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February 16, 2022/eMedClub News/--On February 9, 2022, Sirnaomics, a leading biopharmaceutical company focused on the discovery and development of RNAi therapeutics, announced the launch of its small interfering RNA Phase I clinical trial study of (siRNA) candidate STP707 by intravenous systemic administration in the treatment of various solid tumors
.
Two patients have been treated so far
.
The Phase I clinical trial is a multicenter, double-blind, dose-escalating and dose-expansion study that will evaluate the safety, tolerability and antitumor activity of STP707 administered intravenously
.
Enrolled subjects were patients with advanced solid tumors that were refractory to standard therapy
.
This research project will have five groups of patients who will receive one of five doses of STP707 by intravenous infusion and a 28-day cycle
.
The primary endpoint is to determine the maximum tolerated dose and to establish a dose recommendation for future phase II studies
.
Additional secondary endpoints were to determine the pharmacokinetics of STP707 and observe preliminary antitumor activity
.
STP707 consists of two siRNA oligonucleotides targeting TGF-β1 and COX-2 mRNA, and combined with a carrier of histidine-lysine copolypeptide (HKP+H) to formulate a nanoparticle formulation
.
Each individual siRNA has the ability to inhibit the expression of the corresponding target mRNA
.
STP707 can also simultaneously inhibit the expression of TGF-β1 and COX-2, resulting in a synergistic effect and reducing the inflammatory response
.
Overexpression of TGF-β1 and COX-2 has been shown to play key regulatory roles in tumorigenesis
.
STP707 utilizes dual-targeted inhibition properties and Sirnaomics’ proprietary peptide nanoparticle (PNP) delivery technology to enhance targeted drug delivery to solid and metastatic tumors through systemic administration
.
In a preclinical study of STP707, knockdown of TGF-β1 and COX-2 gene expression in organs including the liver and lung was observed following intravenous administration
.
Furthermore, STP707 showed antitumor activity against multiple solid tumor types in multiple preclinical models
.
"The first intravenous administration of STP707 in patients with hepatocellular carcinoma and other types of solid tumors is an important milestone as we seek to advance this novel siRNA therapy, which is demonstrated in our preclinical efficacy and safety studies.
Shows promising activity
.
" Sirnaomics founder and president and CEO Patrick Lu, Ph.
D.
, said, "Our goal is to utilize PNP-formulated siRNA therapies to address unmet clinical needs, particularly in oncology and fibrotic diseases.
Sirnaomics Company Sirnaomics was established
in
the United States in 2007.
It is a global biopharmaceutical company specializing in the R&D and industrialization of RNA drugs and vaccines, mainly focusing on cancer, viral infections, fibrosis, and liver metabolic diseases and other therapeutic areas
.
Sirnaomics is the first clinical-stage RNA therapy company with significant market positions in China and the United States, and is the first globally to achieve positive Phase IIa clinical results in oncology using RNAi therapy
.
The key to the success of RNA drug development lies in the drug delivery platform, which protects the RNA from being dissolved in the blood and delivers the RNA to the target cells
.
Sirnaomics has developed a unique PNP introduction technology and a novel GalNAc RNAi drug delivery platform
.
PNP - composed of natural amino acids, its degradation products are naturally non-toxic, overcoming the targeting and stability obstacles of drugs
.
And it can also be administered locally or systemically, with low toxicity, easy manufacture, and delivery of therapeutic drugs to many target organs other than the liver
.
At the same time, PNP can deliver both siRNA and mRNA, and can carry multiple siRNAs with different targeting at the same time, so that it can produce a synergistic gene silencing effect in the same targeted cells, thereby improving the drug efficacy of RNAi
.
GalNAc RNAi delivery platforms, GalAhead and PDoV, can achieve high-efficiency specific delivery to hepatocytes through enhanced endosomal escape properties and dual/multiple siRNA target design
.
In addition, Sirnaomics is continuously developing new nucleic acid drug delivery platforms, including different combinations of siRNA/chemical drug conjugates, peptide ligand tumor targeting, and drug delivery through the respiratory tract for disease treatment
.
Sirnaomics' core product candidate, as well as multiple other clinical-stage product candidates, utilize PNP technology
.
The positive clinical results of its STP705 product candidate developed based on the PNP delivery platform in the treatment of squamous cell carcinoma in situ (isSCC), basal cell carcinoma (BCC), etc.
