Immunocore CEO Bahija Jallal (L) and Gadeta CEO Marcel Zwaal

In search for a 'u­ni­ver­sal T cell en­gager', Im­muno­core inks deal with Gilead-backed Gade­ta

Im­muno­core, which be­came the first com­pa­ny to win ap­proval for a TCR ther­a­py ear­li­er this year, has penned a deal with gam­ma delta T cell spe­cial­ist Gade­ta to de­vel­op treat­ments for sol­id tu­mors, start­ing with col­orec­tal can­cer.

David Berman

Im­muno­core R&D head David Berman told End­points News the deal is part of the com­pa­ny’s ef­forts to de­vel­op a “uni­ver­sal T cell en­gager.” TCR ther­a­pies made from typ­i­cal T cells, like Im­muno­core’s TCR ther­a­py Kimm­trak, are re­strict­ed to pa­tients with cer­tain HLA types, a kind of mark­er that helps the body sep­a­rate friend and foe. Kimm­trak, for in­stance, is in­di­cat­ed on­ly for pa­tients with un­re­sectable or metasta­t­ic uveal melanoma, a rare form of can­cer that hap­pens in the eye, who have the tis­sue type HLA-A*02:01, one of the more com­mon HLA types which by Berman’s es­ti­mate in­cludes around 40-50% of the pop­u­la­tion.

But un­like typ­i­cal T cells, gam­ma delta T cells have unique re­cep­tors and can rec­og­nize and kill cells in­de­pen­dent of HLA type. So a T cell ther­a­py made from gam­ma delta T cells wouldn’t be re­strict­ed to a cer­tain pa­tient pop­u­la­tion.

Im­muno­core and Gade­ta will work to­geth­er to re­search a gam­ma delta TCR in Gade­ta’s port­fo­lio, which rec­og­nizes a spe­cif­ic “alarm sig­nal” on a can­cer cell’s sur­face. Berman said that Gade­ta iden­ti­fied the gam­ma delta T cell from a pa­tient, but the two com­pa­nies have to first “de­con­vo­lute ex­act­ly what the tar­get is” for that gam­ma delta T cell. And be­cause of that, Berman hes­i­tat­ed to put an ex­act time­line on the de­vel­op­ment of a ther­a­py out of this col­lab­o­ra­tion.

But based on that work, Im­muno­core has the op­tion to de­vel­op a gam­ma delta ver­sion of a bis­pe­cif­ic T cell en­gager, or BiTE.

While Berman de­clined to dis­close fi­nan­cial de­tails in an in­ter­view with End­points, he said the struc­ture of the deal was like most oth­ers. Gade­ta is el­i­gi­ble for an up­front op­tion and down­stream re­search mile­stone pay­ments. And if Im­muno­core goes for the ex­clu­sive li­cense on a treat­ment de­vel­oped from the col­lab­o­ra­tion, Gade­ta can get de­vel­op­ment and com­mer­cial mile­stone pay­ments as well as roy­al­ties on the ther­a­py.

Gade­ta, based in the Nether­lands, is al­ready de­vel­op­ing a ther­a­py dubbed GDT201 based on that sig­nal, which it will re­tain own­er­ship of in the deal. It is plan­ning a Phase I tri­al for that can­di­date, which it says is slat­ed to start in the sec­ond half of 2023. Gade­ta’s method en­gi­neers nor­mal T cells with the re­cep­tor of a gam­ma delta T cell. Its lead can­di­date, GDT002, is al­ready in clin­i­cal tri­als for re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma and ovar­i­an can­cer, ac­cord­ing to Gade­ta’s web­site.

Aside from Gade­ta, there are a hand­ful of oth­er biotechs work­ing with gam­ma delta T cells, in­clud­ing IN8bio, Gam­maDelta, and Adicet Bio.

Im­muno­core has pre­vi­ous­ly worked on de­vel­op­ing a uni­ver­sal T cell en­gager as well, through fund­ing from a tu­ber­cu­lo­sis re­search project from the Bill & Melin­da Gates Foun­da­tion. That re­search fo­cused on a non­tra­di­tion­al HLA mol­e­cule known as HLA-E, which is rec­og­nized by nat­ur­al killer cells.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Alon Seri-Levy, Sol-Gel Technologies CEO

Bridge­Bio com­pa­ny sells off rare dis­ease can­di­date to Gal­der­ma part­ner

Israeli biotech Sol-Gel Technologies announced Friday that it got its hands on a rare disease drug candidate from PellePharm for almost $75 million, amid claims that the drug has the potential to reach a $300 million market.

Execs said on a conference call Friday morning that patidegib, a hedgehog signaling pathway blocker, is being investigated to treat Gorlin syndrome, a rare genetic disorder that increases the risk of developing certain kinds of cancer such as basal cell skin cancer and medulloblastoma, a type of brain cancer. The disease affects around one in every 31,000 people, and an estimated 70,000 people worldwide.

CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.