M2N US Joint Venture Investee Pasilex Receives FDA Phase 1 Approval for Leukemia Treatment 'PCLX-001'

[Asia Economy Reporter Lee Gwan-ju] M2N announced on the 9th that Pasillex, invested by the US joint venture Greenfire Bio, received approval from the US Food and Drug Administration (FDA) for the clinical trial application (IND) of 'PCLX-001,' which is being developed as a treatment for acute myeloid leukemia (AML).

PCLX-001 is an N-myristoyltransferase inhibitor (NMT inhibitor) and is the world's first and only new drug candidate currently undergoing clinical trials. It is currently being studied in four hospitals in Canada targeting patients with non-Hodgkin lymphoma (NHL) and solid tumors. Following this IND approval, clinical trials for acute myeloid leukemia will be conducted in the US after Canada.

The phase 1 clinical trial for PCLX-001 will be conducted at the MD Anderson Cancer Center, the largest cancer center in the US. M2N has once again established a connection with MD Anderson Cancer Center, following the phase 1 clinical trial of 'GRN-300,' a new drug candidate from Greenfire Bio for ovarian cancer treatment.

An M2N official explained, "Pasillex confirmed through preclinical studies that not only non-Hodgkin lymphoma but also acute myeloid leukemia can respond sensitively to NMT inhibitors, and based on this, we received the IND approval."