Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

As con­ti­nen­t's vac­ci­na­tion rate sits be­low 5%, Mod­er­na an­nounces in­vest­ment in mR­NA man­u­fac­tur­ing in Africa

Af­ter mount­ing pres­sure from com­peti­tors, Mod­er­na has signed on to in­vest $500 mil­lion in an mR­NA man­u­fac­tur­ing site in Africa that could make up to 500 mil­lion dos­es a year.

It’s a move in­to a re­gion that has been large­ly ne­glect­ed his­tor­i­cal­ly by Big Phar­ma, a trend that’s held strong through­out the Covid-19 pan­dem­ic. The Mo­roc­can gov­ern­ment re­cent­ly dropped $500 mil­lion in­to a new Re­ci­pharm fill-fin­ish plant, and Gri­fols is build­ing an IV bag plant in Nige­ria, but those projects aren’t set to be up and run­ning un­til 2023 and 2024, re­spec­tive­ly.

Just about 4.4% of all Africans have been ful­ly vac­ci­nat­ed for Covid-10, ac­cord­ing to the World Health Or­ga­ni­za­tion.

The site will pro­duce up to 500 mil­lion dos­es at the 50 µg dose lev­el, and the fa­cil­i­ty will in­clude drug sub­stance man­u­fac­tur­ing on top of fill-fin­ish and pack­ag­ing ca­pa­bil­i­ties. Mod­er­na will next have to fo­cus on se­lect­ing a site for the fa­cil­i­ty. This fits in to Mod­er­na’s re­cent­ly an­nounced rapid ramp-up strat­e­gy.

“On be­half of our grow­ing team, part­ners and share­hold­ers, we are de­ter­mined to ex­tend Mod­er­na’s so­ci­etal im­pact through the in­vest­ment in a state-of-the-art mR­NA man­u­fac­tur­ing fa­cil­i­ty in Africa,” CEO Stéphane Ban­cel said in a press re­lease Thurs­day. “While we are still work­ing to in­crease ca­pac­i­ty in our cur­rent net­work to de­liv­er vac­cines for the on­go­ing pan­dem­ic in 2022, we be­lieve it is im­por­tant to in­vest in the fu­ture. We ex­pect to man­u­fac­ture our COVID-19 vac­cine as well as ad­di­tion­al prod­ucts with­in our mR­NA vac­cine port­fo­lio at this fa­cil­i­ty.”

The move comes as Mod­er­na has re­sist­ed pres­sure from the White House to up pro­duc­tion and do­na­tions of the Covid-19 shot. Pres­i­dent Joe Biden’s ad­min­is­tra­tion has urged Mod­er­na for months to up pro­duc­tion do­mes­ti­cal­ly, and at least one of­fi­cial told Politi­co that it be­lieves that the re­luc­tance has been dri­ven by the threat of sell­ing the jabs at-cost.

The US gov­ern­ment dumped $200 mil­lion over the sum­mer in­to a South African plant to en­sure that Africans had ac­cess to J&J’s vac­cines. But in Au­gust, The New York Times re­port­ed that many of those dos­es had been ex­port­ed back to Eu­rope. At that time, just 2% of Africans were vac­ci­nat­ed, com­pared to more than 60% of adults in Eu­rope. J&J’s jab was par­tic­u­lar­ly cru­cial in Africa be­cause it’s a sin­gle shot, mak­ing it eas­i­er for peo­ple in rur­al ar­eas to get ful­ly in­oc­u­lat­ed.

The African Union has or­dered 400 mil­lion dos­es of vac­cines for the coun­tries with­in it, but few have been de­liv­ered.

The an­nounce­ment comes months af­ter BioN­Tech, its big com­peti­tor in the mR­NA space, an­nounced it would piv­ot the fo­cus of its new man­u­fac­tur­ing sites in Africa from Covid-19 treat­ments to malar­ia when the time be­came right, and a day af­ter the WHO ap­proved Glax­o­SmithK­line’s malar­ia vac­cine.

The com­pa­ny’s pipeline has 20 vac­cine can­di­dates, in­clud­ing a BAR­DA-fund­ed Zi­ka vac­cine that is in Phase II, a com­bi­na­tion Covid-19 and flu vac­cine and an HIV jab that is cur­rent­ly in pre­clin­i­cal de­vel­op­ment.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Bo Cumbo, new Solid Bio CEO

Sol­id Bio gets a new CEO, $75M cash and drops lead drug as big in­vestors ju­ry-rig a merg­er deal

Three months after Endpoints News broke the story that gene therapy outfit AavantiBio had gutted its CMC group in a reorganization, the biotech’s CEO has helped engineer a merger with struggling penny stock player Solid Bio. And he’s going to remain in charge of the combined operation, as Solid founder Ilan Ganot steps aside.

The merger news this morning features some high-profile investors.

Perceptive Advisors, RA Capital Management and Bain Capital Life Sciences are leading a $75 million raise to add to the pool of cash Solid will have after the tie-up. That will leave Solid $215 million in cash as Bain’s Adam Koppel jumps on the board — enough to pay for ops and get through some key data milestones on their way into 2025.

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Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Elisabeth Stampa, Medicines for Europe president

As win­ter ap­proach­es, a Eu­ro­pean gener­ics group rais­es alarm over en­er­gy prices for man­u­fac­tur­ers

While colder temperatures are fast approaching, the situation surrounding the rise of energy prices in Europe is hitting businesses of every kind, including generic drug manufacturers.

Medicines for Europe, a group that represents the generic industry on the continent, sent a letter addressed to energy ministers and commissioners concerning inflation and the costs of energy on the supply of generic medicines.