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.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Watch out, Roche: No­var­tis inks $1.5B deal to chase down promi­nent Parkin­son’s tar­get

Novartis is plopping down $150 million in cash to pick up an experimental Parkinson’s drug and grab an option to another, a move that puts it on an increasingly popular path in the field’s search for disease-modifying therapies.

Belgium’s UCB is its partner of choice, supplying two small molecule alpha-synuclein misfolding inhibitors in a deal that can add up to nearly $1.5 billion.

Out of the pair, UCB0599 is already in Phase II trials, making Novartis confident enough to pull the trigger on co-development and commercialization, including to foot half of the R&D bill. The pharma giant will make a decision on UCB7853 once UCB wraps the ongoing Phase I program.

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Glax­o­SmithK­line, Ox­ford un­veil new part­ner­ship pit­ting buzzy R&D ad­vances against neu­ro­log­i­cal dis­ease

When GlaxoSmithKline trumpeted its return to neuroscience with a $700 million upfront deal with Alector this summer, it touted its early investments in functional genomics as a key guidepost for that deal. Now, the drug giant has partnered up with Oxford to hopefully add jet fuel to its hunt for breakthroughs in the brain.

GSK and Oxford have kickstarted a five-year collaboration aimed at spurring R&D breakthroughs across a range of hard-to-treat diseases like Alzheimer’s and Parkinson’s through the use of genomic testing and machine learning, the partners said Wednesday.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.