Mendus has announced an agreement to enable the technology transfer for manufacturing of the company’s lead development program DCP-001 with Minaris Regenerative Medicine.
DCP-001 is currently being evaluated in the ADVANCE II Phase 2 clinical trial to prevent cases of tumor recurrence in Acute Myeloid Leukemia (AML) and in the ALISON Phase 1 clinical trial in ovarian cancer.
“Based on our in-house process development experience and capabilities we have developed a DCP-001 process optimized for large-scale industrial manufacturing. With DCP-001 in Phase 2 development and considering the encouraging data reported so far, it is time to take the necessary steps now and prepare for a transition into late-stage manufacturing infrastructure,” says Leopold Bertea, Chief Technology Officer of Mendus. “We have chosen Minaris as our CDMO and manufacturing partner in consideration of their demonstrated outstanding abilities and track-record, and their focus on the production of cell and gene therapy products.”
Clinical trials updates
Mendus plans to announce updated results and survival outcomes from the ADVANCE II clinical trial evaluating its lead cancer program DCP-001 as a novel AML maintenance therapy in Q4 2022. Positive interim results reported in May 2022 have demonstrated a successful outcome on the primary study endpoint of measurable residual disease (MRD), including first clear signals that MRD responses translate into relevant survival benefit. Mendus will also present first clinical results from the ALISON trial evaluating DCP-001 in ovarian cancer at the European Society of Gynecological Oncology (ESGO) conference, held October 27-30.
Photo of Menus’ management team