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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

David Hung, Nuvation Bio president and CEO (Nuvation Bio)

FDA places par­tial clin­i­cal hold on David Hung biotech af­ter cer­tain can­cer pa­tients ex­pe­ri­ence eye in­flam­ma­tion

Two and a half years after setting out on another foray into oncology R&D, a biotech headed by David Hung — of Medivation fame — has run into its first setback.

San Francisco-based Nuvation Bio announced early Monday the FDA placed a partial clinical hold on a Phase I dose-escalation study of NUV-422, its CDK inhibitor program for certain types of solid tumors. The trial began enrolling patients in December 2020, and, according to Nuvation, researchers were in the middle of exploring dose escalation and defining the maximum dose tolerable in patients.