CAR-T

Artiva Biotherapeutics is hoping its NK cell therapy approach, which uses un-engineered cells, will prove effective in both oncologic and autoimmune indications and safe enough to be given in the community setting.

Rimqarto is poised to become the first homegrown South Korean CAR-T therapy to gain domestic approval and looks set to provide new local competition to Kymriah.

The TCR therapy showed strong efficacy and durability in patients with previously treated melanoma. A Phase III pivotal trial is due to start in December.

With more advanced therapies gaining approval, companies at ARM’s Cell and Gene Meeting on the Mesa considered hurdles to making their products more broadly available and developing them for larger indications.

An upfront payment of $110m from BMS has come just in time for Prime Medicine, but its real test will be the first Phase I data, expected early next year.

New data from CARTITUDE-4 show a survival benefit in patients with lenalidomide-refractory patients as early as the second line, along with Carvykti being studied for frontline use.

The companies said they would stop enrollment in the KarMMa-9 trial of Abecma/lenalidomide due to how the treatment paradigm has shifted since the study started.

The company’s investment in oncology is starting to pay off, with its PD-L1/VEGF inhibitor BNT324 generating particular interest at ESMO.

Regulators in Europe and the US have demonstrated a commitment to providing guidance that will make decentralized and point-of-care manufacturing a reality, the CSO of GermFree, a company that provides mobile and modular cleanrooms for manufacturing advanced therapies, tells the Pink Sheet.

In this week's podcast edition of Five Must-Know Things: summer ADC dealmaking continues apace; a look at cell therapies in Japan; Pfizer’s new US digital consumer platform; Galapagos’s US point of care CAR-T study; and Novartis partners with Lindy on biologics delivery.