Mathai Mammen, Janssen global head of R&D (Rob Tannenbaum, Endpoints News)

Covid-19 roundup: Study shows J&J's shot is much less ef­fec­tive against Delta vari­ant; No­var­tis open to man­u­fac­tur­ing oth­er coro­n­avirus vac­cines — re­port

As the Delta vari­ant rapid­ly spreads across the US — ac­count­ing for 83% of the coun­try’s cas­es, CDC di­rec­tor Rochelle Walen­sky said yes­ter­day — a new study shows the con­cern­ing strain ren­ders John­son & John­son’s sin­gle-dose Covid-19 shot much less ef­fec­tive.

The study, which has not been peer-re­viewed, showed that neu­tral­iz­ing titers in­duced by J&J’s vac­cine de­creased 5.4-fold against the “Delta plus” vari­ant, a mu­ta­tion that sci­en­tists say al­lows the virus to bet­ter at­tack the lungs. In com­par­i­son, titers in­duced by Pfiz­er/BioN­Tech’s can­di­date de­creased by 2.7-fold against the Delta plus vari­ant, and lev­els dropped 3.3-fold for Mod­er­na’s can­di­date.

“The mes­sage that we want­ed to give was not that peo­ple shouldn’t get the J&J vac­cine, but we hope that in the fu­ture, it will be boost­ed with ei­ther an­oth­er dose of J&J or a boost with Pfiz­er or Mod­er­na,” Nathaniel Lan­dau, a vi­rol­o­gist who led the study, told the New York Times. 

That con­clu­sion dif­fers from a state­ment J&J made ear­li­er this month, in which it claimed the vac­cine demon­strat­ed “strong, per­sis­tent ac­tiv­i­ty” against the Delta vari­ant. J&J said the shot showed a durable im­mune re­sponse through at least eight months post-vac­ci­na­tion.

“Cur­rent da­ta for the eight months stud­ied so far show that the sin­gle-shot John­son & John­son COVID-19 vac­cine gen­er­ates a strong neu­tral­iz­ing an­ti­body re­sponse that does not wane; rather, we ob­serve an im­prove­ment over time,” said Math­ai Mam­men, glob­al head of Janssen’s R&D.

Dis­tri­b­u­tion of J&J’s vac­cine was paused briefly in the US ear­li­er this year over con­cerns of rare but some­times fa­tal blood clots. The FDA and CDC lift­ed the pause back in April af­ter de­cid­ing the shot’s known and po­ten­tial ben­e­fits still out­weigh the risks, and up­dat­ing fact sheets to in­clude a risk of blood clots and low lev­els of platelets.

Ear­li­er this month, the FDA is­sued a sec­ond warn­ing for the vac­cine, adding that there are da­ta “con­nect­ing the shot to an in­creased risk” of Guil­lain-Bar­ré syn­drome, a rare con­di­tion where the body’s im­mune sys­tem at­tacks its nerves.

No­var­tis open to man­u­fac­tur­ing oth­er Covid-19 vac­cines — re­port

While No­var­tis no longer has a vac­cines busi­ness, the Swiss phar­ma has of­fered its man­u­fac­tur­ing ser­vices to help pro­duce two mR­NA vac­cines for Covid-19 — and ac­cord­ing to a Reuters re­port, it’s open to help­ing oth­er com­pa­nies as well.

Back in March, No­var­tis an­nounced it would help man­u­fac­ture bulk drug sub­stance for Cure­Vac’s mR­NA-based Covid-19 shot, dubbed CVn­CoV, at its Kundl, Aus­tria site. The com­pa­ny al­so jumped in to help man­u­fac­ture Pfiz­er/BioN­Tech’s ul­tra-ef­fec­tive vac­cine back in Jan­u­ary.

On Wednes­day, fi­nance chief Har­ry Kirsch told re­porters No­var­tis is on track to de­liv­er 50 mil­lion dos­es of Cure­Vac’s vac­cine this year.

While the mR­NA vac­cines de­vel­oped by Pfiz­er/BioN­Tech and Mod­er­na both achieved ef­fi­ca­cy rates high­er than 90%, Cure­Vac said last month that its jab was on­ly 48% ef­fec­tive in a piv­otal tri­al.

While reg­u­la­tors have set the ef­fi­ca­cy bar at 50% for new Covid-19 vac­cines, CEO Franz-Wern­er Haas said he still in­tends to seek li­cen­sure for the vac­cine, par­tic­u­lar­ly in the EU and for cer­tain age groups that per­formed bet­ter in the tri­al.

Cure­Vac said the vac­cine was 53% ef­fec­tive at pre­vent­ing symp­to­matic dis­ease in tri­al par­tic­i­pants 60 years old and younger. And if you ex­clude mild cas­es as well as those old­er than 60, the vac­cine was 77% ef­fec­tive at pre­vent­ing mod­er­ate to se­vere symp­toms, Cure­Vac said.

This ar­ti­cle has been cor­rect­ed to re­flect that Cure­Vac’s vac­cine was 53% ef­fec­tive in tri­al par­tic­i­pants 60 years old and younger. A pre­vi­ous ver­sion in­cor­rect­ly stat­ed that the vac­cine was 53% ef­fec­tive in on­ly those younger than 60. 

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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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.

Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.