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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Michael Rome (Foresite)

In search of 'house­hold health­care brands of the fu­ture,' Fore­site Cap­i­tal rais­es $969M to sa­ti­ate a tech-heavy ap­petite

Back in April 2018, just before Foresite Capital unveiled its $668 million Fund IV and a strategy to focus on tech-driven life science bets, one of its portfolio companies quietly made an announcement.

Fount Therapeutics, a drug discovery outfit backed by Foresite and Eshelman Ventures, had raised $22 million in Series A cash to hatch several fledgling spinouts. “The first ‘NewCo,’ Kinnate, will be focused on developing precision oncology treatments,” read a press release.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Masayoshi Son, SoftBank CEO (glen photo/Shutterstock)

Japan's Soft­Bank plots bil­lions in biotech in­vest­ments in move that could keep the val­u­a­tion flood ris­ing — re­port

The valuation crazy train in biotech continues to roll into the new year with more than a dozen companies taking a chance on Nasdaq and money flowing in from all sides. Now, a Japanese institutional investor is reportedly weighing an entry into the market in a big way — will it keep the bitcoin-esque flood rising?

Already a part-time investor in biotech, SoftBank could drop billions of dollars into the industry as part of helmsman Masayoshi Son’s plan to spend around $80 billion of the firm’s own assets, according to a report from Bloomberg citing people familiar with the plan.

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