A mus­cled up Mod­er­na fi­nal­ly joins the CO­V­AX crew, pledg­ing 500M dos­es for low-in­come coun­tries

Days af­ter tur­bocharg­ing its Covid-19 vac­cine man­u­fac­tur­ing ca­pac­i­ty to the tune of 3 bil­lion dos­es per year, Mod­er­na an­nounced Mon­day it has struck a deal with Gavi, the vac­cine al­liance, to sup­ply up to 500 mil­lion dos­es of its shot to the low­est in­come coun­tries by the end of next year.

The dis­cus­sions date back at least to last Oc­to­ber, when Mod­er­na told in­vestors about on­go­ing dis­cus­sions with CO­V­AX “on a tiered pric­ing pro­pos­al for pur­chas­ing mR­NA-1273.”

All dos­es will be sold at the “low­est tiered price,” ac­cord­ing to the Cam­bridge, MA-based biotech, and be dis­trib­uted among 92 coun­tries.

Un­der the fi­nal agree­ment, Mod­er­na will be­gin de­liv­ery of 34 mil­lion dos­es in Q4 of 2021, while the CO­V­AX fa­cil­i­ty — spear­head­ed by Gavi, WHO and CEPI — has an op­tion to pro­cure the re­main­ing 466 mil­lion dos­es fol­low­ing those ini­tial ship­ments.

CEPI, the Nor­way-based group ded­i­cat­ed to fund­ing epi­dem­ic pre­pared­ness, had giv­en Mod­er­na a $900,000 grant back in Jan­u­ary 2020. The WHO, mean­while, had just added mR­NA-1273 — which was shown to be about 95% ef­fec­tive in Phase III tri­als and con­tin­ues to of­fer de­cent pro­tec­tion against vari­ants in re­al world set­tings — to the list of vac­cines it rec­om­mends for emer­gency use against Covid-19.

With shots from Pfiz­er, As­traZeneca and the Serum In­sti­tute of In­dia in its port­fo­lio, CO­V­AX has so far shipped over 49 mil­lion Covid-19 vac­cines. The largest donor, though, is No­vavax, which has agreed to sup­ply 1.1 bil­lion dos­es of its yet-to-be-ap­proved pro­tein-based jab.

“Ex­pand­ing and hav­ing a di­verse port­fo­lio has al­ways been a core goal for CO­V­AX, and to re­main adapt­able in the face of this con­tin­u­al­ly evolv­ing pan­dem­ic – in­clud­ing the ris­ing threat posed by new vari­ants,” Gavi chief Seth Berkley said in a state­ment.

In a re­cent in­ter­view with End­points News, Mod­er­na CEO Stéphane Ban­cel de­scribed their ex­pand­ed pro­duc­tion com­mit­ment as a “mas­sive in­vest­ment” aimed at vac­ci­nat­ing and boost­ing pop­u­la­tions around the world.

“We said look, we have a cer­tain re­spon­si­bil­i­ty as a com­pa­ny and we will in­vest ag­gres­sive­ly … so that next year we can have a big im­pact,” Ban­cel said. “If you think about it, look at the pop­u­la­tion of the plan­et, you see that 70% of peo­ple want the vac­cine, which is what we’re see­ing in polls across the world, and if we can make 3 bil­lion vac­cines, that will be, for a com­pa­ny that just launched its first prod­uct a few months ago, ex­tra­or­di­nary.”

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Luke Miels, GSK chief commercial officer

Lend­ing a hand to a biotech in trou­ble, GSK drops $75M cash to add late-stage an­tibi­ot­ic to port­fo­lio

GSK likes to take pride in being one of the few Big Pharma players still active in antibiotics R&D. And that means keeping tabs on what the field has to offer.

In a move to beef up the late-stage pipeline, GSK is licensing a late-stage antibiotic candidate from Spero Therapeutics. In doing so, it’s coming to the rescue of a struggling biotech that’s crumbled in the wake of an FDA rejection and raised doubts about its ability to carry on.

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David Chang, Allogene CEO (Jeff Rumans)

Servi­er cuts off col­lab­o­ra­tion agree­ment with Al­lo­gene on CD19 prod­ucts, send­ing shares sput­ter­ing

Allogene Therapeutics said in an SEC filing today that French partner Servier has cut off its involvement in a partnership developing therapies directed against CD19, including the most advanced candidates in Allogene’s pipeline.

Shares of Allogene $ALLO, an outfit run by Kite vets Arie Belldegrun and research chief David Chang, fell by almost 10% on Wednesday, even as the San Francisco-based company said that Servier’s discontinuation “does not otherwise affect our current exclusive license for the development and commercialization of CD19 Products in the United States.”

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.