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.
Yaohai Bio-Pharma Offers One-Stop Solution for RNA
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
|
EN
AR
HR
CS
DA
NL
FI
FR
DE
EL
IT
JA
KO
NO
PL
PT
RO
RU
ES
SV
IW
ID
LV
LT
SR
SK
SL
UK
VI
ET
HU
TH
TR
FA
AF
MS
BE
MK
UR
BN
