Roy Baynes, Merck Research Laboratories CMO (file photo)

In tight next-gen pneu­mo­coc­cal vac­cine race with Pfiz­er, Mer­ck reads out topline pe­di­atric da­ta

The FDA is set to de­cide on Pfiz­er’s 20-va­lent pneu­mo­coc­cal con­ju­gate vac­cine for adults in June — a month be­fore Mer­ck’s PDU­FA date for its 15-va­lent can­di­date. But the Ke­nil­worth, NJ-based phar­ma isn’t go­ing down with­out a fight.

On Thurs­day, Mer­ck read out topline re­sults from two Phase III pe­di­atric stud­ies, and the com­pa­ny says it’s on track to sub­mit a sup­ple­men­tary BLA by the end of the year.

“Pneu­mo­coc­cal dis­ease con­tin­ues to cause se­ri­ous ill­ness and death world­wide in chil­dren un­der the age of 5, de­spite the pos­i­tive im­pact of pneu­mo­coc­cal con­ju­gate vac­ci­na­tion on pe­di­atric case num­bers,” Mer­ck Re­search Labs CMO Roy Baynes said in a state­ment.

Mer­ck’s can­di­date, V114, cov­ers the 13 serotypes cov­ered by Pfiz­er’s megablock­buster Pre­vnar 13, plus an ad­di­tion­al two: 22F and 33F.

In the first pe­di­atric tri­al, dubbed PNEU-PLAN, Mer­ck pit­ted V114 against Pre­vnar 13 in 606 kids be­tween the ages of 7 months and 17 years who hadn’t pre­vi­ous­ly re­ceived a pneu­mo­coc­cal vac­cine, or who had re­ceived par­tial or full reg­i­mens of an al­ready ap­proved PCV. Re­searchers re­port­ed that V114’s per­for­mance was “gen­er­al­ly com­pa­ra­ble” to Pre­vnar’s for the 13 serotypes they share. But for 22F and 33F, V114 boast­ed a high­er im­mune re­sponse.

In PNEU-DI­REC­TION, re­searchers stud­ied the in­ter­change­abil­i­ty of V114 and Pre­vnar 13 in 900 ba­bies be­tween 42 and 90 days old. Im­mune re­spons­es seen in ba­bies who had re­ceived a four-dose se­ries of Pre­vnar 13 were com­pa­ra­ble to those seen in ba­bies who got a mixed reg­i­men of Pre­vnar and V114 against the 13 shared serotypes.

The full re­sults are com­ing at a fu­ture sci­en­tif­ic con­gress, Mer­ck said.

“Re­sults from these stud­ies sup­port the po­ten­tial of V114 to con­fer im­muno­genic­i­ty for PCV13 serotypes in in­fants who have pre­vi­ous­ly re­ceived one or mul­ti­ple dos­es of PCV13, and for the 15 serotypes in V114 in chil­dren in a catch-up set­ting,” Baynes said.

It’s a tight race as reg­u­la­tors con­sid­er both V114 and a 20-va­lent can­di­date from Pfiz­er (Pre­vnar 20) in adults 18 years and up. The FDA plans on giv­ing Pfiz­er a de­ci­sion in June while Mer­ck’s PDU­FA date is Ju­ly 18.

Vax­cyte, for­mer­ly known as SutroVax, is in ear­ly de­vel­op­ment for a 24-strain can­di­date, which hopes to un­seat both Pfiz­er and Mer­ck. The com­pa­ny raised $249 mil­lion in an IPO last June and ex­pects to sub­mit an IND in the sec­ond half of this year.

Pre­vnar 13 raked in $5.8 bil­lion in 2020, and was once the world’s best-sell­ing vac­cine, in pre-Covid times.

On Jan. 11 — the same day the FDA ac­cept­ed a BLA for V114 — Mer­ck filed a law­suit chal­leng­ing three of Pfiz­er’s patents re­lat­ing to its pneu­mo­coc­cal con­ju­gate com­po­si­tions. The com­pa­ny has asked a judge to rule that V114 “does not and will not in­fringe any valid claim of these three patents.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Sanofi scraps PhI­II tri­al for Prin­cip­ia drug af­ter re­view­ing com­pe­ti­tion

Months after the FDA placed Phase III trials of Sanofi’s BTK inhibitor on hold, the company is winding down one of the studies.

Sanofi reported in its Q4 earnings that the URSA study “was discontinued after careful evaluation of the emerging competitive treatment landscape in” myasthenia gravis, a rare disease that causes muscle weakness.

The Phase III, placebo-controlled trial was testing tolebrutinib in patients with the moderate-to-severe form of the disease. It started in late 2021, according to records on clinicaltrials.gov, and was originally designed to recruit 154 participants who were receiving the standard of care.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

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The Big Phar­ma axe: Mer­ck cuts chikun­gun­ya vax, Bris­tol My­ers drops Cy­tomX-part­nered pro­gram, and more

As fourth quarter earnings come in, Big Pharmas are disclosing changes to their pipelines during their investor calls, and sometimes more quietly in presentation appendices.

Merck dropped its chikungunya vaccine candidate, which completed a Phase II study. Merck acquired the vaccine through its purchase of Themis Bioscience in 2020. In developing a vaccine for chikungunya, a mosquito-borne virus, Valneva is the frontrunner, as it submitted its vaccine to the FDA at the end of December.

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