Veru Advances Sabizabulin into Phase 2 After Preclinical Data Shows Activity in Daraxonrasib-Resistant Pancreatic Cancer

Resistance to daraxonrasib (RASONQUE™) may have a clinical answer sooner than anticipated: Veru Inc. has confirmed a planned Phase 2 trial for oral sabizabulin in metastatic KRAS-driven pancreatic cancer following preclinical data demonstrating the agent retains potent anticancer activity in daraxonrasib-resistant cell lines. For oncology pipeline teams and CMC leads, the data shift sabizabulin from a prostate cancer asset into a resistance-mechanism play with direct implications for manufacturing readiness and clinical supply planning.

The preclinical work, completed in August 2026, used 2D proliferation assays across two KRAS-mutant cell lines: pancreatic AsPC-1 (G12D) and colon HCT-116 (G13D). Daraxonrasib-resistant pancreatic cells showed a resistance index of 68 against daraxonrasib itself, yet exhibited collateral sensitivity to sabizabulin with a resistance index of 0.25, indicating increased susceptibility. The colon cancer line retained sensitivity at a resistance index of 1. Critically, sabizabulin's IC50 of 18.2 nM in the resistant pancreatic line falls within concentrations achievable at current human dosing levels, a threshold already established in a completed Phase 1b/2 study of 80 subjects with castration-resistant, taxane-resistant metastatic prostate cancer.

The mechanism driving daraxonrasib resistance in both cell lines was confirmed as reactivation of the KRAS signaling pathway. Sabizabulin's activity against that reactivated pathway, rather than the original KRAS inhibition target, is what underpins Veru's rationale for the Phase 2 advancement. The company holds IP protection on sabizabulin through 2043 and retains global development and commercialization rights, removing licensing complexity from the supply chain equation.

For plant heads and QA directors tracking clinical supply obligations, Veru's parallel pipeline adds a near-term manufacturing coordination point. The company's enobosarm program, targeting weight loss in older patients on GLP-1 receptor agonists, is operating under a clinical supply agreement with Novo Nordisk and is on track for a Phase 2b PLATEAU trial interim analysis in Q1 2027. A newly issued patent extends enobosarm IP with GLP-1 RA co-administration through late 2044. Managing two clinical-stage assets under separate supply arrangements will test Veru's CMC infrastructure across concurrent trial timelines.

The Phase 2 design and enrollment timeline for sabizabulin in daraxonrasib-resistant pancreatic cancer have not yet been disclosed; protocol finalization and IND alignment with 21 CFR Part 312 requirements will be the next measurable checkpoint for regulatory affairs teams monitoring this program.

Source: Veru Inc. press release via GlobeNewswire, September 8, 2026.