Sanofi builds on mR­NA al­liances with an $805M pact for Ron Re­naud’s Trans­late Bio

A year af­ter Ron Re­naud’s team at RaNA bagged rights to an RNA plat­form at Shire and re­launched as Trans­late Bio, the group has scored a big phar­ma al­liance with Sanofi.

Ron Re­naud

The French gi­ant is hand­ing over a $45 mil­lion up­front to part­ner with Trans­late, which will now set out to de­vel­op mes­sen­ger RNA vac­cines for up to 5 tar­gets. Trans­late will al­so be in line for up to $760 mil­lion in mile­stone cash if the work proves suc­cess­ful.

The deal comes just days af­ter Trans­late Bio filed for a $115 mil­lion IPO, look­ing to join the queue lin­ing up at Nas­daq. In the S-1, the biotech re­vealed that Shire owns about 20% of the com­pa­ny, mak­ing it the biotech’s largest share­hold­er.

Mes­sen­ger RNA vac­cines have al­so been a key ear­ly fo­cus at Mod­er­na, which has hoped to prove its po­ten­tial — and back its uni­corn sta­tus — through its ini­tial vac­cines work. In the mean­time, ri­vals in the field have al­so been an­te­ing up to play in the vac­cines field as well.

John Shiv­er

Sanofi is a well known play­er in the vac­cines field, but its home­grown dengue vac­cine has im­plod­ed af­ter fears were stoked that the jab raised se­ri­ous risks, par­tic­u­lar­ly among younger chil­dren not yet ex­posed to the vac­cine.  The WHO, which ini­tial­ly backed the vac­cine, has since with­drawn their sup­port and urged physi­cians to de­ter­mine if the peo­ple get­ting the vac­cine have been ex­posed to the virus first. 

In the mean­time, Sanofi has been steadi­ly ex­pand­ing on its ex­ter­nal R&D ef­forts, strik­ing col­lab­o­ra­tion deals like this with an eye to suck­ing in new tech­nolo­gies and ex­per­tise. The whole no­tion about mR­NA in this field rests on the idea that new ther­a­pies can de­liv­er the nu­cleotide se­quence en­cod­ing a pro­tein that can guard against a pathogen. And if it works, it can be man­u­fac­tured less ex­pen­sive­ly and in bulk.

Sanofi has some ex­pe­ri­ence in the field, sign­ing up with BioN­Tech on a col­lab­o­ra­tion more than two years ago. They have al­so been work­ing with Ger­many’s Cure­Vac. Shire se­cured an eq­ui­ty in­ter­est in RaNA in ex­change for its mR­NA work, but nei­ther com­pa­ny dis­closed how much of a stake the Lex­ing­ton, MA-based biotech came away with.

Said John Shiv­er, the head of R&D at Sanofi Pas­teur:

We be­lieve mR­NA tech­nol­o­gy has sig­nif­i­cant po­ten­tial for rapid and ver­sa­tile man­u­fac­tur­ing, re­duced in­dus­tri­al­iza­tion costs for mul­ti­ple vac­cines, and the im­proved breadth of im­mune re­sponse for in­fec­tious dis­ease vac­cines. The Trans­late Bio plat­form may al­low us to fur­ther ad­dress med­ical needs world­wide, in­clud­ing those not read­i­ly ac­ces­si­ble us­ing con­ven­tion­al vac­cine strate­gies.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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