Man­u­fac­tur­ing roundup: Lon­za fin­ish­es ex­pand­ing Visp site; CBM to pro­duce jCyte’s cell ther­a­py

Lon­za has opened the doors to an ex­pan­sion at one of its pri­ma­ry lo­ca­tions.

The ex­pan­sion oc­curred at Lon­za’s high­ly po­tent API (HPA­PIs) suite at its core man­u­fac­tur­ing site in the city of Visp, Switzer­land. The ex­pan­sion adds room for the de­vel­op­ment and man­u­fac­tur­ing of Lon­za’s ADC prod­ucts, which are be­com­ing more pop­u­lar.

“We ex­pand­ed our HPA­PI ca­pa­bil­i­ties at our Visp site to meet the grow­ing de­mand for AD­Cs. This de­mand is dri­ven by the need for im­proved an­ti­cancer ther­a­peu­tics with few­er side ef­fects. Al­though every com­po­nent of the ADC is es­sen­tial to its ther­a­peu­tic ac­tiv­i­ty, the pay­load is the one that kills can­cer cells.

“These pay­loads are al­most al­ways small mol­e­cule high­ly po­tent APIs,” said Gio­van­na Li­bralon, se­nior di­rec­tor for com­mer­cial de­vel­op­ment of small mol­e­cules at Lon­za in a state­ment to End­points News.

While the ex­act cost and size of the fa­cil­i­ty were not dis­closed to End­points, Li­bralon did state that the project is ex­pect­ed to gen­er­ate more jobs, how­ev­er, no hard num­bers were giv­en.

The Cen­ter for Break­through Med­i­cine to man­u­fac­ture jCyte’s cell ther­a­py

The Cen­ter for Break­through Med­i­cine (CBM), a CD­MO spe­cial­iz­ing in cell and gene ther­a­py, has land­ed a mul­ti-year con­tract to pro­duce jCyte’s cell ther­a­py.

The deal will have CBM pro­duce the ma­te­ri­als for the biotech’s Phase III and man­u­fac­ture the project once it gets BLA ap­proval. It will al­so pro­vide CMC work for jC­tye as it goes through the reg­u­la­to­ry and com­mer­cial phas­es for its treat­ment.

The biotechs ther­a­py is de­signed to treat pa­tients with re­tini­tis pig­men­tosa (RP), a rare ge­net­ic dis­ease main­ly found in chil­dren that can lead to vi­sion loss. The ther­a­py al­so has an RMAT des­ig­na­tion from the FDA.

“We have made tremen­dous progress in ad­vanc­ing our in­no­v­a­tive cell ther­a­py pro­gram to this key stage of clin­i­cal de­vel­op­ment, and CBM’s broad man­u­fac­tur­ing ca­pa­bil­i­ties, ded­i­cat­ed and ex­pe­ri­enced team, flex­i­bil­i­ty to fit our needs, and abil­i­ty to pro­vide ful­ly ded­i­cat­ed man­u­fac­tur­ing suites and an­a­lyt­i­cal test­ing ser­vices tai­lored to our fi­nal drug man­u­fac­tur­ing process made them an ide­al part­ner to sup­port our pro­gram,” said Shan­non Blalock, jCyte CEO in a state­ment.

More funds go­ing to­ward large-scale cell and gene ther­a­py man­u­fac­tur­ing in Cana­da

Man­u­fac­tur­ers in Cana­da are re­ceiv­ing a fund­ing boost to get cell and gene ther­a­py man­u­fac­tur­ing on a wider scale.

Next Gen­er­a­tion Man­u­fac­tur­ing Cana­da (NGen) will con­tribute $10.5 mil­lion to a $34.8 mil­lion project led by Om­ni­aBio and its part­ners. The project aims to de­vel­op tech­nolo­gies for the man­u­fac­tur­ing of cell and gene ther­a­pies in Cana­da and five biotechs have been brought on to the ini­tia­tive.

The project is de­signed to have part­ner­ing com­pa­nies ad­vance cell and gene ther­a­py pro­grams to move to com­mer­cial pro­duc­tion. The ef­fort will try to prove that Cana­da can han­dle large-scale cell and gene ther­a­py man­u­fac­tur­ing. How­ev­er, the part­ner­ship has not dis­closed when pro­duc­tion is ex­pect­ed to progress for­ward.

The in­vest­ment will how­ev­er pro­vide a re­source to pro­vide train­ing in this par­tic­u­lar kind of man­u­fac­tur­ing to the wider work­force.

“This in­vest­ment in crit­i­cal bio­man­u­fac­tur­ing in­fra­struc­ture en­sures that we will be able to lever­age our strengths in re­search and tech­nol­o­gy, build a work-ready tal­ent pipeline, and pro­vide the right con­di­tions for our do­mes­tic CGT ven­tures to scale up in Cana­da,” said Jayson My­ers, CEO of NGen, in a state­ment.

Om­ni­aBio an­nounced ear­li­er this year that it is build­ing a $580 mil­lion cell and gene ther­a­py man­u­fac­tur­ing cen­ter in Hamil­ton, On­tario.

Ther­mo Fish­er part­ners up with a re­gion­al or­ga­ni­za­tion to in­crease life sci­ences in the Philadel­phia area

While Ther­mo Fish­er has been busy open­ing new plants, its next move sees it part­ner­ing to in­vest in fu­ture life sci­ence ini­tia­tives.

The com­pa­ny has part­nered with the Penn­syl­va­nia Biotech­nol­o­gy Cen­ter (PABC) to spon­sor its new cam­pus in Doylestown, PA, a sub­urb of Philadel­phia. Ther­mo Fish­er will pro­vide ex­per­tise and tech­nol­o­gy to biotechs at the cam­pus and an­oth­er in­cu­ba­tor run by PABC.

“Through their in­cu­ba­tor sites, PABC can ac­cel­er­ate the path to com­mer­cial­iza­tion, and our in­vest­ment en­sures that these com­pa­nies start with the com­mer­cial-scale tech­nolo­gies and work­flows that will be re­quired as they move from R&D to the clin­ic,” said Ab­hi­nav Akhoury, VP of cor­po­rate ac­counts at Ther­mo Fish­er, in a state­ment.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

Andrew Crockett, KalVista CEO

KalVista ends a PhII study ear­ly af­ter pa­tients suf­fer se­vere and life-threat­en­ing side ef­fects

KalVista took a beating Tuesday after announcing it would scrap a Phase II trial for one of its experimental drugs.

The biotech said in an early morning press release that it is terminating the study for KVD824 after multiple patients in every treatment group saw unsafe, elevated levels of certain liver enzymes. By ending the trial now, KalVista hopes to save some money and funnel it toward another study for its lead program, CEO Andrew Crockett said in a statement.

Pen­ny stock play­er to re­view all op­tions to try stay­ing afloat af­ter clin­i­cal tri­al fail

Adamis Pharmaceuticals is slowly tumbling down, and the biotech is looking at all its options.

After a Phase II/III trial failure last month that sent the penny stock player down an additional 50% to just 15 cents a share, the company said Monday that it is examining options to get the best value for its investors. A statement from Adamis indicates that alternatives include anything from a partnership to a sale of Adamis’ two commercial products, Zimhi and Symjepi.