One of Glax­o­SmithK­line’s big projects at its glob­al vac­cine R&D cen­ter in Rockville, MD is set to en­ter Phase III af­ter pass­ing ear­ly-stage tests with fly­ing col­ors.

Eye­ing the wide-open res­pi­ra­to­ry syn­cy­tial virus (RSV) space, GSK is push­ing two dif­fer­ent vac­cine can­di­dates: GSK3888550A is de­signed to con­fer pro­tec­tion to in­fants via ma­ter­nal im­mu­niza­tion, while GSK3844766A is meant for the el­der­ly.

The phar­ma gi­ant pre­sent­ed Phase I/II da­ta for both at ID Week. Three dif­fer­ent dos­es of the ma­ter­nal can­di­date were test­ed among 502 healthy non-preg­nant women and in­ves­ti­ga­tors re­port­ed “high lev­els” of pro­tec­tive neu­tral­iz­ing an­ti­bod­ies. For the old­er adults can­di­date, the 60-to-80-year-old vac­ci­nat­ed group had “a close to 10 times in­crease of pro­tec­tive an­ti­bod­ies” com­pared to place­bo, cou­pled with CD4+ T cells boost­ed to sim­i­lar lev­els ob­served in younger adults who were giv­en the vac­cine in the lead-in phase.

Em­manuel Hanon

“We are de­light­ed to see these pos­i­tive re­sults con­firm­ing our ap­proach to de­vel­op ded­i­cat­ed vac­cines build­ing on the strate­gic use of our plat­form tech­nolo­gies for the pop­u­la­tions most at risk from RSV in­fec­tions – young in­fants and old­er adults,” Em­manuel Hanon, SVP and head of vac­cines R&D, said in a state­ment.

A lead­ing cause of res­pi­ra­to­ry in­fec­tions and pneu­mo­nia for chil­dren and the el­der­ly, RSV has been an elu­sive tar­get for vac­cine de­vel­op­ers.

Be­fore No­vavax be­came a fa­vorite to de­liv­er a shot for Covid-19, RSV was a key fo­cus in the pipeline. De­spite mul­ti­ple Phase III flops, the biotech in­sist­ed that they had a come­back plan for the Gates Foun­da­tion-backed pro­gram by high­light­ing pre­ven­tion of se­ri­ous con­se­quences. And a host of biotechs, in­clud­ing Meis­sa and Coda­genix, have bagged con­sid­er­able ven­ture cash to ex­plore new ways of as­sem­bling a vac­cine.

GSK’s ap­proach in­volves ad­min­is­ter­ing a re­com­bi­nant sub­unit pre-fu­sion RSV anti­gen to preg­nant women and com­bin­ing it with its ad­ju­vant sys­tem, AS01, to boost the im­mune re­sponse among old­er adults. AS01 is al­so used in GSK’s new shin­gles vac­cine, Shin­grix.

Phase III stud­ies for both can­di­dates are on track to start in the com­ing months, ac­cord­ing to the com­pa­ny. A third pe­di­atric pro­gram, which tar­gets both in­fants, is in Phase I/II for RSV-seroneg­a­tive pop­u­la­tions and Phase II for a RSV-seropos­i­tive group.

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AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Aromatic amino acid decarboxylase (AADC) deficiency is an ultra-rare genetic disease that leaves patients unable to produce certain hormones in the brain, such as dopamine and serotonin, usually leading to developmental delays, weak muscle tone and inability to control the movement of the limbs. It can also lead to multiple organ failure.

To date, there have been no treatments approved for AADC deficiency, which has been identified in less than 150 patients.

Athersys’ stem cell therapy has failed yet again.

In a 206-person trial conducted in Japan, Athersys’ stem cell therapy for stroke failed its primary endpoint of “excellent outcome,” a combined measure of three stroke recovery scores.

While a greater percentage of patients in the treatment group reached the primary endpoint compared to placebo, that difference was not statistically significant.