Glax­o­SmithK­line moves malar­ia vac­cine pro­duc­tion to In­dia; Nevakar bags Eu­ro­pean part­ner and nine-fig­ure deal

GSK is shift­ing pro­duc­tion of its malar­ia vac­cine to a Covid-19 vac­cine de­vel­op­er in In­dia.

Wednes­day’s move to Bharat Biotech was made as part of ef­forts to bat­tle the dead­ly fever, as GSK’s vac­cine is the first to prove ef­fec­tive in com­bat­ing the dis­ease. Bharat will take over man­u­fac­tur­ing of the pro­tein part of the vac­cine while GSK con­tin­ues de­vel­op­ing the ad­ju­vant por­tion of the shot.

The vac­cine is cur­rent­ly be­ing pi­lot­ed in re­gions of Ghana, Kenya and Malawi un­der the Malar­ia Vac­cine Im­ple­men­ta­tion Pro­gram. More than 500,000 chil­dren have re­ceived the first dose since the pi­lots were ini­ti­at­ed by the three coun­tries in 2019.

GSK has com­mit­ted to pro­vid­ing 10 mil­lion dos­es for the pi­lot pro­grams and 15 mil­lion an­nu­al­ly through 2028. The com­pa­nies ex­pect that by 2029, Bharat Biotech will take over as the sole sup­pli­er of the vac­cine while GSK con­tin­ues to pro­vide the ad­ju­vant.

Ac­cord­ing to the WHO, there were 229 mil­lion cas­es of malar­ia world­wide in 2019, with 94% of cas­es and deaths oc­cur­ring in Africa. — Max Gel­man

Oph­thal­mol­o­gy biotech bags a Eu­ro­pean part­ner and a deal worth up to $135M

New Jer­sey-based Nevakar has a Eu­ro­pean part­ner for a new treat­ment that aims to slow my­opia in chil­dren.

Lab­o­ra­toires Théa in France is tak­ing on the pro­gram, look­ing to launch in Eu­rope pro­vid­ed Nevakar can get this ther­a­py over the EMA’s reg­u­la­to­ry goal line with NVK-002. And the com­pa­ny will pay up to $135 mil­lion in mile­stones — along with roy­al­ties from any sales.

“Nevakar’s NVK-002 is the most ad­vanced and in­no­v­a­tive at­ropine prod­uct for the treat­ment of my­opia. When ap­proved, it will help ad­dress un­met needs in chil­dren’s eye care,” stat­ed Jean-Frédéric Chi­bret, the pres­i­dent of Théa. — John Car­roll

En­thera ex­tends largest-ever Ital­ian Se­ries A

En­thera Phar­ma­ceu­ti­cals, which in Ju­ly bagged the largest Se­ries A ever for an Ital­ian biotech, just added some more cash to its fund­ing round.

The biotech ex­tend­ed the fundrais­ing by €7 mil­lion, and has now raised a to­tal of €35 mil­lion for the round. In­vestors from the Roche Ven­ture Fund hopped on to the ex­ten­sion, join­ing a group that al­ready in­clud­ed Sofinno­va Part­ners and Ab­b­Vie Ven­tures.

As part of the Se­ries A round, Roche Ven­ture Fund chief Ca­r­ole Nuechter­lein joins the com­pa­ny’s board of di­rec­tors.

En­thera is us­ing “non­tra­di­tion­al” tech­nol­o­gy to tar­get au­toim­mune dis­eases, look­ing to re-es­tab­lish stem cell ca­pa­bil­i­ties in Type 1 di­a­betes and in­flam­ma­to­ry bow­el dis­ease.

“These funds raised will en­able us to ac­cel­er­ate our lead pro­gram Ent001 to clin­i­cal proof-of-con­cept,” CEO Gio­van­ni Am­a­bile said in a state­ment. “Through this and our wider pipeline, we hope to de­vel­op safe, ef­fec­tive treat­ments.”

— Max Gel­man

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

Sci­wind gets li­cens­ing deal with Sanofi for meta­bol­ic dis­ease can­di­dates; Im­mu­ni­ty­Bio and En­Gene­IC reach deal for nano cell tech

Sciwind Biosciences announced last night that it signed an expansive license agreement with Sanofi to develop and commercialize Sanofi’s long-lasting glucose-dependent insulinotropic polypeptide (GIP) receptor agonists. According to Sciwind, the lead candidate is currently under preclinical development.

The deal covers all applicable indications for the molecule. Sciwind plans to develop the lead GIP receptor agonist as part of combination with XWoo3, its GLP-1 peptide candidate which is currently being evaluated in Phase II studies to potentially treat diabetes, obesity and NASH.