Covid-19 roundup: Top an­a­lyst pokes hole in As­traZeneca/Ox­ford da­ta while sci­en­tists tam­per hope for fast roll­out

As­traZeneca and Ox­ford may have out­shone Pfiz­er and BioN­Tech — at least in terms of me­dia at­ten­tion — with Phase I re­sults on its Covid-19 vac­cine ini­tial­ly. But a clos­er look sug­gests the ade­n­ovirus-based can­di­date doesn’t ex­act­ly match the bar set by mR­NA vac­cines on of­fer, in­clud­ing one from Mod­er­na.

The bot­tom line, writes Bern­stein’s Ron­ny Gal, is that while the As­traZeneca da­ta are clear­ly pos­i­tive, “in the com­pet­i­tive con­text they fail to im­press.”

To be sure, all we’ve seen so far is pre­lim­i­nary bio­mark­er da­ta on an­ti­bod­ies and T cells that may in­di­cate but by no means guar­an­tee ef­fi­ca­cy. Yet Gal takes is­sue, al­beit with caveat, with the im­muno­genic­i­ty lev­els on dis­play in As­traZeneca and Ox­ford’s dataset, pub­lished in The Lancet:

(i) The titers from im­mu­nized pa­tients were low­er than con­va­les­cent pa­tients, where as BioN­tech and Mod­er­na vac­cines both elicit­ed Ig­Gs sub­stan­tial­ly high­er than con­va­les­cent con­trols (but each com­pa­ny used dif­fer­ent con­va­les­cent group, so di­rect com­par­i­son is not pos­si­ble).

(ii) Even the prime boost group was at most even with con­va­les­cent pa­tients (low­er on some of the as­says).

(iii) Mark­ers of cel­lu­lar im­mu­ni­ty are present, but not bro­ken down be­tween CD4 and CD8, peakear­ly and de­cline, and the mag­ni­tude is dif­fi­cult to in­ter­pret.

It doesn’t help that the da­ta are writ­ten up to high­light the small, 10-per­son group that re­ceived the prime/boost reg­i­men, while ref­er­ence val­ues of con­va­les­cent sera and de­tails on cel­lu­lar im­mu­ni­ty were miss­ing.

“While these are com­mon is­sues with sci­en­tif­ic da­ta pre­sen­ta­tion, in the con­text of the C19 glob­al ef­fort, the lev­el of or­ga­ni­za­tion here is unim­pres­sive,” he wrote.

Pfiz­er and BioN­Tech, by con­trast, of­fered a much more pos­i­tive im­pres­sion in their not-yet peer-re­viewed preprint. An­ti­body re­sponse was stronger in the vac­cine group com­pared to pa­tients who re­cov­ered from Covid-19, across a va­ri­ety of vi­ral mu­tants. CD4 and CD8 were pre­sent­ed sep­a­rate­ly with a break­down for cy­tokines. There was even cor­re­la­tion be­tween cel­lu­lar and hu­moral im­mu­ni­ty.

That said, any da­ta sup­port­ing po­ten­tial ef­fi­ca­cy is good news, even if the strong re­sults be­long to the mR­NA play­ers, Gal wrote. They al­so seem to point to prime-boost as a fa­vor­able ap­proach — an at­ti­tude that As­traZeneca ex­ecs echoed.

“Ef­fi­ca­cy da­ta will be out by Sep­tem­ber, these re­sults sug­gest some ef­fi­ca­cy is like­ly – let’s see how much (and for how long),” he con­clud­ed.

Roll­out of Ox­ford vac­cine by end of year pos­si­ble but ‘there’s ab­solute­ly no cer­tain­ty’ — lead sci­en­tist

As ex­pec­ta­tions mount fol­low­ing the pub­li­ca­tion of da­ta, Ox­ford sci­en­tists and UK of­fi­cials are both cau­tious about the pre­cise time­line for a vac­cine to be­come avail­able.

The hope, ex­pressed by their part­ners at As­traZeneca as re­cent­ly as Mon­day, had been to have it for emer­gency use be­fore 2020 ends. It’s a sen­ti­ment shared by the US, where the White House has set up Op­er­a­tion Warp Speed to hit the goal.

“The end of the year tar­get for get­ting vac­cine roll-out, it’s a pos­si­bil­i­ty but there’s ab­solute­ly no cer­tain­ty about that be­cause we need three things to hap­pen,” Sarah Gilbert, who leads the team that de­vel­oped the ade­n­ovirus-based vac­cine, told BBC Ra­dio.

The on­go­ing late-stage tri­als would need to show that it works; the man­u­fac­tur­ing part­ners would have to de­liv­er on the mil­lion dos­es slat­ed for Sep­tem­ber; and a sig­noff from reg­u­la­tors would be the fi­nal gat­ing fac­tor.

Even chief med­ical of­fi­cer Chris Whit­ty and his deputy Jonathan Van-Tam don’t seem to agree on just how op­ti­mistic the coun­try should be.

“The chance of us get­ting a vac­cine be­fore Christ­mas that ac­tu­al­ly is high­ly ef­fec­tive are, in my view, very low,” Whit­ty told law­mak­ers, per Reuters, while Van-Tam said he was “cau­tious­ly op­ti­mistic” it would hap­pen.

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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.