Af­ter near­ly two years of crit­i­cism from ac­tivists and White House, Mod­er­na un­veils a new plan for glob­al health

Mod­er­na, the tar­get of near­ly two years of crit­i­cism for its poli­cies around glob­al ac­cess to its Covid-19 vac­cine, an­nounced on Mon­day a new plan to ad­dress glob­al health.

The mR­NA biotech said it would launch a four-part pro­gram. First, it would put vac­cines in­to clin­i­cal test­ing for 15 pathogens that could ei­ther cause fu­ture pan­demics, such as Ni­pah virus or Zi­ka, or that pri­mar­i­ly af­fect the de­vel­op­ing world, such as tu­ber­cu­lo­sis and malar­ia.

Sec­ond, it would start a pro­gram called mR­NA Ac­cess to give re­searchers around the globe tools to man­u­fac­ture mR­NA for lab and an­i­mal stud­ies. And it will se­lect a site in Kenya for its planned African mR­NA man­u­fac­tur­ing plant, an­nounced ear­li­er to­day, which the com­pa­ny had pre­vi­ous­ly said would on­ly be some­where on the con­ti­nent.

Last­ly, Mod­er­na an­nounced that, for 92 low and mid­dle-in­come coun­tries, it will nev­er en­force its patents on its Covid-19 vac­cines, ex­tend­ing a lim­it­ed ver­sion of a promise it had made at the be­gin­ning of the pan­dem­ic.

“We must not as­sume that the COVID-19 pan­dem­ic will be the last pan­dem­ic that will im­pact glob­al health,” said CEO Stéphane Ban­cel. “Since our be­gin­ning, we have fo­cused on de­vel­op­ing a glob­al health vac­cine pro­gram and to­day, we are re­new­ing that fo­cus.”

The new moves come af­ter more than a year of crit­i­cism, ini­tial­ly from ac­tivists and NGOs but most re­cent­ly from the Biden White House, that Mod­er­na was not do­ing enough to make its high­ly ef­fec­tive Covid-19 vac­cine avail­able around the globe.

Some of those same ac­tivists wel­come Mod­er­na’s new moves, even if it didn’t go quite far enough in in­creas­ing im­me­di­ate vac­cine ac­cess.

James Love

“The promis­es they made — to me, they seem mean­ing­ful,” said James Love, di­rec­tor of Knowl­edge Ecol­o­gy In­ter­na­tion­al. “They’re clear­ly pres­sured by the White House and pressed by ac­tivists and oth­er peo­ple to do more than they’re do­ing.”

While As­traZeneca and J&J pri­or­i­tized low and mid­dle-in­come coun­tries with their shot, Mod­er­na ini­tial­ly sold the vast ma­jor­i­ty of its vac­cines to the US and oth­er wealthy na­tions.

Al­though it even­tu­al­ly pledged 500 mil­lion dos­es to Co­v­ax, the UN-backed body for eq­ui­tably dis­trib­ut­ing vac­cines, the biotech re­sist­ed calls to trans­fer its mR­NA tech­nol­o­gy to man­u­fac­tur­ing plants in oth­er parts of the globe that ac­tivists said might be able to pro­duce more shots.

Mod­er­na ex­ec­u­tives said they were a small biotech that didn’t nec­es­sar­i­ly have the staff to con­duct such com­plex trans­fers while al­so scal­ing up fa­cil­i­ties in the US and Eu­rope.  That ar­gu­ment had some trac­tion with vac­cine man­u­fac­tur­ing ex­perts but Politi­co re­port­ed that Biden ad­min­is­tra­tion of­fi­cials be­lieved Mod­er­na was more con­cerned with its bot­tom line: Com­pa­nies gen­er­al­ly sell vac­cines at cost in poor­er na­tions, rather than at a prof­it.

Mod­er­na’s new an­nounce­ment al­so elides an easy an­swer on the most high-pro­file ef­fort to scale up Mod­er­na’s vac­cine around the world. A WHO-backed team in South Africa has worked to re­verse-en­gi­neer the com­pa­ny’s shot to cre­ate a free and scal­able ver­sion.

Its di­rec­tor has said it would take one to two years with Mod­er­na’s help, but three to four years with­out it. And the le­gal sta­tus of the ef­fort was un­clear, giv­en that Mod­er­na had promised to not en­force its patents dur­ing the pan­dem­ic and Ban­cel had hint­ed the com­pa­ny may soon change its pos­ture.

Pe­ter May­bar­duk

Ac­tivists not­ed that al­though Mod­er­na’s new pledge in­cludes a promise to not en­force patents in 92 coun­tries, it does not in­clude South Africa, where the WHO ef­fort is un­der­way. And to the con­trary, Mod­er­na’s new state­ment says it ex­pects coun­tries out­side those 92 to “re­spect the Com­pa­ny’s in­tel­lec­tu­al prop­er­ty”

How­ev­er, Pe­ter May­bar­duk of Pub­lic Cit­i­zen said his un­der­stand­ing is that Mod­er­na will not stop pro­duc­tion of the WHO-backed vac­cine in South Africa. It will sim­ply stop them from sell­ing it there.

“It’s good,” he said. “Mod­er­na is step­ping out of the way as an ob­sta­cle.”

But lim­it­ing the mar­ket for the WHO ef­fort will al­so lim­it the com­mer­cial vi­a­bil­i­ty of any com­pa­ny that wants to man­u­fac­ture the re­verse-en­gi­neered shot, he said, po­ten­tial­ly un­der­min­ing the ef­fort.

”Mod­er­na still has not done what is most need­ed,” May­bar­duk said. That, he said, would be to ac­tive­ly help trans­fer its tech­nol­o­gy to the WHO and sci­en­tists in South Africa. “In­stead, we have Mod­er­na carv­ing up a map and try­ing to de­cide who can co­op­er­ate with who.”

Love not­ed that the 92 coun­tries al­so do not in­clude large swaths of Asia and Latin Amer­i­ca.

“It’s a rel­a­tive­ly con­ser­v­a­tive area for them,” he said.

Mod­er­na did not re­spond to ques­tions about how its new pol­i­cy will af­fect the South African ef­fort.

Mod­er­na’s new strat­e­gy in­cludes mul­ti­ple li­cens­ing plans, but nei­ther seems to cov­er them. The com­pa­ny said it would li­cense to oth­er man­u­fac­tur­ers as it be­gins fo­cus­ing on de­vel­op­ing new vac­cines, but on­ly “on com­mer­cial­ly rea­son­able terms.” And the mR­NA Ac­cess pro­gram on­ly cov­ers pre­clin­i­cal de­vel­op­ment — a stage where many re­searchers, al­though far from all, al­ready have ca­pa­bil­i­ties.

The new plant in Africa, which Mod­er­na ex­pects to even­tu­al­ly pro­duce 500 mil­lion dos­es of vac­cine per year, stands in con­trast to a BioN­Tech plan un­veiled last month. The Ger­man com­pa­ny said it would sup­ply ca­pac­i­ty in Africa by de­vel­op­ing portable fac­to­ries that can be built in Eu­rope and shipped to dif­fer­ent re­gions around the globe.

The plan to de­vel­op new vac­cines for po­ten­tial pathogens mir­rors calls from the NIH and oth­er groups to de­vel­op pro­to­type shots to guard against fu­ture pan­demics. In malar­ia and tu­ber­cu­lo­sis, Mod­er­na’s new ef­forts will com­pete against mR­NA shots al­ready in de­vel­op­ment from BioN­Tech.

Zachary Bren­nan con­tributed re­port­ing

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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