CAMBRIDGE, Mass., July 17, 2026
Anova and Nouveau Biosciences announced a strategic partnership to conduct clinical development of Kromastat (formerly NBS-M001), a novel polymeric nanoparticle-based epigenetic therapy being developed for relapsed or refractory cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). Under the agreement, Anova will manage the delivery of the first-in-human Phase 1 clinical study using its proprietary AnovaOS® technology platform, supporting accelerated development of Nouveau Biosciences’ targeted nanomedicine pipeline.
Phase 1 Study to Evaluate First-in-Class Nanomedicine
The first-in-human Phase 1 study will be conducted at leading academic medical centers across Australia to evaluate the safety and clinical potential of Kromastat, a proprietary polymeric nanoparticle (PNP) formulation of a highly potent epigenetic drug. Preclinical studies have demonstrated promising activity against pancreatic cancer, challenging T-cell malignancies, and aggressive leukemia. Following Phase 1 completion, Nouveau Biosciences plans to rapidly advance the program into U.S. Phase 2 clinical trials using the FDA’s 505(b)(2) regulatory pathway.
AnovaOS Platform Designed to Accelerate Clinical Development
Through the collaboration, Anova will leverage its AnovaOS® clinical development platform to streamline trial execution, improve operational efficiency, and accelerate the advancement of Kromastat. The partnership combines Nouveau Biosciences’ proprietary drug discovery and polymer-based nanochemistry platform with Anova’s technology-enabled clinical research capabilities, aiming to reduce development timelines while enhancing execution quality for innovative oncology therapies.
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Targeted Nanomedicine Platform Focuses on Precision Oncology
Nouveau Biosciences’ proprietary platform integrates advances in cancer biology, genomics, computational biology, and nanomedicine to develop precision-targeted cancer therapies. Its engineered polymer-based nanoparticles are designed to improve drug targeting, tolerability, and therapeutic efficacy by delivering individual drugs or optimized drug combinations directly to tumors. The companies believe this collaboration will accelerate the development of next-generation oncology treatments for patients with significant unmet medical needs while supporting the broader advancement of Nouveau’s nanomedicine pipeline.
Source: Anova press release
