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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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Vikram Sheel Kumar, Clear Creek Bio CEO

In search for next-gen Covid treat­ment, Pfiz­er taps tiny biotech for re­search deal

Pfizer has inked a deal to develop a new Covid therapy with Clear Creek Bio — a 10-person biotech out of RA Capital with an office in Cambridge, MA, but one that operates fully remotely.

Paxlovid has become a big moneymaker for Pfizer this year, projecting $22 billion in sales on the year. But the Big Pharma has begun its search for a next-generation Covid antiviral and potential combination therapies as supply of Paxlovid greatly eclipses actual use of the antiviral.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Enhertu researcher Ian Krop speaks during Wednesday's SABCS press conference (MedMeetingImages/Todd Buchanan via SABCS)

SABCS roundup: No­var­tis shows two-year PFS in breast can­cer sub­groups; As­traZeneca re­veals more En­her­tu da­ta

The San Antonio Breast Cancer Symposium is taking place this week, and so far, some of the Big Pharmas are turning out new trial data about some of the biggest drugs in the space.

First off, Novartis announced that its drug, Kisqali, showed about a year of progression-free survival in patients with different types of first-line metastatic breast cancer. The CDK 4/6 drug was first approved by the FDA in 2017, setting it up in direct competition against Pfizer’s Ibrance.