, demonstrate the efficacy and safety of PNP
.
Based on this platform, Sirnaomics has continuously expanded its product pipeline, and has deployed multiple disease areas, with indications ranging from hepatocyte-related diseases to tumors, fibrosis, skin, viral infections, and cardiovascular diseases.
.
▲Sirnaomics product pipeline (Image source: Sirnaomics official website) At this stage, the two most eye-catching core products of Sirnaomics are dual-target RNAi drugs with first-in-class advantages - STP707 and STP705
.
STP705 is a dual inhibitor of TGF-β1/COX-2 and is currently in clinical phase IIb
.
TGF-β1 is overexpressed in a variety of cancers, including skin cancer and liver cancer; chronic elevation of COX-2 leads to chronic liver inflammation, fibrosis, and cirrhosis, and is also found in skin cancers (squamous cell carcinoma, SCC, and basal cell carcinoma).
Cancer BCC) patients are also overexpressed
.
STP705 can simultaneously inhibit the expression of TGF-β1 and COX-2, and inhibit the growth of tumor cells by inhibiting tumor cell proliferation, epithelial-mesenchymal transition, angiogenesis and other mechanisms
.
For fibrotic diseases, simultaneous inhibition of TGF-β1 and COX-2 can reverse the formation of fibrotic scars by reducing inflammation and activating apoptosis of fibroblasts
.
STP705 uses PNP delivery technology to directly act on diseased tissues through local administration.
Clinical trials are currently being carried out for various skin cancers, skin tissue fibrosis and liver cancer
.
In the research and development of mRNA therapy and vaccines, RNAimmune, a subsidiary of Sirnaomics, currently has a pipeline of candidate products including new crown vaccines, influenza vaccines, rabies vaccines, herpes zoster vaccines, broad-spectrum RAS vaccines and other tumor vaccines
.
One of RNAimmune's core products, RIM730, a vaccine candidate against 2019-nCoV, consists of mRNA encoding the full-length spike protein of the delta variant SARS-CoV-2 configured using lipid nanoparticle (LNP) delivery technology.
The method is intramuscular injection
.
Preclinical results in an in vivo mouse model showed that RIM730 successfully induced a strong immune response with positive trial results
.
Reference: 1.
https://sirnaomics.
com/en/news-room/press-release/20220209/
.
Two patients have been treated so far
.
The Phase I clinical trial is a multicenter, double-blind, dose-escalating and dose-expansion study that will evaluate the safety, tolerability and antitumor activity of STP707 administered intravenously
.
Enrolled subjects were patients with advanced solid tumors that were refractory to standard therapy
.
This research project will have five groups of patients who will receive one of five doses of STP707 by intravenous infusion and a 28-day cycle
.
The primary endpoint is to determine the maximum tolerated dose and to establish a dose recommendation for future phase II studies
.
Additional secondary endpoints were to determine the pharmacokinetics of STP707 and observe preliminary antitumor activity
.
STP707 consists of two siRNA oligonucleotides targeting TGF-β1 and COX-2 mRNA, and combined with a carrier of histidine-lysine copolypeptide (HKP+H) to formulate a nanoparticle formulation
.
Each individual siRNA has the ability to inhibit the expression of the corresponding target mRNA
.
STP707 can also simultaneously inhibit the expression of TGF-β1 and COX-2, resulting in a synergistic effect and reducing the inflammatory response
.
Overexpression of TGF-β1 and COX-2 has been shown to play key regulatory roles in tumorigenesis
.
STP707 utilizes dual-targeted inhibition properties and Sirnaomics’ proprietary peptide nanoparticle (PNP) delivery technology to enhance targeted drug delivery to solid and metastatic tumors through systemic administration
.
In a preclinical study of STP707, knockdown of TGF-β1 and COX-2 gene expression in organs including the liver and lung was observed following intravenous administration
.
Furthermore, STP707 showed antitumor activity against multiple solid tumor types in multiple preclinical models
.
"The first intravenous administration of STP707 in patients with hepatocellular carcinoma and other types of solid tumors is an important milestone as we seek to advance this novel siRNA therapy, which is demonstrated in our preclinical efficacy and safety studies.
Shows promising activity
.
" Sirnaomics founder and president and CEO Patrick Lu, Ph.
D.
