Mene Pangalos (via AstraZeneca)

Un­der fire, As­traZeneca hus­tles out a pri­ma­ry cut of the num­bers for its Covid-19 vac­cine sup­port­ing pos­i­tive ef­fi­ca­cy

Af­ter spend­ing the last 48 hours in a pres­sure cook­er of wide­spread crit­i­cism, As­traZeneca has up­dat­ed its da­ta on its con­tro­ver­sial Covid-19 vac­cine.

The phar­ma gi­ant an­nounced Wednes­day evening that their vac­cine was 76% ef­fec­tive in the pri­ma­ry analy­sis, a small slip on over­all ef­fi­ca­cy from its first cut of the da­ta. There was 100% ef­fi­ca­cy in pre­vent­ing se­vere dis­ease and hos­pi­tal­iza­tion. The slight re­vi­sion still bears up well in com­par­i­son with the 72% ef­fi­ca­cy rate cit­ed by J&J for its vac­cine, leav­ing As­traZeneca in a sol­id po­si­tion to win an emer­gency au­tho­riza­tion from the FDA.

The da­ta came from 190 over­all cas­es of Covid-19, in­clud­ing 49 new cas­es since their pre­vi­ous da­ta cut. There were 8 cas­es of se­vere dis­eases, all of them in the place­bo group.

As­traZeneca R&D leader Mene Pan­ga­los says the com­pa­ny is push­ing straight ahead with its re­quest for emer­gency au­tho­riza­tion in the US.

The pri­ma­ry analy­sis is con­sis­tent with our pre­vi­ous­ly re­leased in­ter­im analy­sis, and con­firms that our COVID-19 vac­cine is high­ly ef­fec­tive in adults, in­clud­ing those aged 65 years and over. We look for­ward to fil­ing our reg­u­la­to­ry sub­mis­sion for Emer­gency Use Au­tho­riza­tion in the US and prepar­ing for the roll­out of mil­lions of dos­es across Amer­i­ca.

As­traZeneca had earned ku­dos on Mon­day with a round of in­ter­im da­ta that spot­light­ed a 79% rate in pre­vent­ing symp­to­matic Covid-19 with a 100% elim­i­na­tion of se­vere dis­ease. For the multi­na­tion­al op­er­a­tion, that score marked a dra­mat­ic turn­around from the roast­ing it was get­ting in Eu­rope and around the world as ex­perts and health of­fi­cials ques­tioned its ef­fec­tive­ness in com­bat­ing vari­ants or in peo­ple over the age of 65.

But that mo­men­tary turn of events evap­o­rat­ed late Mon­day, af­ter the DSMB charged with over­see­ing the tri­al alert­ed of­fi­cials at the NIH that the com­pa­ny had ig­nored its rec­om­men­da­tion to tell the pub­lic that the da­ta they were see­ing in Feb­ru­ary and March in­di­cat­ed a rate of 69% to 74%.

It amount­ed to sim­ple cher­ry pick­ing of the da­ta, they not­ed. In their let­ter, which The Wash­ing­ton Post ob­tained, the ob­servers not­ed:

The point that is clear to the board is that the [vac­cine ef­fi­ca­cy num­ber] . . . they chose to re­lease was the most fa­vor­able for the study as op­posed to the most re­cent and most com­plete. De­ci­sions like this are what erode pub­lic trust in the sci­en­tif­ic process.

That sort of em­bell­ish­ment was wide­ly con­demned, and Scripps’ Er­ic Topol added to the din of crit­i­cism, re­peat­ed­ly as­sert­ing on Twit­ter that As­traZeneca could in­stant­ly clear the air.

NI­AID chief An­tho­ny Fau­ci, mean­while, con­sis­tent­ly as­sert­ed that while the da­ta may have been wrong, the fi­nal num­bers would bear out its over­all val­ue.

The new da­ta help con­firm that as­ser­tion, al­though the num­bers are still not en­tire­ly set­tled: As­traZeneca said that there were 14 ad­di­tion­al pos­si­ble Covid-19 cas­es that had yet to be ful­ly ad­ju­di­cat­ed.

At this stage of the game, af­ter so much crit­i­cism in a storm of con­tro­ver­sy, the vac­cine is still like­ly to run in­to stiff re­sis­tance — par­tic­u­lar­ly in the more af­flu­ent na­tions that have a choice. Poor coun­tries, though, now may have lit­tle choice in the mat­ter.

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

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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Pa­tient death spurs tri­al halt for Ma­gen­ta Ther­a­peu­tics

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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Vu Truong, Aridis Pharmaceuticals CEO (Aridis/Nasdaq)

Aridis' mon­o­clon­al an­ti­body fails PhI­II, but plans for sec­ond tri­al any­way

Aridis Pharmaceuticals’ monoclonal antibody missed the bar in a Phase III test in ventilator-associated pneumonia caused by the gram-positive bacteria S. aureus, the company announced Wednesday. 

But Aridis is planning for a second Phase III study anyway once it discusses the findings with the FDA and the European Medicines Agency. Execs blamed recruitment challenges stemming from Covid-19 and Russia’s invasion of Ukraine for the miss, cutting their enrollment target in half.

Al Gianchetti, XyloCor CEO

Xy­lo­Cor wraps up PhII for heart dis­ease gene ther­a­py, plans for piv­otal tri­al

XyloCor Therapeutics says patients with heart disease who got its gene therapy could exercise for longer and had fewer chest pain attacks. The biotech announced it completed a Phase I/II trial of the gene therapy Thursday morning, and plans to move forward with a pivotal trial.

In the Phase II portion of the trial, 28 patients with angina (or chest pain) caused by coronary artery disease and who had no other treatment options were enrolled and were given the highest tested dose from the first part of the trial. Patients were followed for six months.