Covid-19 roundup: Till­man Gern­gross inks deal to bring an­ti­body can­di­date to In­dia; At FDA's re­quest, mR­NA vac­cine mak­ers will ex­pand tri­als for chil­dren ages 5-11

A week af­ter it was re­port­ed that In­dia’s Covid-19 death toll could be in the mil­lions, an­ti­body leg­end Till­man Gern­gross has inked a deal to de­vel­op Ada­gio’s lead can­di­date for the treat­ment and pre­ven­tion of the virus in south­ern Asia.

Ada­gio is join­ing hands with Bio­con Bi­o­log­ics to man­u­fac­ture and com­mer­cial­ize a treat­ment based on ADG20 in In­dia and “se­lect emerg­ing mar­kets,” the com­pa­nies an­nounced on Mon­day. Un­der the agree­ment, Ada­gio will pro­vide Bio­con with ma­te­ri­als and know-how to make the ther­a­py, in­clud­ing da­ta from on­go­ing Phase II/III tri­als and (if all goes well) ac­cess to its po­ten­tial EUA pack­age.

The fi­nan­cial terms of the deal weren’t dis­closed.

Till­man Gern­gross

ADG20 is cur­rent­ly in two Phase II/III tri­als: one for the treat­ment of non-hos­pi­tal­ized Covid pa­tients, and one for the pre­ven­tion of Covid-19. Back in May, Ada­gio of­fered a first peek at ear­ly Phase I da­ta, which sug­gest­ed a sin­gle dose of­fered broad­ly neu­tral­iz­ing ac­tiv­i­ty com­pa­ra­ble to peak titers re­port­ed from the mR­NA vac­cines.

“As a com­pa­ny, it is our be­lief that the phar­ma­ceu­ti­cals in­dus­try has a hu­man­i­tar­i­an re­spon­si­bil­i­ty to serve pa­tients who are in need,” Ki­ran Mazum­dar-Shaw, ex­ec­u­tive chair­per­son at Bio­con, said in a state­ment. “We had looked at dozens of po­ten­tial mol­e­cules, and up­on re­view­ing the ADG20 da­ta, we were con­vinced this was a dif­fer­en­ti­at­ed an­ti­body with the po­ten­tial to ad­dress not on­ly to­day’s virus and vari­ants, but fu­ture SARS-like virus­es as well.”

Ki­ran Mazum­dar-Shaw

In April, Ada­gio snagged $336 mil­lion as part of a Se­ries C round led by RA Cap­i­tal to ad­vance the an­ti­body through the STAMP tri­al for the treat­ment of high-risk, mild to mod­er­ate Covid pa­tients.

“Im­por­tant­ly, Bio­con’s ex­ten­sive man­u­fac­tur­ing ca­pa­bil­i­ties will en­able large scale pro­duc­tion, mak­ing this po­ten­tial­ly life-sav­ing drug broad­ly avail­able to mil­lions of peo­ple who oth­er­wise would not have ac­cess to this type of ther­a­py,” Gern­gross said. — Nicole De­Feud­is 

At FDA’s re­quest, mR­NA vac­cine mak­ers will ex­pand tri­als for chil­dren ages 5-11

In an ef­fort to track rare side ef­fects, Pfiz­er-BioN­Tech and Mod­er­na will ex­pand clin­i­cal tri­als for chil­dren to as young as 5 years old, the New York Times re­port­ed Mon­day.

The mea­sure is to de­tect side ef­fects such as heart in­flam­ma­tion prob­lems that ap­pear in vac­ci­nat­ed peo­ple un­der 30. There’s not yet a time­line for when pe­di­atric vac­cines will be­come avail­able, though at a meet­ing in Ohio last week, Pres­i­dent Joe Biden promised that emer­gency au­tho­riza­tion is com­ing soon.

Both com­pa­nies have been in­struct­ed by the FDA that the pe­di­atric stud­ies are not big enough nor broad enough to de­tect rare side ef­fects, in­clud­ing my­ocardi­tis and peri­cardi­tis, the in­flam­ma­tion of the heart mus­cle or the lin­ing around the heart.

The push comes as schools around the coun­try are set to open in the next two months.

An­oth­er 3,000 chil­dren be­tween the ages of 5 and 11 years old will join the tri­al at the FDA’s re­quest. Mod­er­na start­ed re­cruit­ing pa­tients in March, while the Times says that Pfiz­er is on a faster timetable than Mod­er­na and could be able to meet the FDA’s re­quest and still file for emer­gency use au­tho­riza­tion in chil­dren by the end of Sep­tem­ber. Pfiz­er has pre­vi­ous­ly said that it ex­pects to have re­sults for the youngest age group — 6 months to 2 years old — by Oc­to­ber or No­vem­ber. — Josh Sul­li­van

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

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.

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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.