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.

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.