Bill Gates (Leon Neal/Pool via AP Images)

Bill and Melin­da Gates Foun­da­tion backs lit­tle-known biotech go­ing af­ter Pfiz­er, Mer­ck on pneu­mo­coc­cal vac­cine

The Bill and Gates Melin­da Foun­da­tion has raised big mon­ey over its life­time to sup­port med­i­cines for poor­er coun­tries, and it an­nounced its lat­est in­vest­ment on Wednes­day.

In­vent­prise, a biotech lo­cat­ed in the Seat­tle sub­urbs, has se­cured a promise of up to $90 mil­lion from the non­prof­it, aimed at boost­ing de­vel­op­ment of its pneu­mo­coc­cal con­ju­gate vac­cine can­di­date, the Gates Foun­da­tion said Wednes­day morn­ing. The foun­da­tion ex­pects the cash will cov­er Phase I and Phase II stud­ies for the vac­cine, dubbed IVT-25.

The funds will help the start­up com­pete against two Big Phar­mas and some well-backed biotechs in the hunt for the best pneu­mo­coc­cal vac­cine. Mer­ck and Pfiz­er each won ap­proval for new pneu­mo­coc­cal shots this year, af­ter years of de­vel­op­ment. Mer­ck’s cov­ers 15 bac­te­r­i­al strains. Pfiz­er’s cov­ers 20 strains.

In­vent­prise is try­ing to build a shot that cov­ers 25 strains. That’s one more strain than the shot Vax­cyte, a biotech worth $1.3 bil­lion, is plan­ning on bring­ing in­to the clin­ic next year.

It can be a high­ly prof­itable fight. Pri­or to the ad­vent of the Covid-19 vac­cines, Pfiz­er’s pneu­mo­coc­cal shot Pre­vnar 13 was the most lu­cra­tive vac­cine on the plan­et.

Sub­hash Kapre

In­vent­prise, found­ed in 2012 by for­mer Serum In­sti­tute ex­ec­u­tive di­rec­tor Sub­hash Kapre, has worked with the Gates Foun­da­tion be­fore. Kapre used to be a con­sul­tant be­fore he found­ed In­vent­prise, and the foun­da­tion has fi­nan­cial­ly sup­port­ed dif­fer­ent vac­cine can­di­dates in In­vent­prise’s pipeline.

And since In­vent­prise was found­ed, it’s re­ceived close to $100 mil­lion in fund­ing from the Gates Foun­da­tion and oth­er sources— even be­fore to­day’s deal, com­pa­ny spokesper­son Bill Cad­wal­lad­er told End­points News. Some of Wednes­day’s funds will al­so go to­ward beef­ing up In­vent­prise’s man­u­fac­tur­ing ca­pa­bil­i­ties.

“I don’t re­al­ly con­sid­er us a start­up, but we’re a young com­pa­ny and most com­pa­nies out­source man­u­fac­tur­ing,” Cad­wal­lad­er said in an in­ter­view. “We will man­u­fac­ture our­selves and so we en­sure our own sup­ply chain.”

IVT-25 is still in the pre­clin­i­cal stage, but In­vent­prise said it plans to ad­vance it in­to the first hu­man tri­als in the sec­ond half of next year. Cad­wal­lad­er added that the start­up plans to have a Phase II, proof-of-con­cept study com­plet­ed by the end of 2023. If every­thing goes as planned, In­vent­prise will start Phase III tri­als in 2024 with the vac­cine po­ten­tial­ly ap­proved by 2025 or 2026.

The shot is de­signed to cov­er 25 dif­fer­ent strains of pneu­mo­coc­cal bac­te­ria, in­clud­ing those most preva­lent in African na­tions and oth­er poor coun­tries where the dis­ease af­fects young chil­dren.

“It is un­ac­cept­able that pneu­mo­nia re­mains the lead­ing cause of death among chil­dren un­der the age of five,” the foun­da­tion’s pneu­mo­nia pro­gram di­rec­tor Kei­th Klug­man said in a state­ment. “The sci­en­tif­ic com­mu­ni­ty must strive to de­vel­op more ef­fec­tive vac­cines to pro­tect the most vul­ner­a­ble chil­dren from more strains of this dev­as­tat­ing dis­ease.”

In­vent­prise says its goal is to cre­ate a glob­al fran­chise for pneu­mo­coc­cal con­ju­gate vac­cines, but it has sev­er­al oth­er shots in de­vel­op­ment. The biotech is al­so work­ing on vac­cines for menin­gi­tis, HPV, Covid-19, strep throat and oth­er in­fec­tious dis­eases.

Most of its pro­grams re­main in the dis­cov­ery stage; the 25-va­lent PCV shots for chil­dren and adults are the on­ly two in IND-en­abling stud­ies. In­vent­prise has al­so part­nered with Cana­da’s Na­tion­al Re­search Coun­cil to ad­vance de­vel­op­ment of some of these can­di­dates.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Bay­er starts work on $43M+ ex­pan­sion of OTC man­u­fac­tur­ing site in Penn­syl­va­nia

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.

US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).