Man­u­fac­tur­ing roundup: WuXi STA un­veils new fa­cil­i­ty; Pur­due Uni­ver­si­ty nets $3M grant for ze­ro-waste phar­ma man­u­fac­tur­ing

CD­MO WuXi STA has been on the move re­cent­ly by break­ing ground on a fa­cil­i­ty in the US, and the com­pa­ny is show­ing no signs of stop­ping its ex­pan­sion dri­ve.

The com­pa­ny an­nounced that it has opened a new ster­ile lipid nanopar­ti­cle man­u­fac­tur­ing site at its cam­pus in the city of WuXi, Chi­na. The fa­cil­i­ty has a mod­u­lar lay­out, al­low­ing for flex­i­bil­i­ty in the man­u­fac­tur­ing process, and can pro­duce 10 to 50 liters per batch.

“We are pleased to sup­port our part­ners with this state-of-the-art LNP fa­cil­i­ty to meet the grow­ing de­mand for ad­vanced in­jec­tion dosage forms. We will con­tin­ue to ex­pand our CRD­MO plat­form’s ca­pac­i­ty and ca­pa­bil­i­ties to en­able our part­ners to ac­cel­er­ate more in­no­v­a­tive drugs to mar­ket for pa­tients world­wide,” said WuXi STA CEO Minzhang Chen in a state­ment.

Pur­due Uni­ver­si­ty team nets grant to in­ves­ti­gate more sus­tain­able phar­ma­ceu­ti­cal man­u­fac­tur­ing

Re­searchers at Pur­due Uni­ver­si­ty have se­cured a $3 mil­lion grant from the Na­tion­al Sci­ence Foun­da­tion to in­ves­ti­gate cost-ef­fec­tive, ze­ro-waste ini­tia­tives for phar­ma man­u­fac­tur­ing op­er­a­tions.

Ac­cord­ing to the uni­ver­si­ty, cur­rent man­u­fac­tur­ing can cre­ate a sig­nif­i­cant amount of un­used med­i­cines and tox­ic waste, caus­ing en­vi­ron­men­tal dam­age and re­duc­ing man­u­fac­tur­ers’ prof­its.

“Our project is fo­cused on cre­at­ing a large-scale frame­work and cy­ber­in­fra­struc­ture that can help man­u­fac­tur­ing net­works to per­form more sus­tain­ably. We’ll start our proof of con­cept with the phar­ma­ceu­ti­cal in­dus­try, giv­en its high im­pact on the Amer­i­can man­u­fac­tur­ing sys­tem dur­ing Covid,” said Shwe­ta Singh, project leader and as­so­ciate pro­fes­sor of Agri­cul­tur­al and Bi­o­log­i­cal En­gi­neer­ing and En­vi­ron­men­tal and Eco­log­i­cal En­gi­neer­ing, in a state­ment.

The project will aim to build a “cir­cu­lar econ­o­my de­sign com­pu­ta­tion­al tool,” which will help com­pa­nies reuse re­sources while al­so re­duc­ing the flow of waste, and stands in stark con­trast to the more lin­ear forms of pro­duc­tion in the in­dus­try.

The mod­el has al­ready been test­ed in agrar­i­an-based set­tings, and Singh’s team is work­ing with part­ners in the in­dus­try to de­vel­op and test the al­go­rithms.

The team will al­so work to de­vel­op a pric­ing al­go­rithm as well for the re­cy­cling of waste med­i­cines for man­u­fac­tur­ing.

Ori Biotech part­ners up with Re­silience and MD An­der­son joint ven­ture

The joint ven­ture be­tween Re­silience and MD An­der­son to cre­ate a man­u­fac­tur­ing site for cell ther­a­pies has pulled in a new part­ner.

Man­u­fac­tur­ing tech­nol­o­gy com­pa­ny Ori Biotech has part­nered up with the Cell Ther­a­py Man­u­fac­tur­ing Cen­ter (CTMC), the joint ven­ture that aims to cre­ate new cell ther­a­pies to fight can­cer. The col­lab­o­ra­tion will set its sights on in­dus­tri­al man­u­fac­tur­ing process­es for cell ther­a­pies.

Ac­cord­ing to Ori, the part­ner­ship will in­clude com­bin­ing its tech­nol­o­gy plat­form with the man­u­fac­tur­ing cen­ter’s ca­pa­bil­i­ties. While the part­ner­ship has ze­roed in on work­ing on one cell ther­a­py now, it plans to work on oth­er Car-T process­es and de­ter­mine its “tech­ni­cal fea­si­bil­i­ty.”

The part­ner­ship will al­so al­low the CTMC to gain pre-com­mer­cial ac­cess to Ori’s tech­nol­o­gy.

“Ori and CTMC have specif­i­cal­ly part­nered with the goal of in­creas­ing pa­tient ac­cess to po­ten­tial­ly life-sav­ing cell ther­a­pies. This part­ner­ship will have a con­sid­er­able im­pact on the cell ther­a­py field by im­ple­ment­ing in­no­v­a­tive, dig­i­tal­ly en­abled process dis­cov­ery and au­to­mat­ed man­u­fac­tur­ing so­lu­tions,” said Ja­son Fos­ter, Ori Biotech’s CEO, in a state­ment.

Man­u­fac­tur­er ac­quired by Sin­ga­pore-based pri­vate eq­ui­ty firm

Ever­stone Cap­i­tal has ac­quired a con­trol­ling stake in the man­u­fac­tur­ing com­pa­ny Soft­gel Health­care. Soft­gel, an In­di­an-based dosage form man­u­fac­tur­ing op­er­a­tion, cre­ates over-the-counter phar­ma­ceu­ti­cal prod­ucts — main­ly pro­bi­otics and soft gelatin cap­sules.

Ac­cord­ing to Sin­ga­pore-based Ever­stone Cap­i­tal, the ac­qui­si­tion will aim to build up Soft­gel and pro­vide the com­pa­ny with more re­sources. The fi­nan­cial terms of the deal were not dis­closed.

Soft­gel, part of the Madras Phar­ma Group, al­so main­tains eight man­u­fac­tur­ing sites and R&D op­er­a­tions.

“The com­pa­ny, with its strong R&D ca­pa­bil­i­ties and abil­i­ty to man­u­fac­ture prod­ucts in ad­vanced dosage forms, is well po­si­tioned to be a glob­al leader in the CD­MO seg­ment. We be­lieve that Ever­stone’s val­ue cre­ation play­book will help SH­PL re­al­ize its glob­al goals and pro­pel the com­pa­ny in­to its next phase of growth,” said Sameer Sain, Ever­stone Group CEO in a state­ment.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Jerome Durso, Intercept Pharmaceuticals CEO

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

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Bo Cumbo, new Solid Bio CEO

Sol­id Bio gets a new CEO, $75M cash and drops lead drug as big in­vestors ju­ry-rig a merg­er deal

Three months after Endpoints News broke the story that gene therapy outfit AavantiBio had gutted its CMC group in a reorganization, the biotech’s CEO has helped engineer a merger with struggling penny stock player Solid Bio. And he’s going to remain in charge of the combined operation, as Solid founder Ilan Ganot steps aside.

The merger news this morning features some high-profile investors.

Perceptive Advisors, RA Capital Management and Bain Capital Life Sciences are leading a $75 million raise to add to the pool of cash Solid will have after the tie-up. That will leave Solid $215 million in cash as Bain’s Adam Koppel jumps on the board — enough to pay for ops and get through some key data milestones on their way into 2025.

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