As­traZeneca pub­lish­es Covid-19 vac­cine PhI­II pro­to­cols in lock­step with Mod­er­na and Pfiz­er. How are they dif­fer­ent?

Fol­low­ing in the steps of Mod­er­na and Pfiz­er, the oth­er two Amer­i­can drug­mak­ers cur­rent­ly in Phase III tri­als for their Covid-19 vac­cines, As­traZeneca post­ed its own study pro­to­cols over the week­end. The move is the lat­est in a se­ries of rare peeks be­hind the cur­tain, as such blue­prints are typ­i­cal­ly shared once such tri­als are com­plet­ed.

“Giv­en the un­prece­dent­ed glob­al im­pact of the Coro­n­avirus pan­dem­ic and the need for pub­lic in­for­ma­tion, As­traZeneca has pub­lished the de­tailed pro­to­col and de­sign of our AZD1222 clin­i­cal tri­al. As with most clin­i­cal de­vel­op­ment, pro­to­cols are not typ­i­cal­ly shared pub­licly due to the im­por­tance of main­tain­ing con­fi­den­tial­i­ty and in­tegri­ty of tri­als. As­traZeneca con­tin­ues to work with in­dus­try peers to en­sure a con­sis­tent ap­proach to shar­ing time­ly clin­i­cal tri­al in­for­ma­tion,” the com­pa­ny said in a state­ment.

As­traZeneca’s tri­al, un­like the ones from coun­ter­parts, on­ly plans for one in­ter­im analy­sis that could al­low the com­pa­ny to stop the tri­al ear­ly and pe­ti­tion for an emer­gency use au­tho­riza­tion. That analy­sis is ex­pect­ed to oc­cur at 75 in­fec­tions. Mod­er­na ex­pects two analy­ses, at 53 and 106 events, while Pfiz­er pen­ciled in four — at 32, 62, 92 and 120 cas­es.

The British phar­ma al­so in­di­cat­ed that it is aim­ing for a 50% ef­fi­ca­cy rate for its can­di­date, the thresh­old that the FDA has set for in its coro­n­avirus vac­cine guide­lines, where­as Mod­er­na and Pfiz­er are both aim­ing for 60% ef­fec­tive­ness.

All three com­pa­nies al­so have dif­fer­ent cri­te­ria for symp­toms in the pri­ma­ry end­points of their tri­als, with each in­clud­ing those as­so­ci­at­ed with mild in­fec­tions. Er­ic Topol, one of the in­dus­try’s strongest ad­vo­cates for vac­cine trans­paren­cy, sum­ma­rized those dif­fer­ences in a tweet.

Vac­cine mak­ers have been un­der in­tense po­lit­i­cal pres­sure through­out the Covid-19 pan­dem­ic, but that has on­ly ramped up as No­vem­ber’s pres­i­den­tial elec­tion draws near­er. Pres­i­dent Don­ald Trump has re­peat­ed­ly of­fered promis­es that a vac­cine could be ready be­fore the elec­tion, and HHS sec­re­tary Alex Azar ef­fec­tive­ly set the FDA staff on no­tice say­ing that his sig­na­ture is re­quired on all rule mak­ing.

Thus far, Pfiz­er CEO Al­bert Bourla has been the on­ly ex­ec­u­tive to say his com­pa­ny could know whether or not its vac­cine works in Oc­to­ber. Mod­er­na pres­i­dent Stephen Hoge, ap­pear­ing on CBS Evening News last week, said the drug­mak­er could know if its own vac­cine works by No­vem­ber.

De­spite a green light to re­sume in the UK, As­traZeneca’s Phase III tri­al re­mains on hold in the US af­ter a vol­un­teer in the UK de­vel­oped a con­di­tion thought to be trans­verse myelitis, a rare spinal in­flam­ma­tion dis­or­der, af­ter tak­ing their sec­ond dose of the vac­cine. The com­pa­ny has not con­firmed the di­ag­no­sis, and a doc­u­ment post­ed by Ox­ford Uni­ver­si­ty last week sug­gest­ed that the vac­cine was not linked to the con­di­tion.

That in­stance was the sec­ond time As­traZeneca’s tri­al was placed on hold fol­low­ing a case of un­di­ag­nosed mul­ti­ple scle­ro­sis oc­cur­ring in a sep­a­rate tri­al par­tic­i­pant.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Steve Harr (L) and Hans Bishop

One of the most am­bi­tious start­up teams in biotech just out­lined plans for a $400M IPO and a val­u­a­tion of about $4B

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Lil­ly at­tempts to re­vive an old idea for tack­ling pain, li­cens­ing PhI pro­gram from Japan’s Asahi Ka­sei Phar­ma

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

Ther­mo Fish­er plat­form seeks to ex­pe­dite donor cell cul­ti­va­tion for al­lo­gene­ic cell ther­a­pies

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.

Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Covid-19 roundup: Con­tro­ver­sy around colchicine per­co­lates af­ter study fail­ure; As­traZeneca's meet­ing with EU was 'con­struc­tive,' but did­n't solve much

A group of researchers at the Montreal Heart Institute has spelled out what they had called positive results suggesting that colchicine, an inexpensive oral anti-inflammatory drug commonly used to treat gout, could prevent Covid-19 complications in newly diagnosed patients.

The study failed its primary endpoint. But the latest scientific debate around treatments for the coronavirus is just beginning to brew.

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