On 12 October 2021, BioNova Pharmaceuticals Ltd. and Sutro Biopharma, Inc. (NASDAQ: STRO) entered into collaboration to develop and commercialize BN301(STRO-001), for patients with hematologic cancers in Greater China.
BN301 is a CD74-targeting ADC, based on Sutro’s integrated cell-free protein synthesis and site-specific conjugation platform, XpressCF+™, currently being investigated in a Phase 1 clinical trial in US. Sutro is currently enrolling patients with multiple myeloma and non-Hodgkin’s lymphoma in a dose-escalation trial and the maximum tolerated dose has not yet been reached. BN301 was granted Orphan Drug Designation by the FDA for multiple myeloma in October 2018.
BioNova obtained IND clearance for the treatment of hematologic maliganncies in Sep 2022. First patient was dosed in a Phase 1/2 study for the treatment of hematoligic malignancies in Feb 2023.
BN104 is a novel, potent and highly selective small molecule menin inhibitor for potential treatment of acute leukemias with rearranged mixed lineage leukemia (MLLr) gene. It showed optimized drug-like properties and excellent efficacy in MV4-11 xenograft mouse model. Furthermore, BN104 has low risk in corrected QT interval (QTc) prolongation given the fact that it is an extremely weak human ether-a-go-go related gene (hERG) inhibitor with IC50 of greater than 100 uM. To date, BN104 has demonstrated favorable toxicity profile in preliminary preclinical studies and is on track for IND filing in May.