JNJ's dual-targeting CAR-T shows first encouraging results in large B-cell lymphoma

Despite the transformative potential of cell therapy, only about 2 in 10 eligible patients receive it, due to the confluence of complex logistical and geographic barriers affecting patients and providers. BMS is committed to a long-term goal of expanding access to cell therapy and supports today’s class-wide label updates that will help ease known barriers to treatment and administration while maintaining patient safety. Across both labels, the FDA has approved the reduction or removal of specific patient monitoring requirements for Breyanzi and Abecma. These prolonged requirements posed burdens on healthcare delivery systems and for certain patients and their care partners, particularly those who live far from certified cell therapy treatment centers. The FDA has also approved removal of the REMS requirement from each product label. A REMS program is often required to help mitigate known or potential risks associated with new drugs or therapies. The FDA has since determined that the established management guidelines and extensive experience of the medical hematology/oncology community are sufficient to diagnose and manage the risks of side effects, including cytokine release syndrome (CRS) and neurologic toxicities (NTs), without a REMS for the class of CD19- and BCMA-directed autologous CAR T cell therapies. This change is likely to help further accelerate cell therapy into the community center setting. 

JNJ's dual-targeting CAR T-cell therapy shows encouraging first results in large B-cell lymphoma

JNJ announced the first clinical data from an ongoing Phase 1b study for JNJ-90014496 (JNJ-4496), an investigational dual-targeting anti-CD19/CD20 bispecific autologous CAR T-cell therapy, being studied in patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) who have not been previously treated with CAR T-cell therapy. Findings demonstrate the potential of JNJ-4496 in the treatment of patients with R/R LBCL, including R/R diffuse large B-cell lymphoma (DLBCL) – the most common type of aggressive lymphoma, a blood cancer that originates in the lymphatic system. JNJ-4496, formerly known as C-CAR039, is a dual-targeting CAR T designed to bind to both CD19 and CD20 antigens — two cell surface proteins commonly expressed on malignant B-cells. This design, including a 4-1BB costimulatory domain, is intended to enhance binding strength and persistence, also potentially addressing common mechanisms of resistance in relapsed or refractory disease. In the Phase 1b dose confirmation study in patients with R/R LBCL, data at the recommended Phase 2 dose (RP2D) were reported in patients with a median follow-up of 4 months. Results informed a RP2D of JNJ-4496 at 75 million CAR+ T-cells. Among the 22 patients in the RP2D group where efficacy was assessed, those who received one prior line of therapy (n=10) had an ORR of 100 percent and a CRR of 80 percent (95 percent CI, 69, 100). In the patients who had received two or more prior lines of therapy (n=12), the ORR was 92 percent and the CRR was 75 percent (95 percent CI, 62, 100). 

DEALS AND FINANCING 

NanoCell secured seed-extension financing to advance clinical candidate for B cell malignancies 

NanoCell Therapeutics announced the successful closing of a seed-extension financing round, with participation from The Institute for Follicular Lymphoma Innovation (IFLI), a leading non-profit organization dedicated exclusively to funding innovative follicular lymphoma research and development. The funding will accelerate IND-enabling development of NanoCell’s lead clinical candidate, NCTX-01, a dual-CAR CD19/CD22 in vivo CAR-T therapy for B cell malignancies. NanoCell will use the capital to further evaluate NCTX-01’s safety, efficacy and durability in treating aggressive forms of lymphoma, including diffuse large B-cell lymphoma and follicular lymphoma. NanoCell is a privately held, transatlantic biotechnology company with locations in Wayne, Pennsylvania, and Utrecht, the Netherlands. The company is dedicated to pioneering transformative in-vivo cell engineering through its non-viral, DNA-based gene therapy platform, primarily targeting oncology and autoimmune diseases. By leveraging a proprietary targeted lipid nanoparticle delivery platform, NanoCell is addressing key limitations of traditional CAR-T therapies, including high manufacturing costs, complex logistics and limited accessibility. The company’s approach aims to deliver one-time, off-the-shelf treatments for cancer and autoimmune diseases, with the potential to reach broader patient populations.