Vered Caplan, Orgenesis CEO

Johns Hop­kins and lo­cal biotech team up for new man­u­fac­tur­ing site; New oral drug plat­form to help ac­cel­er­ate R&D time­line

Johns Hop­kins Uni­ver­si­ty and a Mary­land-based biotech will join forces to de­vel­op a cell and gene ther­a­py pro­cess­ing fa­cil­i­ty at the uni­ver­si­ty, set to open in 2023.

Or­ge­n­e­sis will join forces on the POCare Cen­ter, al­so known as the Mary­land Cen­ter for Cell Ther­a­py Man­u­fac­tur­ing, in part thanks to a $5 mil­lion grant from the state. The fa­cil­i­ty will be 7,000 square feet, and help clin­i­cians and re­searchers at Johns Hop­kins with a more stream­lined path from the lab to pa­tient tri­als. This al­lows for more in-house man­u­fac­tur­ing, and less out­sourc­ing to third par­ties.

Right now, Or­ge­n­e­sis is us­ing lab space at Fast­For­ward, Johns Hop­kins Tech­nol­o­gy Ven­tures’ In­no­va­tion Hub. The com­pa­ny will send 30 of its em­ploy­ees at the site next year up­on com­ple­tion.

In a state­ment, CEO Vered Ca­plan said:

Or­ge­n­e­sis con­tin­ues to de­vel­op and ex­tend key part­ner­ships with­in its in­ter­na­tion­al POCare Net­work. These in­ter­na­tion­al part­ner­ships are now ex­pe­ri­enc­ing sig­nif­i­cant in­vest­ment and con­struc­tion across the globe to build on the achieve­ments with­in the Net­work, as il­lus­trat­ed by our ex­pand­ed col­lab­o­ra­tion with Johns Hop­kins. We are hon­ored to work with Johns Hop­kins, Amer­i­ca’s first re­search uni­ver­si­ty and home to nine world-class aca­d­e­m­ic di­vi­sions work­ing to­geth­er in one uni­ver­si­ty. The POC Cen­ter at Johns Hop­kins will help pro­pel the de­vel­op­ment of ther­a­pies tar­get­ing a range of con­di­tions that di­rect­ly af­fect the lives of mil­lions of pa­tients.

Con­struc­tion will start next quar­ter and should be com­plet­ed by Q2 2023.

New oral drug plat­form to help ac­cel­er­ate R&D time­line

Catal­ent is launch­ing its new Xpress Phar­ma­ceu­ti­cals ser­vice to ac­cel­er­ate the de­vel­op­ment of oral drugs through Phase I clin­i­cal stud­ies. The ap­proach us­es on-de­mand clin­i­cal man­u­fac­tur­ing, clin­i­cal test­ing and reg­u­la­to­ry sup­port to re­duce the cost and time tak­en to com­plete in-hu­man tri­als.

The ser­vice al­lows Catal­ent to work along­side in­no­va­tor and clin­i­cal re­search or­ga­ni­za­tions, and pro­vide ma­te­r­i­al with the nec­es­sary da­ta to pre­pare for dos­ing pa­tients at a clin­i­cal site. The ser­vice will be car­ried out at Catal­ent’s Not­ting­ham, UK, and Bein­heim, France, sites.

“Achiev­ing ear­ly clin­i­cal suc­cess mile­stones as fast as pos­si­ble is cru­cial in mod­ern drug de­vel­op­ment, es­pe­cial­ly for emerg­ing in­no­va­tors, and this new ser­vice com­bines Catal­ent’s core ex­per­tise in drug for­mu­la­tion with man­u­fac­tur­ing, an­a­lyt­ics, and reg­u­la­to­ry ex­per­tise, to de­sign bet­ter drugs for use in adap­tive tri­als,” said Jonathan Arnold, the pres­i­dent of oral and spe­cial­ty de­liv­ery.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

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.”

Man­u­fac­tur­ing roundup: Phar­maron se­cures ac­qui­si­tion of a Rhode Is­land fa­cil­i­ty; GSK to open hub in South Amer­i­ca

A Chinese pharma company is growing its presence in the US with a newly acquired API manufacturing site.

Pharmaron has entered into a definitive agreement to acquire a Coventry, Rhode Island-based API manufacturing site from drug manufacturer Noramco, which was previously owned by Johnson & Johnson and now owned by the private equity firm SK Capital.

According to Pharmaron, the site has an established history of API manufacturing from pilot kilogram to commercial metric ton scales. However, according to The People’s Radio, an NPR station covering Rhode Island and parts of Massachusetts, the facility was formerly owned by a subsidiary of Purdue Pharmaceuticals called Rhodes Technologies and was known for making opioid products. According to that report, because of Purdue’s 2019 bankruptcy filing, the Coventry factory was sold to Noramco, another opioid ingredient manufacturer.

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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