Pfiz­er eyes po­ten­tial for co-ad­min­is­tra­tion of its new Pre­vnar 20 and the sea­son­al flu shot

Pfiz­er has joined the ranks of drug­mak­ers look­ing to com­bine sea­son­al vac­cines, re­veal­ing new da­ta on Wednes­day sug­gest­ing its fresh­ly ap­proved 20-va­lent pneu­mo­coc­cal vac­cine can be ad­min­is­tered at the same time as the flu shot in old­er adults.

When re­ceived to­geth­er in a group of vol­un­teers 65 years and old­er, re­spons­es elicit­ed by Pre­vnar 20 and the sea­son­al flu vac­cine were non-in­fe­ri­or to those elicit­ed by the vac­cines when re­ceived a month apart, Pfiz­er said, point­ing to new topline da­ta from a Phase III study. The safe­ty pro­file of Pre­vnar was sim­i­lar when the vac­cines were tak­en to­geth­er ver­sus apart.

“Both Pre­vnar 20 and the in­fluen­za vac­cine are im­por­tant for help­ing pro­tect adults against pneu­mo­coc­cal pneu­mo­nia and the flu re­spec­tive­ly; how­ev­er, vac­ci­na­tion rates de­cline when some­one needs to make mul­ti­ple ap­point­ments to re­ceive these vac­cines,” Pfiz­er Vac­cines CMO and se­nior VP Luis Jo­dar said in a state­ment.

Luis Jo­dar

Pfiz­er isn’t the on­ly com­pa­ny chas­ing this two-in-one ap­proach. Ear­li­er this month, Mod­er­na an­nounced it’s de­vel­op­ing a sin­gle vac­cine that com­bines a boost­er dose of its Covid-19 shot with its ex­per­i­men­tal flu shot. CEO Stéphane Ban­cel told End­points News back in April that the goal is to ex­plore can­di­dates that pro­tect against the flu, SARS-CoV-2, RSV and hu­man metap­neu­movirus (hM­PV).

“This is re­al­ly the big is­sue. If you could have a prod­uct that had high-ef­fi­ca­cy in Covid, high-ef­fi­ca­cy in flu and high-ef­fi­ca­cy in RSV, you will have a mas­sive im­pact on pub­lic health, and hos­pi­tal­iza­tion and mor­tal­i­ty of el­der­ly,” he said at the time.

No­vavax — whose ex­per­i­men­tal Covid-19 vac­cine has been hit with mul­ti­ple de­lays — al­so launched an ear­ly-stage tri­al this month test­ing a com­bi­na­tion of its in­fluen­za and Covid can­di­dates, and ex­pects da­ta in the first half of next year. Glax­o­SmithK­line, on the oth­er hand, knows this space well. The phar­ma won an ap­proval for its Kin­rix shot — the first com­bi­na­tion vac­cine to of­fer pro­tec­tion against diph­the­ria, tetanus, per­tus­sis and po­lio — back in 2008.

Pfiz­er says more da­ta from its pneu­mo­coc­cal and flu com­bi­na­tion tri­al — which in­clud­ed 1,727 par­tic­i­pants — are com­ing in the fu­ture. But in the mean­time, it has an­oth­er tri­al in the works ex­plor­ing the co-ad­min­is­tra­tion of Pre­vnar 20 and a boost­er dose of its Covid-19 vac­cine, Comir­naty, in adults 65 and old­er.

Pre­vnar 20 was ap­proved back in June, beat­ing Mer­ck and its 15-va­lent shot to the punch. The vac­cine cov­ers all 13 strains that its pre­de­ces­sor Pre­vnar 13 does, plus 8, 10A, 11A, 12F, 15B, 22F and 33F.

There are cur­rent­ly two main types of pneu­mo­coc­cal vac­cine: pneu­mo­coc­cal con­ju­gate vac­cines (PCV) and pneu­mo­coc­cal poly­sac­cha­ride vac­cines (PPSV). Both con­tain poly­sac­cha­rides tak­en from serotypes of S. pneu­mo­niae bac­te­ria, which cause pa­tients’ im­mune sys­tems to de­vel­op an­ti­bod­ies that will lat­er rec­og­nize that poly­sac­cha­ride.

Mer­ck came out with its 23-va­lent PPSV, Pneu­movax 23, back in 1983. How­ev­er, PPSVs have been shown to have poor per­for­mance in younger chil­dren. As a so­lu­tion, drug­mak­ers have de­vel­oped “con­ju­gat­ed” vac­cines, in which the poly­sac­cha­rides are at­tached to a car­ri­er pro­tein.

As Mer­ck and Pfiz­er duke it out, a 24-va­lent can­di­date is in the mak­ing that hopes to top­ple them both. Vax­cyte, for­mer­ly known as SutroVax, is in ear­ly de­vel­op­ment with VAX-24 and ex­pects to file an IND in the first half of 2022.

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.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Ed Kaye, Stoke Therapeutics CEO

Stoke touts ear­ly signs of ef­fi­ca­cy for Dravet syn­drome drug

Two and a half years after driving his antisense oligonucleotide platform to Wall Street, Stoke Therapeutics CEO Ed Kaye is painting a fuller picture of the company’s first clinical data. And though the trial wasn’t powered to detect statistical significance, Kaye says the readout shows early signs of efficacy in kids with a rare, drug-resistant form of epilepsy

STK-001 was well-tolerated in single and multiple doses in 22 Dravet syndrome patients between the ages of 2 and 18 years old, Stoke announced on Friday. What’s more, 12 of the 17 evaluable patients at the time (70.6%) saw reductions from baseline in convulsive seizure frequency, according to the company.