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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

As the Office of Tissue and Advanced Therapies (OTAT) transforms into the Office of Therapeutic Products (OTP), with new user fee funds and “super office” status, the department focused on cell and gene therapies also opened its doors to a town hall Thursday offering clarification on guidance and regulations for manufacturers.

Some of the major concerns from manufacturers were the CMC considerations between first-in-human studies and late-phase studies supporting a marketing approval.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.