mRNA as Epigenomic Controller

mRNA as Epigenomic Controller יִשְׂרָאֵל

Modality

Developed by Omega, the Epigenomic Controller is an mRNA-based therapy programmed to deliver highly specific targeting of unique sequences within the genome, which can controllably modulate gene expression over customized durations to provide options other than "all on" or "all off". Through exerting pre-transcriptional action at the highest levels of gene regulation, mRNA-based controllers are intended to surmount compensatory autoregulation typically linked to key disease drivers, including those that have historically been untreatable by conventional approaches.

As the first-in-class Omega Epigenomic Controller, OTX-2002 is currently being developed for the treatment of hepatocellular carcinoma (HCC). OTX-2002 is intended to regulate the expression level of c-MYC (MYC), utilizing targeted mRNA-encoded proteins to mediate epigenetic regulation with the potential to override MYC autoregulation. The FDA granted Orphan Drug Designation to OTX-2002 in treating HCC.

Other mRNA therapeutics as epigenomic controllers of Omega are being investigated in pre-clinical studies, including OTX-2101 (MYC) for non-small cell lung cancer, CXCL 1-8 for inflammation, HNF4A for liver regeneration, and SFRP1 for alopecia.

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Custom Deliverables

Grade	Deliverables	Specification	Applications
non-GMP	Drug Substance, mRNA	0.1~10 mg (mRNA)	Preclinical research such as cell transfection, Analytical method development, Pre-stability studies, Formulation development
	Drug Product, LNP-mRNA
GMP, Sterility	Drug Substance, mRNA	10 mg~70 g	Investigational new drug (IND), Clinical trial authorisation (CTA), Clinical trial supply, Biologic license application (BLA), Commercial supply
	Drug Product, LNP-mRNA	5000 vials or pre-filled syringes/ cartridges

mRNA Pipelines as Epigenomic Controller

Code Name	Target Gene	Indications	Manufacturer	Latest Stage
OTX-2002	MYC	Hepatocellular carcinoma	Omega Therapeutic	Phase I/II
OTX-2101	MYC	Non-small cell lung cancer	Omega Therapeutic	Pre-clinical
CXCL 1-8	CXCL 1-8	Inflammation, immunology	Omega Therapeutic	Pre-clinical
HNF4A	HNF4A	Liver regeneration	Omega Therapeutic	Pre-clinical
SFRP1	SFRP1	Alopecia	Omega Therapeutic	Pre-clinical

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mRNA as Epigenomic Controller יִשְׂרָאֵל

Modality