iLeadBMS’ Cyclin-K Molecular Glue Receives ODD from FDA for Gastric Cancer

DONGTAN, KOREA, October 7, 2024

iLeadBMS, a spin-off biotech from Ildong Pharmaceutical Group, announced on the 1st that it has received a notification from the US Food and Drug Administration (FDA) that its Cyclin-K molecular glue, has been granted Orphan Drug Designation (ODD) for gastric cancer.

iLeadBMS’ Cyclin-K molecular glue (MG) program is a type of Target Protein Degrader (TPD), and it targets Cyclin-Dependent Kinase 12 (CDK12), a protein that regulates the expression of genes associated with cancer induction. CDK12 is known to form a complex with Cyclin-K, a protein involved in the cell cycle regulation which affects growth and metastasis of cancerous cells in incurable cancers.

Research results showed that iLeadBMS’ Cyclin-K MG not only binds to CDK12 and effectively inhibits its activity, but also, selectively degrades Cyclin-K using the body’s protein degradation mechanism.

In February of 2024 at ESMO TAT, iLeadBMS had announced its Cyclin-K MG had demonstrated very strong growth inhibition of human epidermal growth factor receptor 2 (HER2) negative gastric cancer cells, through degradation of the target proteins in the in vitro experiments and, ODD for gastric cancer was granted by the FDA based on this data.

An official from iLeadBMS said, “iLeadBMS is also developing a ‘Degrader-Antibody Conjugate’ (DAC) therapeutic against the same Cyclin-K protein as a separate project in addition to the MG program. By pursuing the DAC modality, treatment effectiveness can be maximized while the potential side effects are minimized, and this would be a first time where a Cyclin-K MG is used as a payload for a DAC or ADC.” He added, “we have decided to pursue both modalities targeting the same protein because both MG and DAC can offer distinctive advantages as Cyclin-K protein degraders.”

iLeadBMS plans to initiate the IND-enabling GLP toxicity studies soon and file for IND targeting solid tumors.

About iLeadBMS 

Established in 2020 as a spin-off from Ildong Pharmaceuticals, iLeadBMS specializes in the discovery and development of novel drugs with therapeutic focus in fibrosis, oncology, and neurodegenerative diseases. For more information, please visit https://www.ileadbms.com/.