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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty


I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Break­ing: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales.

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With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

Between 2017 and 2019, Medicare spent more than $220 million on cancer drugs for which the indications were either voluntarily pulled by their applicants or FDA’s oncology adcomm had recommended their withdrawal.

That kind of massive spending on cancer drugs lacking overall survival benefit is wasteful and risks harming people’s health, a research letter published in JAMA Internal Medicine on Monday said. The researchers from Harvard and the London School of Economics called on the FDA to move faster in both requiring timely postmarketing trials and accelerating the speed in pulling these dangling approvals when the confirmatory studies fail.

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Raymond Stevens, ShouTi Pharma CEO

A new Schrödinger-backed start­up emerges from the sci­en­tist who mapped the first hu­man GPCR

One of the most popular targets in drug development, representing about a third of existing drugs, are G-protein coupled receptors — the tiny but integral membrane proteins responsible for recognizing things like light, taste, smell, hormones and pain.

But due to challenges in mapping their structure, the protein family remains largely unexplored.

A slate of companies has emerged over the last few years to change that. If one can figure out the structure of these elusive membrane receptors, it might be possible to create small molecule drugs that overcome the limitations of, say, biologic and peptide therapies. That promise is what gets serial entrepreneur Raymond Stevens out of bed in the morning.

Carl June (Brian Ach/Getty Images for TIME 100 Health Summit)

Carl June lends 'wings' to Chi­nese CAR-T start­up led by for­mer post­doc, pur­su­ing off-the-shelf ap­proach with CRISPR fla­vor

Carl June still has plenty of energy to bring forth new iterations of CAR-T technology — wherever they’re coming from.

Adding another role to his already lengthy list of titles, June is joining the scientific advisory board at Nanjing Bioheng Biotech, where he will serve as chairman.

The appointment, if slightly out of the ordinary, is both a testament to the fruitfulness of June’s lab at the University of Pennsylvania and China’s increasing appeal to biotech entrepreneurs educated overseas.