CAR-plus: Irish biotech re­cruits Kite alum Chris Now­ers to prep dual-tar­get­ing NK cell ther­a­py for the clin­ic

Soon af­ter Chris Now­ers left Cell Med­ica — fresh­ly re­brand­ed Ku­ur Ther­a­peu­tics — in Feb­ru­ary, the Kite Phar­ma alum was in­tro­duced to an­oth­er cell ther­a­py play­er.

Chris Now­ers

The ba­sic idea of build­ing an off-the-shelf al­lo­gene­ic plat­form with a CAR-NK ap­proach was fa­mil­iar to him, rid­ing on the same wave as Take­da, J&J-backed Fate, Nkar­ta and oth­ers. But then there was some­thing else that stood out: a mem­brane-bound TNF re­lat­ed apop­to­sis in­duc­ing lig­and vari­ant, or TRAIL vari­ant, that’s al­so en­gi­neered on­to the NK cell for a dual-tar­get­ed at­tack.

It was in­trigu­ing enough for him to take on the CEO role at ONK Ther­a­peu­tics, which is tak­ing the wraps off an $8 mil­lion round de­signed to fund the pre­clin­i­cal work that will pave the way for an IND in two years’ time.

“I’ve had a lit­tle bit of a bap­tism of fire,” he told End­points News.

De­spite not be­ing able to meet Michael O’Dwyer, the CSO and a pro­fes­sor at Na­tion­al Uni­ver­si­ty of Ire­land Gal­way and the team he’s lead­ing there, he added, they have a “great part­ner­ship.”

“Michael knows the sci­ence very very thor­ough­ly,” Now­ers said. “So he’s been send­ing me clin­i­cal pa­pers and da­ta so that I can get up to speed rapid­ly.”

Michael O’Dwyer

The TRAIL vari­ant, ONK’s the­o­ry goes, adds a sec­ond mech­a­nism of cy­to­tox­i­c­i­ty that en­gages the death re­cep­tor path­way and re­mains un­af­fect­ed by anti­gen loss.

Both of the biotech’s lead pro­grams in­cor­po­rate pret­ty stan­dard CARs, the first go­ing af­ter CD19 for re­lapsed/re­frac­to­ry B cell ma­lig­nan­cies and the sec­ond de­ploy­ing an op­ti­mized CD38 CAR to treat pa­tients re­lapsed/re­frac­to­ry mul­ti­ple myelo­ma. Com­ing up be­hind them is a sol­id tu­mor can­di­date that hits MUC1.

This unique CAR-plus ap­proach, Now­ers be­lieve, will be key to a fast fol­low­er like ONK while oth­er com­pa­nies are ex­plor­ing sim­i­lar sci­ence.

Hav­ing built up a team of 8 since 2015, O’Dwyer is look­ing to hire two more sci­en­tists in the Gal­way lab while Now­ers ex­pands the C-suite with a chief op­er­at­ing of­fi­cer, ex­pect­ing rapid growth in the com­ing year.

“Since the ini­tial trans­for­ma­tive da­ta of au­tol­o­gous CAR-T ther­a­py, which re­al­ly was a step change, I think the field is re­al­ly ac­cel­er­at­ing,” he said.

New York-based Acorn Bioven­tures is pro­vid­ing the fu­el for ONK’s next move, along­side cur­rent share­hold­ers in­clud­ing Azur Phar­ma founder Sea­mus Mul­li­gan.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

CEO Khurem Farooq (Gyroscope)

Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

In a surprising turn of events, UK-based Gyroscope Therapeutics has postponed its IPO mere hours before it was set to debut on Nasdaq.

Working on a gene therapy for wet AMD, Gyroscope was all set and ready to go public earlier this week, setting terms for a $142 million raise with a price range of $20 to $22. But in the wee hours of Friday morning, the company put out a press release saying they would delay their debut “in light of market conditions,” CEO Khurem Farooq said in a statement.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

Karyopharm taps long­time Pfiz­er, Am­gen vet to steer the ship; With Mer­ck in the rearview mir­ror, Roger Perl­mut­ter stakes his claim to a CEO job — and it's a sur­pris­ing choice

Like many who work in biopharma, Richard Paulson got started in the field because of a love of science.

Paulson had just finished business school and was looking to start a career that married his two passions. While looking for jobs, he thought of his grandmother who had struggled with Alzheimer’s disease, recalling how he saw first-hand what innovative medicines can do for patients. Ultimately, he started his first job in the space as a sales rep at Glaxo Wellcome, one of GlaxoSmithKline’s predecessors before its merger with SmithKline Beecham in 2000.