Covid-19 roundup: Pfiz­er li­cens­es its pill to the Med­i­cines Patent Pool; NYC joins states in au­tho­riz­ing boost­ers for all adults ahead of FDA

Fol­low­ing a sim­i­lar deal forged by Mer­ck for its Covid-19 drug mol­nupi­ravir, Pfiz­er on Tues­day agreed to al­low the UN-backed Med­i­cines Patent Pool to li­cense the com­pa­ny’s po­ten­tial treat­ment Paxlovid to make it more read­i­ly avail­able in 95 low- and mid­dle-in­come coun­tries.

The agree­ment al­lows MPP to grant sub-li­cens­es to qual­i­fied gener­ic drug man­u­fac­tur­ers to fa­cil­i­tate ad­di­tion­al pro­duc­tion and dis­tri­b­u­tion of the in­ves­ti­ga­tion­al an­tivi­ral, which has yet to be au­tho­rized.

Pfiz­er has not dis­closed a price for its treat­ment but ex­ec­u­tives have said they will price it sim­i­lar­ly to Mer­ck’s mol­nupi­ravir, which costs about $700 per treat­ment course in high-in­come coun­tries.

While the move to li­cense its drug, even be­fore its au­tho­riza­tion, may be viewed as a no­ble ef­fort, Doc­tors With­out Bor­ders said in a state­ment, “Li­cens­ing deals by phar­ma­ceu­ti­cal cor­po­ra­tions that cre­ate un­cer­tain­ties and seg­men­ta­tion for gener­ic pro­duc­tion and sup­ply con­tin­ue to be part of the prob­lem rather than part of a re­al so­lu­tion. There is no patent yet on the ex­per­i­men­tal can­di­date PF-07321332, and ri­ton­avir has been off patent since last year. In the ab­sence of patents on both com­pounds, able man­u­fac­tur­ers, par­tic­u­lar­ly those based in coun­tries ex­clud­ed from this li­cense, have an op­por­tu­ni­ty to ex­plore gener­ic pro­duc­tion di­rect­ly.”

NYC joins states in au­tho­riz­ing Covid-19 boost­ers for all adults ahead of FDA au­tho­riza­tion

New York City is join­ing Cal­i­for­nia, Col­orado, Arkansas, and New Mex­i­co in al­low­ing any adult to ac­cess a Covid-19 boost­er shot. Some, like car­di­ol­o­gist Er­ic Topol, called the de­ci­sion “ful­ly backed by the da­ta,” as Pfiz­er and BioN­Tech main­tain that the wan­ing im­mu­ni­ty from the ini­tial 2-dose se­ries needs the boost to get back in­to the 90%+ range for pro­tec­tion.

Oth­ers seem con­cerned that such a de­ci­sion isn’t nec­es­sar­i­ly backed by ro­bust da­ta, or that such dos­es should be shipped abroad as ini­tial dos­es. Oth­ers still ques­tion the need for states to over­ride the FDA’s de­ci­sion to on­ly au­tho­rize the boost­ers so far for cer­tain groups of peo­ple, in­clud­ing those old­er than 65.

The FDA, how­ev­er, wasn’t keen to dis­cuss the is­sue. An agency spokesper­son told End­points News to con­tact the CDC for as­sis­tance with any ques­tions, adding, “It is im­por­tant to note that FDA does not make im­mu­niza­tion or clin­i­cal rec­om­men­da­tions.”

On whether states should be au­tho­riz­ing boost­ers ahead of an FDA de­ci­sion for the same age group, or if this was more an is­sue of off-la­bel use (be­cause Pfiz­er’s vac­cine is FDA ap­proved), the agency spokesper­son said, “We do not have any­thing ad­di­tion­al to add to our pre­vi­ous re­sponse.”

Twist Bio­science re­veals an an­ti­body off­shoot with a start in Covid-19

Twist Bio­science un­veiled an off­shoot biotech this morn­ing — Rev­e­lar Bio­ther­a­peu­tics, which is work­ing on a po­ten­tial Covid-19 an­ti­body.

