DONGTAN, KOREA, October 7, 2024 - iLeadBMS, a spin-off biotech from Ildong Pharmaceutical Group, announced that it has received a notification from the US Food and Drug Administration (FDA) that its Cyclin-K Molecular Glue (MG), has been granted Orphan Drug Designation (ODD) for gastric cancer.
iLeadBMS’ Cyclin-K MG program is a type of Target Protein Degrader (TPD) that 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 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 in the in vitro experiments. Based on these results, the FDA granted ODD for gastric cancer.
iLeadBMS CSO Dr. Yoon-seok Lee said, “In addition to the MG program, iLeadBMS is also developing a ‘Degrader-Antibody Conjugate’ (DAC) therapeutic against the same Cyclin-K protein. By pursuing the DAC modality, treatment effectiveness can be maximized while the potential side effects are minimized, and this would be the 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 to pursue 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/.