, said, "Our goal is to utilize PNP-formulated siRNA therapies to address unmet clinical needs, particularly in oncology and fibrotic diseases.
Sirnaomics Company Sirnaomics was established
in
the United States in 2007.
It is a global biopharmaceutical company specializing in the R&D and industrialization of RNA drugs and vaccines, mainly focusing on cancer, viral infections, fibrosis, and liver metabolic diseases and other therapeutic areas
.
Sirnaomics is the first clinical-stage RNA therapy company with significant market positions in China and the United States, and is the first globally to achieve positive Phase IIa clinical results in oncology using RNAi therapy
.
The key to the success of RNA drug development lies in the drug delivery platform, which protects the RNA from being dissolved in the blood and delivers the RNA to the target cells
.
Sirnaomics has developed a unique PNP introduction technology and a novel GalNAc RNAi drug delivery platform
.
PNP - composed of natural amino acids, its degradation products are naturally non-toxic, overcoming the targeting and stability obstacles of drugs
.
And it can also be administered locally or systemically, with low toxicity, easy manufacture, and delivery of therapeutic drugs to many target organs other than the liver
.
At the same time, PNP can deliver both siRNA and mRNA, and can carry multiple siRNAs with different targeting at the same time, so that it can produce a synergistic gene silencing effect in the same targeted cells, thereby improving the drug efficacy of RNAi
.
GalNAc RNAi delivery platforms, GalAhead and PDoV, can achieve high-efficiency specific delivery to hepatocytes through enhanced endosomal escape properties and dual/multiple siRNA target design
.
In addition, Sirnaomics is continuously developing new nucleic acid drug delivery platforms, including different combinations of siRNA/chemical drug conjugates, peptide ligand tumor targeting, and drug delivery through the respiratory tract for disease treatment
.
Sirnaomics' core product candidate, as well as multiple other clinical-stage product candidates, utilize PNP technology
.
The positive clinical results of its STP705 product candidate developed based on the PNP delivery platform in the treatment of squamous cell carcinoma in situ (isSCC), basal cell carcinoma (BCC), etc.
, demonstrate the efficacy and safety of PNP
.
Based on this platform, Sirnaomics has continuously expanded its product pipeline, and has deployed multiple disease areas, with indications ranging from hepatocyte-related diseases to tumors, fibrosis, skin, viral infections, and cardiovascular diseases.
.
▲Sirnaomics product pipeline (Image source: Sirnaomics official website) At this stage, the two most eye-catching core products of Sirnaomics are dual-target RNAi drugs with first-in-class advantages - STP707 and STP705
.
STP705 is a dual inhibitor of TGF-β1/COX-2 and is currently in clinical phase IIb
.
TGF-β1 is overexpressed in a variety of cancers, including skin cancer and liver cancer; chronic elevation of COX-2 leads to chronic liver inflammation, fibrosis, and cirrhosis, and is also found in skin cancers (squamous cell carcinoma, SCC, and basal cell carcinoma).
Cancer BCC) patients are also overexpressed
.
STP705 can simultaneously inhibit the expression of TGF-β1 and COX-2, and inhibit the growth of tumor cells by inhibiting tumor cell proliferation, epithelial-mesenchymal transition, angiogenesis and other mechanisms
.
For fibrotic diseases, simultaneous inhibition of TGF-β1 and COX-2 can reverse the formation of fibrotic scars by reducing inflammation and activating apoptosis of fibroblasts
.
STP705 uses PNP delivery technology to directly act on diseased tissues through local administration.
Clinical trials are currently being carried out for various skin cancers, skin tissue fibrosis and liver cancer
.
In the research and development of mRNA therapy and vaccines, RNAimmune, a subsidiary of Sirnaomics, currently has a pipeline of candidate products including new crown vaccines, influenza vaccines, rabies vaccines, herpes zoster vaccines, broad-spectrum RAS vaccines and other tumor vaccines
.
One of RNAimmune's core products, RIM730, a vaccine candidate against 2019-nCoV, consists of mRNA encoding the full-length spike protein of the delta variant SARS-CoV-2 configured using lipid nanoparticle (LNP) delivery technology.
The method is intramuscular injection
.
Preclinical results in an in vivo mouse model showed that RIM730 successfully induced a strong immune response with positive trial results
.
Reference: 1.
https://sirnaomics.
com/en/news-room/press-release/20220209/
