Catal­ent lands 2 new part­ner­ships, in­clud­ing for glioblas­toma drug; US drops $153M in­to pan­dem­ic pre­pared­ness

It’s been a qui­et few weeks for one of the busiest CD­MOs out there, but Catal­ent broke its lull with the an­nounce­ment of two part­ner­ships this week.

Cur­tana Phar­ma­ceu­ti­cals, an Austin, TX-based pre­clin­i­cal com­pa­ny, an­nounced a part­ner­ship with the man­u­fac­tur­er Thurs­day to make CT-179, its drug ther­a­py for glioblas­toma, medul­loblas­toma and oth­er brain can­cers.

CT-179 is a se­lec­tive small mol­e­cule in­hibitor of LIG2, a tran­scrip­tion fac­tor es­sen­tial to ear­ly brain de­vel­op­ment but of­ten not ex­pressed in adult brain cells. The de­vel­op­ment will take place at Catal­ent’s San Diego fa­cil­i­ty.

Catal­ent is al­so div­ing fur­ther in­to the world of cannabid­i­ols as it has un­der­tak­en a fea­si­bil­i­ty study for the de­vel­op­ment of a CBD anes­thet­ic pre­med­ica­tion.

The can­di­date would use Zy­dis, Catal­ent’s oral­ly dis­in­te­grat­ing tablet tech­nol­o­gy that dis­pers­es al­most in­stant­ly in a pa­tient’s mouth with­out wa­ter. JOS Phar­ma­ceu­ti­cals signed on to pro­vide its CBD ex­tract­ed from cer­ti­fied hemp to help de­vel­op se•d8, a wafer that would pro­vide awake se­da­tion for anes­the­sia ad­min­is­tered dur­ing cataract surgery and MRIs. The freeze-dried tablet will be stud­ied at Catal­ent’s 250,000-square-foot fa­cil­i­ty Swin­don, UK fa­cil­i­ty, and fo­cus on es­tab­lish­ing proof of con­cept and a pro­to­type.

Catal­ent’s Zy­dis tech­nol­o­gy will al­low for quick, easy ad­min­is­tra­tion, Catal­ent’s Pres­i­dent of Oral and Spe­cial De­liv­ery Jonathan Arnold said in the re­lease.

US De­part­ment of Com­merce awards $153M to pro­mote man­u­fac­tur­ing in­no­va­tion

US Sec­re­tary of Com­merce Gi­na Rai­mon­do has award­ed the Na­tion­al In­sti­tute for In­no­va­tion in Man­u­fac­tur­ing Bio­phar­ma­ceu­ti­cals two awards to­tal­ing $153 mil­lion to help aid fu­ture pan­dem­ic pre­pared­ness, she an­nounced Wednes­day.

NI­IM­BL is de­signed to ac­cel­er­ate vac­cine, mon­o­clon­al an­ti­body and gene ther­a­py pro­duc­tion. The first award will pro­vide $70 mil­lion over five years and al­low NI­IM­BL to de­vel­op a flex­i­ble, scal­able and cost-ef­fec­tive process that’s self-suf­fi­cient. The sec­ond will give $83 mil­lion over three years from the Amer­i­can Res­cue Plan to sup­port R&D to pre­vent and pre­pare for fu­ture out­breaks.

“I am so pleased that NI­IM­BL will con­tin­ue to bring to­geth­er or­ga­ni­za­tions of all types to help strength­en our na­tion through bet­ter pan­dem­ic pre­pared­ness and a more ag­ile man­u­fac­tur­ing in­dus­try,” Rai­mon­do said in a press re­lease.

Gen­tiBio to ben­e­fit from Forge’s AAV and man­u­fac­tur­ing

Gen­tiBio has part­nered with Forge Bi­o­log­ics to use its ade­no-as­so­ci­at­ed vi­ral vec­tor process and GMP man­u­fac­tur­ing ser­vice for its can­di­dates to treat au­toim­mune, al­loim­mune, au­toin­flam­ma­to­ry and al­ler­gic dis­eases.

The pro­gram will use both Forge’s Blaze Vec­tor plat­form and HEK 293 Sus­pen­sion Ig­ni­tion Cells. Man­u­fac­tur­ing will hap­pen at Forge’s 175,000-square-foot fa­cil­i­ty in Colum­bus, OH, dubbed The Hearth.

“We are thrilled to part­ner with Forge Bi­o­log­ics and their ex­pe­ri­enced team to fur­ther de­vel­op our lead en­gi­neered Treg pro­gram and take a crit­i­cal step in ad­vanc­ing our ther­a­pies to pa­tients in need,” Andy Walk­er, Gen­tiBio’s Chief Tech­nol­o­gy Of­fi­cer, said in a state­ment. “Forge of­fers a broad ar­ray of ser­vices rang­ing from process de­vel­op­ment to GMP man­u­fac­tur­ing, mak­ing them a strong part­ner for Gen­tiBio’s cell ther­a­pies with ca­pac­i­ty to sup­port Gen­tiBio as we ad­vance pro­grams through clin­i­cal de­vel­op­ment.”

Eli Lil­ly ac­quires NC land for po­ten­tial ex­pan­sion

It seems that every­one else is build­ing in North Car­oli­na’s Re­search Tri­an­gle, so Eli Lil­ly seems to be prepar­ing for that fu­ture as well.

The com­pa­ny an­nounced it has ac­quired an­oth­er 102 acres for $33.16 mil­lion across three pieces of land next to its cur­rent man­u­fac­tur­ing site in the park.

“We have pur­chased ad­di­tion­al land im­me­di­ate­ly ad­ja­cent to our site un­der con­struc­tion,” Eli Lil­ly said in a state­ment to the Tri­an­gle Busi­ness Jour­nal. “This land pur­chase fur­ther em­pha­sizes our com­mit­ment to RTP and al­lows for fu­ture ex­pan­sion op­por­tu­ni­ty.”

Lil­ly has plans to man­u­fac­ture di­a­betes drugs in the Raleigh-Durham area, it said in 2020, but did not dis­close where.

US ex­er­cis­es op­tion for small­pox vac­cine

De­spite the chaos caused by the last US col­lab­o­ra­tion with Emer­gent BioSo­lu­tions, the fed­er­al gov­ern­ment has ex­er­cised an op­tion to have the New Jer­sey-based CD­MO sup­ply dos­es of small­pox vac­cine to the na­tion­al stock­pile.

The op­tion was ex­er­cised as part of the drug­mak­er’s 10-year con­tract, worth about $182 mil­lion, The Wall Street Jour­nal re­port­ed.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.