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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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CEO Lex Rovner (64x Bio)

A George Church spin­out fight­ing the vi­ral vec­tor bot­tle­neck in cell and gene ther­a­py lands $55M

A synthetic biology company spun out of George Church’s lab is set to tackle the gene therapy manufacturing bottleneck, and it just landed $55 million in a Series A financing round to do so.

64x Bio comes out of the Harvard Department of Genetics. CEO Lex Rovner and her team — which right now, sits around 10 people — are looking to tackle a key hurdle for major companies: manufacturing cell and gene therapies.