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.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.

Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.