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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sanofi scraps PhI­II tri­al for Prin­cip­ia drug af­ter re­view­ing com­pe­ti­tion

Months after the FDA placed Phase III trials of Sanofi’s BTK inhibitor on hold, the company is winding down one of the studies.

Sanofi reported in its Q4 earnings that the URSA study “was discontinued after careful evaluation of the emerging competitive treatment landscape in” myasthenia gravis, a rare disease that causes muscle weakness.

The Phase III, placebo-controlled trial was testing tolebrutinib in patients with the moderate-to-severe form of the disease. It started in late 2021, according to records on clinicaltrials.gov, and was originally designed to recruit 154 participants who were receiving the standard of care.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.