Nanobiotix updates activities and financial results, with positive outcomes for NBTXR3 development.

From GlobeNewswire: 2024-09-18 16:15:00

Nanobiotix’s NBTXR3 activated by radiotherapy followed by an anti-PD-1 showed favorable safety profile, disease control, and tumor response in patients naïve and resistant to anti-PD-1, suggesting its potential to prime the immune system before checkpoint inhibitor therapy. Clinical development milestones expected in the next 12-18 months include new data in pancreatic cancer and head and neck cancers, as well as initial data in esophageal and lung cancers. As of June 30, 2024, the company had €66.3 million in cash and cash equivalents, with cash visibility extended until the fourth quarter of 2025. Nanobiotix is focused on advancing its nanoparticle-based therapeutic approach with NBTXR3, which has an exclusive global licensing agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company, to address significant market opportunities in solid tumors, starting with lung cancer and head and neck cancers. The potential of NBTXR3 to initiate immune activity before anti-PD-1 inhibition has been further strengthened by new data, with several clinical development milestones expected in the next 12-18 months to advance and expand the potential patient population for NBTXR3, including new data in pancreatic cancer and head and neck cancers, as well as initial data in esophageal and lung cancers. Key highlights of the first half of 2024, pipeline status, and expected milestones include strengthening the supervisory board with the appointments of Dr. Margaret A. Liu and Ms. Anat Naschitz as observers, significant operational progress related to NANORAY-312 as part of the global exclusive co-development and commercialization licensing agreement with Janssen Pharmaceutica NV, and advancements in studies for head and neck cancer. Initiatives such as NANORAY-312, a Phase 3 pivotal randomized trial evaluating NBTXR3 activated by radiotherapy with or without cetuximab, are generating promising data for various cancers. For instance, initial results from Study 1100 showed that NBTXR3 activated by radiotherapy followed by an anti-PD-1 was feasible and well tolerated in heavily pretreated head and neck cancer patients, with significant Disease Control Rate and Overall Response Rate observed, supporting further evaluation in randomized clinical trials. Expansion of NBTXR3 development is ongoing through collaborations with MD Anderson Cancer Center to validate its potential as a treatment targeting all solid tumors and therapeutic combinations. Multiple clinical trials are underway in advanced solid tumors, including lung cancer, head and neck cancer, esophageal cancer, and pancreatic cancer, with various developmental stages and interim data expected in the coming months and years.



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