­ly re­placed it with a deal, 8 years be­fore the ap­proval of Spark Ther­a­peu­tics’ Lux­tur­na, to de­vel­op gene ther­a­pies for two eye-re­lat­ed dis­or­ders.

Now, with lit­tle to show for it but a pair of very ear­ly stud­ies, Sanofi is kick­ing the ther­a­pies back to Bio­med­ica. The French drug­mak­er had al­ready an­nounced last year, amid an in­ter­nal shake­up, that they were not in­ter­est­ed in de­vel­op­ing the drugs fur­ther, but what would hap­pen to the ther­a­pies hung in the air.

In some ways, it still does. Bio­med­ica wouldn’t com­mit to pro­gress­ing or re­tir­ing them. It wasn’t even clear when Bio­med­ica would re­gain the rights.

“The tim­ing of re­turn of these pro­grams and op­er­a­tional de­tails are yet to be de­ter­mined,” the biotech said in a state­ment. “How­ev­er, when the rights to the two pro­grams are re­turned, the group will un­der­take its own in­ter­nal eval­u­a­tion to de­ter­mine the po­ten­tial fu­ture for these pro­grams and de­cide whether to com­mit fur­ther re­sources to them.”

Bio­med­ica’s $100 mil­lion part­ner­ship with Sanofi’s rare blood dis­or­der sub­sidiary Biover­a­tiv re­mains in­tact.

The two gene ther­a­pies are SAR422459, for treat­ing a pro­gres­sive mac­u­lar dis­ease called Star­gardt dis­ease, and SAR421869, for treat­ing Ush­er’s Syn­drome, a dis­or­der that can cause both vi­sion and hear­ing loss. The Star­gardt ther­a­py be­gan a Phase I/II study in France in 2011, but the study was end­ed pre­ma­ture­ly last Au­gust af­ter Sanofi repri­or­i­tized its pipeline. Al­though the study was de­signed to mea­sure bi­o­log­i­cal mark­ers of ef­fi­ca­cy, Sanofi in­clud­ed no such da­ta when it post­ed re­sults on clin­i­cal­tri­als.gov ear­li­er this year.

The ther­a­py for Ush­er’s Syn­drome en­tered its Phase I/II study in 2012. That study was sus­pend­ed in 2017 while Sanofi re­viewed its pipeline and then al­so ter­mi­nat­ed last year.

If Bio­med­ica con­sid­ers the ther­a­pies to still have po­ten­tial, it’s like­ly they will try to out-li­cense them again. The com­pa­ny is built around part­ner­ships, li­cens­ing out a few in-house can­di­dates and help­ing man­u­fac­ture No­var­tis’s CAR-T ther­a­py Kym­ri­ah and, as of yes­ter­day, As­traZeneca’s Covid-19 vac­cine.  They are ex­plic­it­ly not a com­mer­cial-stage biotech. All of the pre­clin­i­cal can­di­dates on its web­site are list­ed as “to be spun out, or out-li­censed,” and they run no clin­i­cal tri­als.

So the best ques­tion may be not whether Bio­med­ica sees po­ten­tial, but if any­one else does.

So­cial: Shut­ter­stock

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.