Covid-19 man­u­fac­tur­ing roundup: FDA frees up more Emer­gent vac­cine dos­es; Pfiz­er and Viet­nam dis­cuss tech trans­fer — re­port

The FDA has freed up yet an­oth­er batch of J&J Covid-19 vac­cines that were held up due to con­t­a­m­i­na­tion at Emer­gent’s Bal­ti­more Bayview plant.

In a let­ter ad­dressed to J&J’s North Amer­i­can Reg­u­la­to­ry leader Ru­ta Walawalkar, the agency re-is­sued emer­gency use au­tho­riza­tion to one more batch on Ju­ly 13. That will free up an­oth­er 10 mil­lion dos­es Bloomberg re­ports.

“I am waiv­ing Cur­rent Good Man­u­fac­tur­ing Prac­tice re­quire­ments for this batch, and on­ly this batch, for the du­ra­tion of this EUA,” the let­ter, signed by di­rec­tor of vac­cines and re­search Mar­i­on Gru­ber, says. “This con­cur­rence does not add any oth­er batch­es man­u­fac­tured at this fa­cil­i­ty to the EUA at this time and does not add the fa­cil­i­ty it­self to the EUA at this time, nor does the EUA cov­er vac­cine man­u­fac­tured by com­bin­ing this batch with dif­fer­ent batch­es of drug sub­stance that are not au­tho­rized ex­plic­it­ly un­der this EUA.”

That marks the fifth batch of drug sub­stance that has been freed up af­ter a mishap that led to 75 mil­lion to­tal dos­es be­ing de­stroyed and tens of mil­lions more held back for test­ing. This brings the num­ber of J&J batch­es re­leased to about 50 mil­lion.

A batch of the vac­cine dos­es cleared last week had not yet been bot­tled, The New York Times re­port­ed, and US Pres­i­dent Joe Biden’s ad­min­is­tra­tion has not yet re­vealed what it will do with the dos­es. They could be head­ed else­where, as the US has just pledged 1 mil­lion dos­es of J&J’s jab to Bo­livia by Thurs­day, ac­cord­ing to CNN.

Pfiz­er and Viet­nam dis­cuss tech trans­fer: re­port

As Viet­nam sees a record num­ber of new Covid-19 in­fec­tions, the coun­try’s gov­ern­ment says it’s in talks with Pfiz­er about the pos­si­bil­i­ty of a tech­nol­o­gy trans­fer or open­ing a Pfiz­er plant, Reuters re­port­ed Wednes­day.

In June, the coun­try’s health min­istry said a lo­cal com­pa­ny was lined up to man­u­fac­ture the jab af­ter a trans­fer deal was ne­go­ti­at­ed with “an uniden­ti­fied US part­ner.” It did hint that the vac­cine would be mR­NA based and Pfiz­er’s vac­cine is ap­proved for use in the coun­try, along with Chi­na’s Sinopharm and As­traZeneca’s jab.

The coun­try had suc­cess­ful­ly staved off the virus for much of the pan­dem­ic, but since April, has bat­tled a stub­born out­break, which has ap­plied pres­sure on its gov­ern­ment to ramp up its vac­cine in­oc­u­la­tion. Few­er than 300,000 peo­ple in the coun­try have got­ten the shot, Reuters said.

Over 90% of the coun­try’s cas­es have been re­port­ed since May.

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.

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

BREAK­ING: 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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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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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.

FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

As the Office of Tissue and Advanced Therapies (OTAT) transforms into the Office of Therapeutic Products (OTP), with new user fee funds and “super office” status, the department focused on cell and gene therapies also opened its doors to a town hall Thursday offering clarification on guidance and regulations for manufacturers.

Some of the major concerns from manufacturers were the CMC considerations between first-in-human studies and late-phase studies supporting a marketing approval.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

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.

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.

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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