With piv­otal da­ta on its Covid-19 an­ti­body in hand, As­traZeneca pre­pares for a mad dash to the FDA

A month af­ter re­veal­ing that its mon­o­clon­al an­ti­body com­bi­na­tion was 77% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19 com­pared to place­bo, As­traZeneca says it’s head­ed to the FDA.

“We’ve cer­tain­ly shared the da­ta with reg­u­la­tors, and we an­tic­i­pate sub­mit­ting the emer­gency use au­tho­riza­tion very short­ly,” Mark Ess­er, VP and head of mi­cro­bial sci­ences and bio­phar­ma­ceu­ti­cals R&D, said dur­ing a press con­fer­ence on Wednes­day af­ter­noon.

Just eight of 3,460 vol­un­teers giv­en AZD7442 in the Phase III PROVENT tri­al came down with symp­to­matic Covid-19 over a six-month pe­ri­od, Ess­er said, com­pared to 17 of 1,737 peo­ple in the place­bo group.

The study en­rolled par­tic­i­pants across the US, UK, Spain, France and Bel­gium, many of whom had co­mor­bidi­ties or oth­er con­di­tions that would cause a re­duced im­mune re­sponse to vac­ci­na­tion. That in­clud­ed peo­ple on im­muno­sup­pres­sive drugs, or with dis­eases like di­a­betes, smok­ing-re­lat­ed lung dis­ease, kid­ney dis­ease, and chron­ic liv­er dis­ease, among oth­ers.

Over­all, the ther­a­py post­ed a 77% ef­fi­ca­cy rate — a sig­nif­i­cant­ly high­er rate than the 63% ef­fi­ca­cy re­port­ed to the WHO for the com­pa­ny’s own Covid-19 vac­cine. At an in­ter­im read­out in March, As­traZeneca had re­port­ed that its vac­cine was 70% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19, which was slight­ly high­er than the 62% fig­ure post­ed in the UK.

There were no se­vere cas­es or deaths in the AZD7442 treat­ment arm, and three se­vere cas­es and two deaths in the place­bo arm, the phar­ma said. Though it’s un­clear how the FDA may view the tri­al’s rel­a­tive­ly small sam­ple size.

De­spite the pos­i­tive ef­fi­ca­cy re­sults, Ess­er stressed that AZD7442 is in­tend­ed for use on top of vac­ci­na­tion, not in lieu of it.

Mark Ess­er

“First and fore­most, we want peo­ple to get vac­ci­nat­ed. We know the vac­cines work in most peo­ple,” he said. “Now, if there is some­one who’s had an al­ler­gic re­ac­tion to one of the vac­cines, or for some rea­son can­not get vac­ci­nat­ed, I think 7442 could be a so­lu­tion for that.”

AZD7442 was dis­cov­ered by the Van­der­bilt Uni­ver­si­ty Med­ical Cen­ter, and li­censed to As­traZeneca last June. It’s a com­bi­na­tion of the an­ti­bod­ies tix­agevimab and cil­gav­imab, de­rived from B cells do­nat­ed by a hus­band and wife team who had re­cov­ered from Covid-19. The ben­e­fit of a mon­o­clon­al an­ti­body is that it pro­vides “al­most im­me­di­ate” pro­tec­tion, where­as cur­rent vac­cines ap­proved in the US take a cou­ple weeks to kick in.

The down­side is that the du­ra­tion of pro­tec­tion is much short­er. As­traZeneca says it has tech­nol­o­gy that can ex­tend the an­ti­body’s half life from an av­er­age of around 20 days to 90 days.

“What this means is that a sin­gle in­tra­mus­cu­lar shot could eas­i­ly af­ford six months, and we’re hope­ful up to 12 months of pro­tec­tion,” Ess­er said on the call.

In ad­di­tion to PROVENT, AZD7442 is al­so in the on­go­ing TACK­LE COVID-19 pro­gram, which looks at the an­ti­bod­ies’ abil­i­ty to treat and pre­vent Covid across more than 9,000 par­tic­i­pants in the out­pa­tient set­ting. And while vol­un­teers got the can­di­date in­ject­ed in­to the mus­cle in PROVENT, it’s al­so be­ing as­sessed as an IV drug.

Back in June, AZD7442 missed the mark in a study as­sess­ing its abil­i­ty to pre­vent symp­toms in adults who had a con­firmed ex­po­sure to Covid-19. As­traZeneca says the an­ti­body com­bo per­formed bet­ter in a pre-planned analy­sis of PCR-neg­a­tive vol­un­teers.

Ess­er says he’s “quite con­fi­dent” AZD7442 will work against the Delta vari­ant, as well as oth­er emerg­ing vari­ants, adding that there were few Delta cas­es re­port­ed in the treat­ment arm, and many in the place­bo arm. He said the com­pa­ny is se­quenc­ing the virus­es, and will have more da­ta to share soon.

Hugh Mont­gomery, a pro­fes­sor of med­i­cine and di­rec­tor of the Cen­tre for Hu­man Health and Per­for­mance at Uni­ver­si­ty Col­lege in Lon­don, point­ed to the ben­e­fit of hav­ing two long-act­ing an­ti­bod­ies.

“If one was look­ing at the risk of vi­ral es­cape down the line, the chances of get­ting two mu­ta­tions to pre­vent these an­ti­bod­ies bind­ing would be very, very un­like­ly,” Mont­gomery said.

The news comes a month af­ter fed­er­al of­fi­cials reau­tho­rized Eli Lil­ly’s an­ti­body com­bo, which had been tak­en off the mar­ket due to a “sus­tained in­crease” of coro­n­avirus vari­ants in the US. That com­bo — bam­lanivimab and ete­se­vimab — is now au­tho­rized in states where the fre­quen­cy of re­sis­tant vari­ants like the Delta-plus or Gam­ma is 5% or low­er.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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