As Cu­ria ex­pands, it will add API site in up­state New York; In bat­tle against food al­ler­gies, Al­ladapt to build site to prep for PhI­II tri­als

In Ju­ly, con­tract man­u­fac­tur­er AM­RI re­brand­ed as Cu­ria, and wran­gled two biotechs to aid in its move to­ward glob­al ex­pan­sion. Thurs­day, the com­pa­ny an­nounced that it will up its com­mer­cial man­u­fac­tur­ing at its Rens­se­laer, NY site.

Cu­ria will in­vest more than $35 mil­lion to dou­ble the batch-size scal­ing and pack­ag­ing op­er­a­tions, and al­low Cu­ria to man­u­fac­ture APIs for new prod­ucts.

“Our Rens­se­laer team’s his­to­ry of ex­cel­lence in de­liv­er­ing U.S.-based com­plex man­u­fac­tur­ing so­lu­tions that en­able our cus­tomers to pro­vide vi­tal treat­ments to pa­tients is re­sult­ing in in­creas­ing de­mand,” CEO John Ratliff said in a press re­lease. “Some of the life-sav­ing prod­ucts pro­duced at Rens­se­laer are high­ly com­plex, in­clud­ing crit­i­cal on­col­o­gy ther­a­peu­tics and nov­el treat­ments ad­dress­ing un­met med­ical needs. The en­gi­neer­ing and tech­nol­o­gy ad­vances we have de­signed for the site will en­hance our flex­i­bil­i­ty, ef­fi­cien­cy and scale, al­low­ing us to meet our cus­tomers’ cur­rent and fu­ture com­plex man­u­fac­tur­ing needs.”

The ex­pan­sion will be done with­in the next 18 months, the com­pa­ny said. Cur­rent­ly, there are API man­u­fac­tur­ing sites in France, Spain, In­dia and Italy, in ad­di­tion to the US.

In bat­tle against food al­ler­gies, Al­ladapt to build site to prep for PhI­II tri­als

Al­ladapt Im­munother­a­peu­tics will build a new man­u­fac­tur­ing site to de­vel­op its lead can­di­date, fo­cused on treat­ing IgE-me­di­at­ed food al­ler­gy.

The site will be 53,000 square feet and is lo­cat­ed near Philadel­phia, where the com­pa­ny’s CMO is lo­cat­ed.

The goal is to even­tu­al­ly get full-scale pro­duc­tion ca­pac­i­ty for Phase III tri­als of ADP101. The can­di­date is de­signed to ad­dress the al­ler­gies to foods con­nect­ed with 90% of all food al­ler­gies. Right now, the drug is in Phase I/II tri­als.

“One of the great strengths of Al­ladapt is our tech­ni­cal op­er­a­tions team, which has spent years ad­dress­ing the spe­cial­ized, nov­el chal­lenges as­so­ci­at­ed with pro­duc­ing phar­ma­ceu­ti­cal-grade sin­gle-and mul­ti-al­ler­gen oral im­munother­a­peu­tic agents,” CTO Mike Holfin­ger said in a press re­lease.

Food al­ler­gies to peanuts, tree nuts, fish and shell­fish are as­so­ci­at­ed with fa­tal and near-fa­tal food-in­duced ana­phy­lax­is, and as of now, the best way to treat the al­ler­gy is avoid­ance of the foods, Al­ladapt said.

Ex­pand­ed ca­pac­i­ty com­ing to Rentschler’s Mass­a­chu­setts man­u­fac­tur­ing site

Six months af­ter an­nounc­ing the ad­di­tion of a UK cell and gene ther­a­py man­u­fac­tur­ing site, Ger­man CD­MO Rentschler Bio­phar­ma will ex­pand its Boston pro­duc­tion site in Mil­ford, MA for two new biore­ac­tors and more clean­room space.

The new clean­rooms will add 22,000 square feet of space, and two 2,000 L sin­gle-use biore­ac­tors will cut the com­plex­i­ty of man­u­fac­tur­ing, the com­pa­ny said in a re­lease. The site is ex­pect­ed to be up and run­ning by late 2023.

With the plan comes an ex­pan­sion of qual­i­ty con­trol, de­vel­op­ment and a ware­house. In a press re­lease, CEO Mar­tin Kessler said:

This is a very time­ly step, as the bio­phar­ma CD­MO mar­ket is ex­pect­ed to grow by dou­ble dig­its over the next years, and RBMC US will play a piv­otal role in our plans to con­tin­u­al­ly out­per­form the over­all mar­ket de­vel­op­ment. This new site will dou­ble our com­mer­cial cGMP man­u­fac­tur­ing ca­pac­i­ty. By bring­ing in state-of-the-art tech­nol­o­gy and in­dus­try 4.0 so­lu­tions, RBMC US will strong­ly en­hance our val­ue propo­si­tion in com­mer­cial man­u­fac­tur­ing.

So far, the Mil­ford site has ex­pand­ed from a sin­gle-prod­uct fa­cil­i­ty to one pro­duc­ing sev­er­al prod­ucts with a 500 L biore­ac­tor set­up.

To aid in mR­NA bot­tle­neck, Bio­tage opens site in UK

In an ef­fort to up its mR­NA pro­duc­tion and of­fer off-the-shelf lipids to use in vac­cine pro­duc­tion, Bio­tage will triple its pro­duc­tion ca­pac­i­ty by adding a new site in Cardiff, UK.

The move will help bat­tle the raw ma­te­r­i­al bot­tle­neck that’s been caused by the ramp-up in vac­cine pro­duc­tion that’s come from the Covid-19 pan­dem­ic. The new site is op­er­a­tional as of Mon­day.

“Our cus­tomers need­ed to man­u­fac­ture their prod­ucts on a sig­nif­i­cant­ly larg­er scale, and we were able to in­vest in an ex­pan­sion of our ex­ist­ing pro­duc­tion fa­cil­i­ties to sup­port their re­quire­ments. We were very pleased to be able to de­liv­er this ex­pan­sion in just over four months in or­der to meet the needs of present and po­ten­tial new clients,” EVP An­ders Wik­ström said 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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#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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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.

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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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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Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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