Ac­cord­ing to Twist, the in­de­pen­dent new biotech will be de­vel­op­ing and com­mer­cial­iz­ing an an­ti­body that has neu­tral­ized all known vari­ants of SARS-Cov-2 in pre­clin­i­cal tri­als.

That said, Rev­e­lar can lever­age Twist’s an­ti­body plat­form and li­cense ad­di­tion­al an­ti­bod­ies — up to five more tar­gets over the next four years, each of which will be sub­ject to ad­di­tion­al up­front, mile­stone and roy­al­ty pay­ments to Twist.

Twist CEO Emi­ly Lep­roust said in a state­ment that she hopes the an­ti­body will en­ter clin­i­cal stud­ies in 2022.

Twist is start­ing out with a $10 mil­lion seed in­vest­ment, based on Rev­e­lar’s de­vel­op­ment of the first an­ti­body and the po­ten­tial for suc­cess-based mile­stone pay­ments to­tal­ing over $100 mil­lion. In ex­change for the in­vest­ment and an­ti­body li­cens­ing, Twist got mi­nor­i­ty own­er­ship in Rev­e­lar — but at an un­spec­i­fied per­cent­age.

Rev­e­lar’s ex­ec­u­tive lead­er­ship team in­cludes Boehringer vet Glenn Ma­ri­na as CEO. Lep­roust and Twist CCO Patrick Finn are al­so part of the board of di­rec­tors.

“We look for­ward to com­plet­ing pre­clin­i­cal and CMC de­vel­op­ment in sup­port of fil­ing an IND,” said Ma­ri­na in a state­ment. — Paul Schloess­er

EU and EEA coun­tries agreed to do­nate 70+ mil­lion dos­es of Mod­er­na vax to low- and mid­dle-in­come coun­tries by year’s end

Mod­er­na to­day an­nounced an agree­ment that en­ables the EU and EEA coun­tries to do­nate dos­es of their Covid-19 vac­cine pur­chased un­der the EU Vac­cines Strat­e­gy to CO­V­AX for low and mid­dle-in­come coun­tries for the rest of the year.

The vac­cine dos­es will be head­ed to 92 coun­tries con­sid­ered as low- and mid­dle-in­come.

Ac­cord­ing to a Mod­er­na state­ment, the com­pa­ny ex­pects to see more than 70 mil­lion dos­es giv­en away by year’s end as part of the ini­tia­tive spear­head­ed by France, Swe­den and Nor­way. Ini­tial do­na­tions have in­clud­ed 15 mil­lion from France and 40 mil­lion from Ger­many.

“We be­lieve that dose shar­ing, among oth­er strate­gies, will help en­sure an eq­ui­table glob­al dis­tri­b­u­tion of COVID-19 vac­cines,” said Mod­er­na’s CEO Stéphane Ban­cel, who has come un­der fire re­cent­ly from the Biden ad­min­is­tra­tion for not help­ing enough on the in­ter­na­tion­al stage. — Paul Schloess­er

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.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

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.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Aim­ing for fourth nod, Sarep­ta files an­oth­er DMD gene ther­a­py to FDA; Ax­some head­ed to­ward mi­graine re­sub­mis­sion

Sarepta Therapeutics has filed the data needed for an FDA accelerated approval, which would be the biotech’s fourth if granted by the agency.

The biotech has yet to complete confirmatory trials for those first three conditional nods. The filing for its fourth Duchenne muscular dystrophy treatment, disclosed Thursday, is not a surprise. Sarepta said in late-July it would do so after releasing positive results for the Roche-partnered gene therapy.

Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.

Renhong Tang, Simcere co-CEO

Almi­rall part­ners up with Sim­cere in po­ten­tial $500M+ deal — with plans to take IL-2 can­di­date glob­al

A Chinese pharma is looking to go international with one of its preclinical candidates, and it’s teaming up with a Spanish company in a new pact potentially worth half a billion dollars to do just that.

Simcere and Almirall announced Thursday that the two companies had reached a deal for Simcere’s IL-2 mutant fusion protein drug candidate, called SIM0278. According to a statement, Almirall gets an exclusive right to develop and commercialize the drug candidate in all indications and markets outside of China, Hong Kong, Taiwan and Macau.

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