Covid-19 roundup: As­traZeneca ships first CO­V­AX dos­es as Cana­da rec­om­mends against 65+ use; In­ovio, still stuck in PhI­II, to re­spond to FDA in May

As­traZeneca’s Covid-19 vac­cine has had a bumpy ride, but the promi­nent drug­mak­er is ready to start sup­ply­ing their shots to CO­V­AX.

The first dos­es of the As­traZeneca/Ox­ford vac­cine were shipped to Ghana and Cote D’Ivoire, As­traZeneca an­nounced Tues­day, with more set to be­gin ar­riv­ing this week in the Philip­pines, In­done­sia, Fi­ji, Mon­go­lia and Moldo­va. For many of these coun­tries, these dos­es rep­re­sent their first Covid-10 vac­cines, As­traZeneca said.

Pub­lic doc­u­ments from mid-Jan­u­ary re­leased by Gavi, one of the or­ga­ni­za­tions be­hind the CO­V­AX ef­fort, showed As­traZeneca and the Serum In­sti­tute have teamed up to pro­vide 550 mil­lion shots. As­traZeneca it­self is al­so giv­ing an­oth­er 170 mil­lion dos­es on its own.

Tues­day’s an­nounce­ments comes a few days af­ter Cana­da au­tho­rized the vac­cine for use in adults old­er than 18. But not all has been peachy up north, with the coun­try’s im­mu­niza­tion ad­vi­so­ry pan­el Mon­day rec­om­mend­ing against us­ing the shot to in­oc­u­late in­di­vid­u­als old­er than 65, Reuters re­port­ed, cit­ing a lack of ef­fi­ca­cy in­for­ma­tion in that age group.

In its de­ci­sion to green­light the shot Fri­day, the Cana­di­an drug reg­u­la­tor Health Cana­da said there are too few da­ta to es­ti­mate how ef­fec­tive the shot could be among the 65-and-up age group. But it al­so not­ed “emerg­ing re­al world ev­i­dence” in places us­ing the shot, such as Scot­land, sug­gests a po­ten­tial ben­e­fit and no safe­ty con­cerns.

As­traZeneca has en­coun­tered sig­nif­i­cant head­winds in its ef­forts to de­vel­op a Covid-19 vac­cine. They were the first com­pa­ny to re­port a se­vere ad­verse event in one of their Phase III tri­als back in Sep­tem­ber, when a healthy British vol­un­teer in the vac­cine arm de­vel­oped what was thought to be a rare neu­ro­log­i­cal dis­or­der.

The set­back caused a glob­al tri­al hold, and while it re­sumed quick­ly over­seas, the tri­al took longer to get go­ing again in the US. Britain and the EU have since au­tho­rized the shot for use, but it’s still await­ing the green light state­side.

But those au­tho­riza­tions haven’t lift­ed the drug­mak­er’s strug­gles, ei­ther. Ten­sions be­tween As­traZeneca and EU have spilled over in­to pub­lic view, with both par­ties trad­ing blows af­ter the com­pa­ny said it wouldn’t be able to de­liv­er the amount of vac­cines promised in its con­tracts.

Some EU mem­bers, such as Italy, have ques­tioned whether they’re al­lowed to sue As­traZeneca for reneg­ing on its deal. But when the EU ac­ci­den­tal­ly pub­lished the com­pa­ny’s con­tract with redac­tions that were eas­i­ly re­moved by in­ter­net sleuths and Ger­man jour­nal­ists, the text ap­peared to back up CEO Pas­cal So­ri­ot’s claim that the shots promised fell un­der a “best ef­fort” clause, forc­ing the EU in­to apol­o­giz­ing.

On top of that, peo­ple in coun­tries where the As­traZeneca shot has been au­tho­rized are re­port­ed­ly shun­ning the vac­cine in fa­vor of mR­NA-based shots with high­er topline ef­fi­ca­cy lev­els.

In­ovio won’t re­spond to FDA un­til May as PhI­II still un­der hold

In­ovio’s vac­cine is still on par­tial clin­i­cal hold by the FDA, and it doesn’t ap­pear that the hold is go­ing away any­time soon.

In a 10-K fil­ing sub­mit­ted to the SEC on Mon­day, In­ovio said they are plan­ning to re­spond to reg­u­la­tors in May, rough­ly eight months af­ter the agency pressed the pause but­ton on their INO-4800 pro­gram. That com­mu­ni­ca­tion would be fol­lowed by an­oth­er 30-day pe­ri­od to see what the FDA has to say about any po­ten­tial ques­tions.

And they read­i­ly ad­mit that their ef­forts may end up be­ing fruit­less.

“We do not know whether our planned Phase 3 clin­i­cal tri­al will be­gin on time or be com­plet­ed on sched­ule, if at all,” In­ovio wrote in the 10-K.

The FDA placed the hold on the Phase III por­tion of a Phase II/III tri­al in Sep­tem­ber due to ques­tions about the de­vice that will be used to de­liv­er In­ovio’s shot di­rect­ly to the skin. Ac­cord­ing to an In­ovio state­ment from De­cem­ber, the com­pa­ny plans on an­swer­ing those re­main­ing ques­tions in the Phase II part of the study.

