Chris Perkin, Altasciences via Youtube

A year af­ter ex­pan­sion in Penn­syl­va­nia, Al­ta­sciences scoops up CRO to spread to Mid­west

Al­ta­sciences CEO Chris Perkin has gone through sev­er­al ac­qui­si­tions in his 45-year ca­reer. And if there’s one thing he learned, it’s how not to go through an ac­qui­si­tion.

His com­pa­ny put that knowl­edge to use on Tues­day when it an­nounced that it had ac­quired com­peti­tor Sin­clair re­search, a pre­clin­i­cal con­tract re­search or­ga­ni­za­tion in Mis­souri. With the pick­up, Al­ta­sciences gains 80 an­i­mal rooms, and full-ser­vice IND and NDA-en­abling tox­i­col­o­gy and safe­ty phar­ma­col­o­gy ser­vices.

The com­pa­ny has been around for more than 50 years, and Perkin said that the move has felt more like meet­ing up with fel­low col­leagues than ac­quir­ing a new as­set. Sin­clair’s reg­u­la­to­ry his­to­ry is sol­id, he said, and it gives Al­ta­sciences more op­por­tu­ni­ties in the small mol­e­cule mar­ket, which can be of­ten over­looked. That will al­low for a range of dif­fer­ent drug class­es, and broad­en the over­all pre­clin­i­cal of­fer­ings.

“We’ve al­ways been aware of Sin­clair, I mean, that’s a com­peti­tor,” Perkin said. “When it came up for sale…we start­ed talk­ing with the own­ers, and we con­nect­ed along a lot of lev­els. Sim­i­lar cul­ture, sim­i­lar ap­proach to cus­tomer ser­vice. It just gave us so much of a com­fort lev­el that they had al­ready heard of us, it was just more like col­leagues com­ing to­geth­er than form­ing a new com­pa­ny.”

Perkin said that cul­ture was the biggest pri­or­i­ty for the team. If you meet the cur­rent em­ploy­ees where they al­ready are, you can iden­ti­fy strate­gies and meth­ods the team have in place. When you don’t have to change much, morale is kept high.

The lo­ca­tion in Mis­souri al­so stood out to Al­ta­sciences, as it al­ready boasts Wash­ing­ton state and Penn­syl­va­nia sites on ei­ther coast.

“It’s per­fect be­cause it fills a gap, but it’s on­ly a cou­ple of hours, at most from our cam­pus with a clin­i­cal site, which al­ways brings a lot of op­por­tu­ni­ties as we pro­vide this in­te­grat­ed so­lu­tion for drug de­vel­op­ment,” Perkin said.

The ac­qui­si­tion marks the eighth site un­der the Al­ta­sciences um­brel­la. Six of those have come through ac­qui­si­tions, and three of those deals were made in 2021 alone. The com­pa­ny isn’t done ei­ther. The deal fits in­to its long-term growth plan, which is fo­cused on ex­pand­ing both or­gan­i­cal­ly and through ac­qui­si­tions, and stretch­ing its reach ge­o­graph­i­cal­ly. Most press­ing is the com­pa­ny’s move to Eu­rope, which is cur­rent­ly in the works. More con­crete news on that front is ex­pect­ed to be re­leased in the next five to six months, Perkin said.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

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.

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

BREAK­ING: 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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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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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.

FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

As the Office of Tissue and Advanced Therapies (OTAT) transforms into the Office of Therapeutic Products (OTP), with new user fee funds and “super office” status, the department focused on cell and gene therapies also opened its doors to a town hall Thursday offering clarification on guidance and regulations for manufacturers.

Some of the major concerns from manufacturers were the CMC considerations between first-in-human studies and late-phase studies supporting a marketing approval.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

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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