First the US, now the EU: Pfiz­er’s 20-va­lent pneu­mo­coc­cal jab for in­fants head­ed to reg­u­la­tors 

About five weeks af­ter Pfiz­er said its 20-va­lent vac­cine fol­low-up to Pre­vnar 13 was ef­fec­tive in in­fants in a US study, the Big Phar­ma now has the da­ta from an EU late-stage tri­al that will send the jab to the con­ti­nent’s reg­u­la­tors by year’s end.

Both the US and Eu­ro­pean Med­i­cines Agency are ex­pect­ed to have the fil­ings in hand for 20vP­nC for in­fants be­fore the first ba­bies of 2023 are born. The US green­lit the vac­cine, known as Pre­vnar 20, for adults in June 2021, and for the same pop­u­la­tion in the EU, where it’s known as Apexxnar, on Valen­tine’s Day of this year.

The da­ta come in three months af­ter ri­val Mer­ck se­cured the FDA ap­proval for the 15-va­lent Vaxneu­vance for kids.

In a study of 1,258 in­fants in Eu­rope and Aus­tralia, be­tween Sep­tem­ber 2020 and April 2022, Pfiz­er’s three-dose vac­cine se­ries showed that it led to “long-term pro­tec­tion,” Pfiz­er said Mon­day morn­ing. Re­searchers in­oc­u­lat­ed in­fants at 2, 4 and 11-12 months of age and com­pared the vac­cine to Pre­ve­nar 13.

Re­searchers looked at three key out­comes, in­clud­ing non-in­fe­ri­or­i­ty of im­munoglob­u­lin G, or IgG, geo­met­ric mean con­cen­tra­tions four weeks af­ter the third dose. Of the 20 serotypes, 19 met that end­point, Pfiz­er said.

SVB Se­cu­ri­ties an­a­lysts said the re­sults “should fur­ther sup­port” the vac­cine’s pro­file in doc­u­ments shipped to reg­u­la­tors.

“Re­call that in the US study, on­ly 14/20 STs met NI on this end­point which we saw as con­cern­ing be­cause it im­plied PFE’s 20-va­lent vac­cine didn’t match (cross-tri­al) MRK’s (OP) 15-va­lent Vaxneu­vance ef­fi­ca­cy in chil­dren,” SVB Se­cu­ri­ties an­a­lysts wrote in a note short­ly af­ter the da­ta drop.

The US study test­ed four dos­es. Re­gard­ing the dif­fer­ences in num­ber of shots be­tween the two re­gions, Pfiz­er said in an email to End­points News that Eu­rope’s reg­u­la­tors’ im­mu­niza­tion sched­ule looks at two in­fant dos­es and one tod­dler dose for pneu­mo­coc­cal con­ju­gate vac­cines. How­ev­er, the rec­om­men­da­tion for some vul­ner­a­ble in­fants re­mains four over­all dos­es, de­pend­ing on the coun­try, the spokesper­son said. The four dose se­ries in the US re­flects the FDA and ACIP rec­om­mend­ed sched­ule, they added.

The study al­so looked at the same met­ric at an ear­li­er point: one month af­ter the sec­ond dose. Six­teen of the 20 serotypes met non-in­fe­ri­or­i­ty. And on the fi­nal co-pri­ma­ry out­come — the non-in­fe­ri­or­i­ty of the per­cent­age of pa­tients with pre­de­fined serotype-spe­cif­ic IgG con­cen­tra­tions one month af­ter dose 2 — nine of the 20 serotypes met the NI cri­te­ria.

“Strong func­tion­al an­ti­body re­spons­es” were seen across all 20 vac­cine serotypes, sim­i­lar to that seen with the first two it­er­a­tions of Pre­ve­nar, Pfiz­er said. Boost­er re­spons­es al­so in­creased af­ter dos­es 2 and 3.

An­naliesa An­der­son

“Based on the to­tal­i­ty of im­muno­genic­i­ty and safe­ty da­ta, we feel con­fi­dent that 20vP­nC is like­ly to be pro­tec­tive against all vac­cine serotypes in a three-dose se­ries,” said An­naliesa An­der­son, Pfiz­er CSO for vac­cines R&D and SVP, in a state­ment.

Safe­ty find­ings came in “sim­i­lar to Pre­ve­nar 13,” Pfiz­er said. “Con­comi­tant use with com­mon pe­di­atric vac­cines were sup­port­ed.” De­tailed safe­ty and im­muno­genic­i­ty da­ta will be pre­sent­ed “at a fu­ture date,” once the analy­sis has wrapped up.

The goal is to pre­vent pneu­mo­coc­cal bac­te­ria from spurring pneu­mo­nia, in­va­sive pneu­mo­coc­cal dis­ease and acute oti­tis me­dia so that long-term neu­ro­log­i­cal dam­age doesn’t oc­cur.

Pfiz­er and Mer­ck have long been ri­vals in the pneu­mo­coc­cal vac­cine space. Mer­ck had a 23-va­lent jab ap­proved back in the 1980s, but the pneu­mo­coc­cal poly­sac­cha­ride vac­cine’s ef­fi­ca­cy didn’t hold up in younger chil­dren, so sci­en­tists shift­ed to con­ju­gat­ed vac­cines.

Mer­ck pre­vi­ous­ly agreed to pay Pfiz­er a small per­cent­age of net sales on all pneu­mo­coc­cal con­ju­gate vac­cine shots through 2035.

Ed­i­tor’s note: This sto­ry was up­dat­ed to in­clude in­for­ma­tion from a Pfiz­er spokesper­son. 

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

Andrew Crockett, KalVista CEO

KalVista ends a PhII study ear­ly af­ter pa­tients suf­fer se­vere and life-threat­en­ing side ef­fects

KalVista took a beating Tuesday after announcing it would scrap a Phase II trial for one of its experimental drugs.

The biotech said in an early morning press release that it is terminating the study for KVD824 after multiple patients in every treatment group saw unsafe, elevated levels of certain liver enzymes. By ending the trial now, KalVista hopes to save some money and funnel it toward another study for its lead program, CEO Andrew Crockett said in a statement.

Pen­ny stock play­er to re­view all op­tions to try stay­ing afloat af­ter clin­i­cal tri­al fail

Adamis Pharmaceuticals is slowly tumbling down, and the biotech is looking at all its options.

After a Phase II/III trial failure last month that sent the penny stock player down an additional 50% to just 15 cents a share, the company said Monday that it is examining options to get the best value for its investors. A statement from Adamis indicates that alternatives include anything from a partnership to a sale of Adamis’ two commercial products, Zimhi and Symjepi.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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