Gilead brings Medicxi’s tiny Gade­ta in­to the cell ther­a­py fold, hunt­ing a way to pick the lock on sol­id tu­mors

The bat­tle­ship Gilead has added a small but po­ten­tial­ly re­mark­able biotech tug boat to its fast-grow­ing cell ther­a­py drug fleet.

The bio­phar­ma pow­er­house’s CAR-T com­pa­ny Kite is al­ly­ing with tiny Gade­ta in the Nether­lands, ink­ing a deal to col­lab­o­rate on its gam­ma delta TCR tech, fund­ing re­search and lin­ing up an op­tion to buy them out if it all works out.

Gio­van­ni Marig­gi

De­tails are scant. Gade­ta was seed­ed by Medicxi out of Lon­don, which al­so joined Bax­al­ta Ven­tures on a slim $8 mil­lion launch round in 2016. Now with a staff in the 20s, Gade­ta is still pre­clin­i­cal, but lin­ing up a shot at a crit­i­cal hu­man study for sol­id tu­mors in 2020. And Gilead/Kite is hop­ing that Gade­ta — spe­cial­iz­ing in the high­ly spe­cif­ic gam­ma delta field — will open up a world of new op­por­tu­ni­ties in on­col­o­gy.

“By go­ing af­ter gam­ma delta TCRs you’re open­ing up a uni­verse of tar­gets” that are now off the CAR-T radar, says Gio­van­ni Marig­gi, a prin­ci­pal on Medicxi’s ven­ture team. And beat­ing down the hur­dles to sol­id tu­mors re­mains a Holy Grail in the cell ther­a­py field.

“In liq­uid tu­mors things are work­ing,” says Marig­gi. “In this space in gen­er­al the re­al ex­cite­ment is the sol­id tu­mor part of the sto­ry.”

Alessan­dro Ri­va

Gilead’s can­cer R&D chief Alessan­dro Ri­va not­ed that the com­pa­ny has been ea­ger to snap up new tech plat­forms as it grows its cell ther­a­py di­vi­sion at Kite. And their in­volve­ment here is an­oth­er sig­nal that more deals are com­ing.

Gilead is bet­ting its cash on the orig­i­nal re­search of Jür­gen Kuball, the chief sci­en­tif­ic of­fi­cer of Gade­ta, who al­so works at the Uni­ver­si­ty Med­ical Cen­ter Utrech.

Jür­gen Kuball

This deal rep­re­sents ex­act­ly where Medicxi’s David Grainger likes to play. They love to iden­ti­fy new tech, come up with a bud­get plan to ex­e­cute on re­search, and see if one of the ma­jor play­ers will rec­og­nize the up­side of what they’re do­ing. It’s a world away from the mega-rounds that have been pump­ing in­to biotech star­tups over the past year.

“We make our dol­lars go a lit­tle fur­ther,” says Marig­gi with a chuck­le. And in this case, that strat­e­gy has worked like a charm.

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.

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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.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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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.

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.

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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.

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.

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EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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