Man­u­fac­tur­ing roundup: Cel­l­Vax part­ners up with Ther­a­gent for PhII tri­al; Ox­ford Bio­med­ica sells fa­cil­i­ty for $70M+

The cell ther­a­py CD­MO Ther­a­gent has roped in a man­u­fac­tur­ing con­tract for a Phase II tri­al.

The com­pa­ny is work­ing on Cel­l­Vax Ther­a­peu­tics’ im­munother­a­py can­di­date FK-PC101, a cell-based au­tol­o­gous can­cer vac­cine for prostate can­cer pa­tients who have a high rate of re­cur­rence af­ter prosta­te­c­to­my. The size of the deal was not dis­closed.

In an email to End­points News, Ther­a­gent COO Jeff Mas­ten said the CD­MO was se­lect­ed af­ter a con­sul­tant’s rec­om­men­da­tion.

“Cel­l­Vax se­lect­ing Ther­a­gent for a 230 pa­tient Phase II tri­al pro­vides con­fi­dence and cred­i­bil­i­ty for Ther­a­gent,” Mas­ten said.

The tech trans­fer on the deal has al­ready be­gun and man­u­fac­tur­ing ser­vices are slat­ed to start lat­er this year. Mas­ten said that be­cause the tech trans­fer and oth­er an­a­lyt­i­cal test­ing is a large and time-con­sum­ing ef­fort, it’s like­ly that Ther­a­gent would be “an ob­vi­ous choice” to sup­port a Phase III tri­al if it goes that far.

“Ad­di­tion­al­ly, cell ther­a­py prod­uct com­pa­ra­bil­i­ty across mul­ti­ple man­u­fac­tur­ers is very chal­leng­ing and re­quires FDA ap­proval, there­fore this can all be avoid­ed by stay­ing with one man­u­fac­tur­er for the en­tire clin­i­cal de­vel­op­ment of the prod­uct,” he said.

Ox­ford Bio­med­ica moves to com­plete the sale of its Win­drush Court fa­cil­i­ty

The gene and cell ther­a­py com­pa­ny Ox­ford Bio­med­ica has “ex­changed con­tracts” for the sale of its 75,000 square-foot Win­drush Court fa­cil­i­ty to Kadans Sci­ence Part­ner for £60 mil­lion ($70 mil­lion).

The sale of the fa­cil­i­ty, which is in the city of Ox­ford, UK, ex­ceeds the tar­get of­fer fig­ure of £55 mil­lion ($64 mil­lion). For Ox­ford Bio­med­ica, the fa­cil­i­ty sale now puts the com­pa­ny’s cash po­si­tion at over £150 mil­lion ($176.6 mil­lion).

“The pro­ceeds of the trans­ac­tion will en­hance our net cash po­si­tion, pro­vid­ing us with ad­di­tion­al fi­nan­cial flex­i­bil­i­ty as we build our lead­er­ship as an in­no­va­tion-led CD­MO across all vi­ral vec­tors for cell and gene ther­a­py,” said Stu­art Payn­ter, the CFO of Ox­ford Bio­med­ica, in a press re­lease.

In ad­di­tion, Kadans has grant­ed Ox­ford Bio­med­ica an oc­cu­pa­tion­al lease of the prop­er­ty for 15 years at a rent of £3.5 mil­lion ($4.1 mil­lion) per year and ris­ing to £4.7 mil­lion ($5.5 mil­lion) af­ter five years.

Kinde­va Drug De­liv­ery and a for­mer Pfiz­er unit will com­bine in­to one CD­MO

Kinde­va Drug De­liv­ery will soon be merg­ing with Merid­i­an Med­ical Tech­nolo­gies, a for­mer unit of Pfiz­er un­til it was ac­quired by Al­taris in 2021.

Both com­pa­nies will com­bine to func­tion as a sin­gu­lar CD­MO spe­cial­iz­ing in drug de­liv­ery ca­pa­bil­i­ties sur­round­ing drugs that need par­enter­al, in­hala­tion, trans­der­mal and in­tra­der­mal ad­min­is­tra­tion. Merid­i­an CEO Mil­ton Boy­er will be the CEO of the com­bined com­pa­ny. How­ev­er, they will con­tin­ue to op­er­ate as in­de­pen­dent com­pa­nies un­til the deal clos­es. No time­line has been giv­en for clos­ing.

“The in­te­grat­ed, com­ple­men­tary of­fer­ings of Kinde­va and Merid­i­an cre­ate a CD­MO with a broad port­fo­lio of ca­pa­bil­i­ties and pro­pri­etary tech­nol­o­gy plat­forms across mul­ti­ple drug de­liv­ery for­mats, en­abling us to serve cus­tomers and com­mu­ni­ties across mul­ti­ple large and grow­ing end mar­kets,” Boy­er said in a state­ment.

Both com­pa­nies are cur­rent­ly un­der the ban­ner of the health­care in­vest­ment firm Al­taris. Kinde­va was for­mer­ly known as 3M Drug De­liv­ery Sys­tems un­til it was ac­quired from the 3M com­pa­ny in 2020. The com­pa­ny spe­cial­izes in drug-de­vice com­bi­na­tion prod­ucts with a fo­cus on in­hala­tion, trans­der­mal and in­tra­der­mal prod­ucts.

Merid­i­an was ac­quired by Al­taris from Pfiz­er in 2021 and is a man­u­fac­tur­er of au­toin­jec­tors.

WuXi Vac­cines ac­quires a new man­u­fac­tur­ing fa­cil­i­ty in Chi­na

The vac­cine CD­MO WuXi Vac­cines has inked a deal with Har­bour Bio­Med to net one of its man­u­fac­tur­ing fa­cil­i­ties and bring it un­der the WuXi ban­ner.

The 8,500 square-foot fa­cil­i­ties in Suzhou, Chi­na, will be trans­ferred to WuXi Vac­cines and in­cludes 50L, 500L, and 1000L sin­gle-use biore­ac­tors as well as lines for man­u­fac­tur­ing ster­ile drug prod­ucts. The com­pa­ny al­so plans to ren­o­vate the fa­cil­i­ty and will serve as WuXi Vac­cine’s first stand­alone man­u­fac­tur­ing site in Chi­na.

“The new fa­cil­i­ty will ex­pand our ca­pa­bil­i­ties and ca­pac­i­ties to bet­ter serve our glob­al part­ners in de­vel­op­ing and man­u­fac­tur­ing vac­cines. We are com­mit­ted to ad­vanc­ing the ac­ces­si­bil­i­ty and af­ford­abil­i­ty of high-qual­i­ty vac­cines, with in­te­grat­ed tech­nol­o­gy plat­forms that en­able our glob­al part­ners to en­hance the well-be­ing of peo­ple world­wide,” said Jian Dong, CEO of WuXi Vac­cines, in a press re­lease.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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As the amox­i­cillin short­age drags on, sev­er­al sen­a­tors pres­sure FDA and HHS for so­lu­tions

With the US staring down several drug shortages this year, one in particular is now catching lawmakers’ attention.

A bipartisan group of senators sent a letter to HHS Secretary Xavier Becerra and FDA commissioner Robert Califf expressng “strong concern” about the amoxicillin shortage for patients and general public health. Sens. Amy Klobuchar (D-MN), Sherrod Brown (D-OH), Ed Markey (D-MA) and Bill Cassidy (R-LA) are pushing for FDA and HHS to start working more forcefully to address the amoxicillin shortage along with the other drug shortages.