Michael Chambers & John Ballantyne, Aldevron co-founders

Alde­vron and In­scrip­ta ink man­u­fac­tur­ing deal for CRISPR Type-V nu­cle­ase

A plan to broad­en ac­cess to CRISPR has at­tract­ed a chunk of fund­ing and is now see­ing its wings spread.

Far­go-based DNA and mR­NA pro­duc­er Alde­vron has signed an agree­ment with life sci­ences com­pa­ny In­scrip­ta to man­u­fac­ture and com­mer­cial­ize the Eu­re­ca-V Nu­cle­ase, a wild-type MAD7 CRISPR Type-V nu­cle­ase.

This part­ner­ship will aim to of­fer this nu­cle­ase as a stan­dard re­search-grade and GMP cat­a­log item. Ac­cord­ing to a press re­lease, the pro­duc­tion of Eu­re­ca-V is slat­ed to start in Q3 of 2022. Fi­nan­cial de­tails of the deal were not im­me­di­ate­ly made avail­able to End­points News.

This li­cense al­so ex­pands ac­cess to high-qual­i­ty CRISPR reagents, en­abling clients to re­ceive ac­cess to and trans­late their re­search in­to cell ther­a­pies, es­pe­cial­ly al­lo­genic cell treat­ments. The MAD7 is billed by In­scrip­ta as a syn­thet­ic en­zyme and may serve as an al­ter­na­tive to Cas9 that is free for sci­en­tif­ic re­search, with­out the li­cens­ing fee tied to the orig­i­nal CRISPR mol­e­cule.

“Eu­re­ca-V will be our third GMP CRISPR nu­cle­ase and the first Type-V nu­cle­ase avail­able as a GMP cat­a­log prod­uct, en­abling ac­cess to a clin­i­cal-grade reagent in a frac­tion of the time and the cost of man­u­fac­tur­ing a cus­tom batch. By of­fer­ing an iden­ti­cal prod­uct at re­search grade, clients can ex­pect a smooth tran­si­tion from proof of con­cept all the way to the clin­ic,” said Tom Foti, VP of Alde­vron’s pro­tein busi­ness unit.

Alde­vron is al­ready in a strong po­si­tion as one of the top man­u­fac­tur­ers of plas­mid DNA, mR­NA and pro­teins. The com­pa­ny al­so is a sup­pli­er for a host of gene and cell ther­a­py, and gene edit­ing play­ers.

In­scrip­ta has been scal­ing heav­i­ly in the gene edit­ing field. The Boul­der biotech re­ceived a to­tal of $260 mil­lion in their var­i­ous fundrais­ings and an­oth­er $150 mil­lion from in­vestors in 2021 for their en­gi­neer­ing plat­form around the MAD7.

For Alde­vron, this is an­oth­er feath­er in its cap as it con­tin­ues to grow. In 2021, Dana­her struck a deal to pur­chase the com­pa­ny for the price of a $9.6 bil­lion cash deal but act as an in­de­pen­dent unit. Alde­vron’s ma­jor­i­ty own­er used to be EQT Pri­vate Eq­ui­ty, which in­vest­ed in the com­pa­ny along­side its founders.

Alde­vron ex­pand­ed its ca­pa­bil­i­ties in Far­go to in­clude 189,000 square feet of man­u­fac­tur­ing, ware­house, and lo­gis­ti­cal space. Ear­ly in 2021, the com­pa­ny al­so com­plet­ed a ren­o­va­tion and ex­pan­sion project in Madi­son, Wis­con­sin.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.