Glax­o­SmithK­line's vac­cines group aims for a first as it kicks off PhI­II RSV stud­ies

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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

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.

Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

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.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

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.

Emer Cooke, EMA director (AP Photo/Geert Vanden Wijngaert)

Ahead of FDA, EMA rec­om­mends au­tho­riz­ing new gene ther­a­py treat­ment for ul­tra-rare dis­ease

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 tries to post-hoc-an­a­lyze its way out of an­oth­er tri­al fail for stroke stem cell ther­a­py

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.

Siddhartha Mukherjee (Brian Ach/Getty Images for The New Yorker)

All Blue's $733M bid to ac­quire Zymeworks turns hos­tile as board bat­tles back — af­ter a biotech celebri­ty jumps in

Yesterday, the team at All Blue Capital — bent on the takeover of a badly battered Zymeworks — brought in celebrated oncologist, Pulitzer prize-winning writer and biotech exec Siddhartha Mukherjee to add some glitz to their proposed board. But they’re still not winning over any converts.

This morning, Zymeworks’ board officially turned this acquisition offer into a hostile showdown, rejecting the unsolicited offer and marshaling its forces to prevent a buyout at $10.50 per share.

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