In Jan­u­ary, In­ovio part­nered with Ad­vac­cine Bio­phar­ma­ceu­ti­cals Suzhou to de­vel­op and com­mer­cial­ize the vac­cine can­di­date in Chi­na, Hong Kong, Tai­wan and Macau. In ad­di­tion to $3 mil­lion up­front, Ad­vac­cine promised up to $108 mil­lion in mile­stone pay­ments.

But the vac­cine set­backs have not hurt In­ovio’s cash flow. In a fourth-quar­ter and full-year earn­ing re­port re­leased Mon­day, the com­pa­ny said it raised $454 mil­lion in 2020.

No­vavax asks FDA to con­sid­er glob­al da­ta

With three vac­cines now au­tho­rized for use in the US, No­vavax has re­port­ed­ly ap­proached the FDA to ac­cel­er­ate its path to be­come the fourth.

Stan­ley Er­ck

The biotech’s CEO Stan­ley Er­ck has asked reg­u­la­tors to con­sid­er tri­al da­ta from the UK and South Africa as part of its EUA, ac­cord­ing to a Ya­hoo! Fi­nance re­port Mon­day, say­ing that wait­ing for US re­sults would de­lay a de­ci­sion by a “cou­ple of months.” Er­ck made the com­ments in an earn­ings call Mon­day af­ter­noon, and said he hopes No­vavax will have shipped 110 mil­lion vac­cine dos­es by Ju­ly.

He sep­a­rate­ly told Ya­hoo! Fi­nance that the FDA has done this be­fore and hopes it can do so in this in­stance as well.

Er­ck com­pared the US au­tho­riza­tion process to that in the UK, where reg­u­la­tors ac­cept da­ta on a rolling ba­sis. British of­fi­cials are set to an­a­lyze their glob­al Phase III tri­al da­ta by the end of the month, which showed in Jan­u­ary the shot was 89.3% ef­fec­tive in the UK, but on­ly 49.4% ef­fec­tive in the tri­al’s South Africa arm.

If all goes well in Britain, the coun­try could au­tho­rize the vac­cine in May, Er­ck said.

No­vavax’s US tri­al on­ly re­cent­ly com­plet­ed its 30,000-pa­tient en­roll­ment af­ter mul­ti­ple de­lays, how­ev­er. In the mean­time, the com­pa­ny is look­ing to ramp up pro­duc­tion of its shots, and last month upped its com­mit­ment to CO­V­AX to pro­vide 1.1 bil­lion shots to the glob­al vac­cine eq­ui­ty ef­fort. Hav­ing part­nered al­ready with sev­er­al glob­al man­u­fac­tur­ers, No­vavax is aim­ing to reach full pro­duc­tion ca­pac­i­ty — 2 bil­lion shots per year — by mid-2021.

The Covid-19 pan­dem­ic has of­fered No­vavax the best fi­nan­cial news it’s had in years thanks to a $1.6 bil­lion Warp Speed con­tract, hav­ing teetered on in­sol­ven­cy pri­or to 2020. No­vavax $NVAX shares trad­ed be­low $4 apiece at the end of 2019, but since then have risen near­ly 6,700%.

Fau­ci push­es back on ‘first shots first’ push

Af­ter some de­bate that the US should un­der­take a “first shots first” strat­e­gy, in get­ting first vac­cine dos­es out to as many peo­ple as pos­si­ble, NI­AID chief An­tho­ny Fau­ci pumped the brakes Mon­day evening.

Fau­ci said the US gov­ern­ment will con­tin­ue its two-shot dos­ing plan for the Pfiz­er/BioN­Tech and Mod­er­na vac­cines, per the Wash­ing­ton Post. He not­ed that while the strat­e­gy has os­ten­si­bly worked in Britain, it wouldn’t make sense to do so in the US.

Not on­ly would get­ting out more first dos­es leave peo­ple less pro­tect­ed from the virus, Fau­ci said, it would en­able vari­ants to spread and con­tin­ue to feed vac­cine hes­i­tan­cy across the coun­try. He cit­ed re­search that showed one shot of the mR­NA-based vac­cines may not pro­vide enough pro­tec­tion from the coro­n­avirus vari­ant that first emerged in South Africa.

“We’re telling peo­ple [two shots] is what you should do … and then we say, ‘Oops, we changed our mind’?” Fau­ci told WaPo. “I think that would be a mes­sag­ing chal­lenge, to say the least.”

The “first shots first” push gained trac­tion over the week­end fol­low­ing the FDA’s au­tho­riza­tion of J&J’s sin­gle-shot vac­cine. Some pub­lic health ex­perts have been urg­ing the US to fol­low this strat­e­gy in or­der to of­fer at least some pro­tec­tion to a greater num­ber of peo­ple, and on Mon­day two De­mo­c­ra­t­ic sen­a­tors called on the Biden ad­min­is­tra­tion to be­gin such ef­forts.

J&J’s vac­cine au­tho­riza­tion has al­so dri­ven con­cerns over the rise of a po­ten­tial two-tiered dis­tri­b­u­tion sys­tem, ac­cord­ing to WaPo, where the eas­i­er-to-store J&J shot is giv­en to places typ­i­cal­ly hard­er to reach. While those de­ci­sions make lo­gis­ti­cal sense, it could end up leav­ing mar­gin­al­ized com­mu­ni­ties get­ting what they think is an in­fe­ri­or prod­uct due to low­er topline ef­fi­ca­cy re­sults, the re­port said.

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

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.